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Completed

NCT Number: NCT00511797

SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Maebashi, Gunma, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 20 years or older at obtaining informed consent
  • Patients having the normal menstrual cycle (28+/-3 days) in the latest two menses before the final enrollment
  • Patients having a total dysmenorrhea score of at least 3 points in two menstrual cycles before the final enrollment

Exclusion criteria

  • Patients with ovarian chocolate cysts and symptomatic uterine fibroids (as defined in greater detail in the study protocol)
  • Patients with estrogen-dependent tumors (e.g. breast cancer, cancer of the uterine body or breast fibrocystic, etc.), and patients with cervical cancer or suspected cervical cancer (e.g. class III or greater in the cervical smear or endometrial smear examination.)
  • Patients with undiagnosed abnormal vaginal bleeding
  • Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease(including transient ischemic attack, etc.), or coronary artery disease(e.g. myocardial infarction and angina pectoris, etc.), or a history of those diseases
  • Patients aged 35 years or older who smoke at least 15 cigarettes per day
  • Patients with migraine accompanied by prodrome (e.g. scintillating scotoma or star-shaped scintillation)
  • Patients with pulmonary hypertension or valvular heart disease complicated by atrial fibrillation, and patients with a history of subacute bacterial endocarditis
  • Patients who are regularly taking nutritional products that contain St. John's Wort
  • Patients who underwent surgical treatment for endometriosis by laparotomy, or laparoscopy within 2 months prior to screening
  • Patients who need to use analgesics regularly for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Treatment and study plan

SH T04740B

Drug

Drospirenone 1mg/EE 20µg (ß-CDC)

SH T00186DF

Drug

Drospirenone 3 mg/EE 20µg (ß-CDC)

SH T04740F

Drug

Drospirenone 2 mg/EE 20µg (ß-CDC)

Placebo

Drug

Placebo

Primary outcomes

  1. Change From Baseline in Total Dysmenorrheal Score at Final Evaluation

    Time frame: Baseline and up to 4 Cycles (28 days per cycle)

    Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)

Secondary outcomes

  1. Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4

    Time frame: Baseline and up to 4 Cycles (28 days per cycle)

    Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.

  2. Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4

    Time frame: Cycle 4 (28 days per cycle)

    Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

  3. Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4

    Time frame: Cycle 4 (28 days per cycle)

    Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

  4. Number of Participants With Severity of Headache During Menstruation at Cycle 4

    Time frame: Cycle 4 (28 days per cycle)

    Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

  5. Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4

    Time frame: Cycle 4 (28 days per cycle)

    Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).

  6. Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4

    Time frame: Cycle 4 (28 days per cycle)

    Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.

  7. Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4

    Time frame: From baseline up to Cycle 4 (28 days per cycle)

    VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).

  8. Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4

    Time frame: Cycle 4 (28 days per cycle)

    VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).

  9. Change From Baseline in Endometrial Thickness After 4-cycle Treatment

    Time frame: From baseline to Cycle 4 (28 days per cycle)

    Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.

  10. Number of Bleeding / Spotting Episodes

    Time frame: For the first 90 days

    Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.

  11. Number of Bleeding / Spotting Days

    Time frame: For the first 90 days

    Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.

  12. Participants With Withdrawal Bleeding

    Time frame: At Cycle 4 (28 days per cycle)

    Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.

  13. Participants With Intracyclic Bleeding

    Time frame: At Cycle 4 (28 days per cycle)

    Intracyclic bleedings were defined as bleedings while a participant takes active drugs.

  14. Participants With Non-heavy Intracyclic Bleeding

    Time frame: At Cycle 4 (28 days per cycle)

    Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).

  15. Participants With Non-heavy Withdrawal Bleeding

    Time frame: At Cycle 4 (28 dyas per cycle)

    Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).

  16. Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment

    Time frame: From baseline to Cycle 4 (28 days per cycle)

    CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.

  17. Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment

    Time frame: From baseline to Cycle 4 (28 days per cycle)

    CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.

  18. Change From Baseline in Serum Estradiol Level After 4-cycle Treatment

    Time frame: From baseline to Cycle 4 (28 days per cycle)

    Estradiol is a predominant sex hormone that presents in female.

  19. Change From Baseline in Serum Progesterone Level at Cycle 4

    Time frame: From baseline to Cycle 4 (28 days per cycle)

    Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled Comparative Study to Investigate the Optimal Dose of Drospirenone for Dysmenorrhea With SH T04740A [Drospirenone 1 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)], SH T 04740E [Drospirenone 2 mg/Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] and SH T00186D [Drospirenone 3 mg/ Ethinylestradiol 20 µg (as ß-cyclodextrin Clathrate)] Administered Orally for 16 Weeks (4 Cycles), and to Confirm the Efficacy of SH T00186D for Dysmenorrhea.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 6, 2007
Registry last updated
Jan 26, 2017

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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