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OpenTrials
Completed

NCT Number: NCT00764881

Effects of SH T00658ID on Libido

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

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Key information

Conditions

Contraception Genital Diseases Libido Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sydney Centre for Reproductive Health Reseach, Ashfield, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
  • Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion criteria

  • Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Drug

Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose

Microgynon

Drug

Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.

Placebo

Drug

Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

Primary outcomes

  1. Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

  2. Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

Secondary outcomes

  1. The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline

    Time frame: At Baseline

    Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).

  2. The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).

  3. Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).

  4. The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline

    Time frame: At Baseline

    Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  5. The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  6. Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).

  7. The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline

    Time frame: At Baseline

    Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  8. The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  9. Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).

  10. The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline

    Time frame: At Baseline

    Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  11. The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  12. Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).

  13. The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline

    Time frame: At Baseline

    Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).

  14. The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).

  15. Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).

  16. The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.

    Time frame: At Baseline

    Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  17. The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  18. Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).

  19. The Mean Absolute Values of FSFI Total Score at Baseline

    Time frame: At Baseline

    The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).

  20. The Mean Absolute Values of FSFI Total Score at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).

  21. Mean Change From Baseline to Cycle 6 in FSFI Total Score

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).

  22. The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline

    Time frame: At Baseline

    Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).

  23. The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).

  24. Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).

  25. The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline

    Time frame: At Baseline

    Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).

  26. The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).

  27. Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

  28. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline

    Time frame: At Baseline

    The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant

  29. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant

  30. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).

  31. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline

    Time frame: At Baseline

    Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  32. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  33. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).

  34. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline

    Time frame: At Baseline

    Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  35. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  36. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).

  37. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline

    Time frame: At Baseline

    Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  38. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  39. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).

  40. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline

    Time frame: At Baseline

    Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  41. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  42. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).

  43. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline

    Time frame: At Baseline

    General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  44. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  45. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).

  46. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline

    Time frame: At Baseline

    Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  47. The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  48. Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).

  49. Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

  50. Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

  51. Vaginal Effects Evaluated by Vaginal pH at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick

  52. Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline

    Time frame: At Baseline

    ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).

  53. Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).

  54. Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).

  55. Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline

    Time frame: At Baseline

    The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).

  56. Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).

  57. Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)

    Time frame: Baseline up to Cycle 6 (28 days per Cycle)

    The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).

  58. Number of Bleeding / Spotting Days in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  59. Number of Bleeding / Spotting Days in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to 180 during study treatment

  60. Number of Bleeding / Spotting Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes

  61. Number of Bleeding / Spotting Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment

  62. Mean Length of Bleeding / Spotting Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes

  63. Mean Length of Bleeding / Spotting Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  64. Maximum Length of Bleeding / Spotting Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  65. Maximum Length of Bleeding / Spotting Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  66. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  67. Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  68. Number of Spotting Only Days in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  69. Number of Spotting Only Days in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  70. Number of Spotting Only Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  71. Number of Spotting Only Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  72. Mean Length of Spotting-only Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  73. Mean Length of Spotting-only Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  74. Maximum Length of Spotting-only Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  75. Maximum Length of Spotting-only Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  76. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1

    Time frame: From Day 1 to Day 90

    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  77. Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2

    Time frame: From Day 91 to Day 180

    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  78. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  79. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  80. Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  81. Length of Withdrawal Bleeding Episodes at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  82. Length of Withdrawal Bleeding Episodes at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  83. Length of Withdrawal Bleeding Episodes at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  84. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

  85. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

  86. Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

  87. Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

  88. Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

  89. Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

  90. Onset of Withdrawal Bleeding Episodes at Cycle 1

    Time frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1

    Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

  91. Onset of Withdrawal Bleeding Episodes at Cycle 3

    Time frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3

    Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

  92. Onset of Withdrawal Bleeding Episodes at Cycle 6

    Time frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6

    Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

  93. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  94. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  95. Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  96. Number of Intracyclic Bleeding Episodes at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  97. Number of Intracyclic Bleeding Episodes at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  98. Number of Intracyclic Bleeding Episodes at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  99. Maximum Length of Intracyclic Bleeding Episodes at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  100. Maximum Length of Intracyclic Bleeding Episodes at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  101. Maximum Length of Intracyclic Bleeding Episodes at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  102. Number of Intracyclic Bleeding Days at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  103. Number of Intracyclic Bleeding Days at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  104. Number of Intracyclic Bleeding Days at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  105. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1

    Time frame: At Cycle 1 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

  106. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3

    Time frame: At Cycle 3 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

  107. Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6

    Time frame: At Cycle 6 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

  108. Percentage of Participants With at Least 1 Intracyclic Bleeding Episode

    Time frame: Up to Cycle 6 (28 days per Cycle)

    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2008
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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