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Completed

NCT Number: NCT01638923

Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

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Key information

Conditions

Metrorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception
  • Willingness to use barrier contraception (e.g., condoms) from screening to study completion
  • Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion

Exclusion criteria

  • Current diagnosis of organic uterine bleeding
  • History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1.
  • Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]).
  • Clinically significant abnormal results of breast examination (breast palpation).
  • Positive pregnancy test at Visit 1
  • Less than three months since delivery, abortion, or lactation before to start Visit 1
  • Other contraceptive methods
  • Any disease or condition that may worsen under hormonal treatment
  • Smokers over the age of 35
  • Body mass index >32

Treatment and study plan

EV/DNG (Qlaira, Natazia, BAY86-5027)

Drug

2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.

Placebo

Drug

Matching placebo to be taken orally daily for 7 cycles of 28 days each.

Primary outcomes

  1. Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days

    Time frame: 90 day baseline period and 90 days during treatment period

Secondary outcomes

  1. Proportion of subjects with successful treatment

    Time frame: 90 days during treatment phase

    Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in period

  2. Percent change of MBL at baseline and 90 day period during treatment phase

    Time frame: Baseline and 90 days during treatment phase

  3. Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)

    Time frame: Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7

  4. Proportion of subjects with improvement in the investigator's global assessment scale on Day 84

    Time frame: Treatment day 84

    Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.

  5. Proportion of subjects with improvement in the investigator's global assessment scale on Day 196

    Time frame: Treatment day 196

    Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.

  6. Proportion of subjects with improvement in the subject's global assessment scale on Day 84

    Time frame: Treatment day 84

    Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.

  7. Proportion of subjects with improvement in the subject's global assessment scale on Day 196

    Time frame: Treatment day 196

    Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.

  8. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2012
Registry last updated
Jul 10, 2015

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

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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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