check_circleStudy Completed

Dysmenorrhea

Bayer Identifier:
91616
ClinicalTrials.gov Identifier:
NCT00461305
EudraCT Number:
Not Available
EU CT Number:
Not Available
Safety study of Ethinylestradiol/Drospirenone in dysmenorrhea

Trial purpose

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Key Participants Requirements

Sex

Female

Age

20 Years
  • - Patients aged 20 years or older at obtaining informed consent
    - Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
    - Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment
  • - Patients with ovarian chocolate cysts
    - Patients with fibroid needed to be treated
    - Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
    - Patients with undiagnosed abnormal vaginal bleeding
    - Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease 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 prodromata
    - Patients with pulmonary hypertension or valvular heart disease
    - Patients who are regularly taking nutritional products that contain St. John's Wort
    - Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
    - Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Trial summary

Enrollment Goal
420
Trial Dates
February 2007 - August 2009
Phase
Phase 2/Phase 3
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Koga ClinicSendai, 981-0933, Japan
Completed
Kakuta Chieko ClinicSendai, 984-0042, Japan
Completed
Yazaki ClinicTakasaki, 370-0883, Japan
Completed
Takane ClinicShinagawa-ku, 140-0013, Japan
Completed
Seijo Kinoshita HospitalSetagaya-ku, 157-0066, Japan
Completed
Kosugi ClinicSetagaya-ku, 156-0042, Japan
Completed
Women's Wellness Ginza ClinicChuo-ku, 104-0061, Japan
Completed
C:z Ladies ClinicShibuya-ku, 150-0013, Japan
Completed
NS ClinicHachioji, 192-0046, Japan
Completed
Machida Higashiguchi ClinicMachida, 194-0022, Japan
Completed
Iida Ladies ClinicNagoya, 460-0007, Japan
Completed
Sakie Ladies ClinicNagoya, 464-0066, Japan
Completed
Chayamachi Ladies ClinicOsaka, 530-0013, Japan
Completed
Kawabata Women's ClinicOsaka, 534-0014, Japan
Completed
Nagaike ClinicSendai, 980-0021, Japan
Completed
Iesaka ClinicMaebashi, 371-0024, Japan
Completed
Suzuran ClinicSuginami-ku, 167-0051, Japan
Completed
Ito Medical ClinicOta-ku, 144-0052, Japan
Completed
Ikebukuro ClinicToshima-ku, 171-0021, Japan
Completed
Kichijyouji Lady's ClinicMusashino, 180-0003, Japan
Completed
Luna ClinicYokohama, 231-0861, Japan
Completed
Rinkan ClinicYamato, 242-0007, Japan
Completed
Kano's Clinic for WomenNagoya, 460-0011, Japan
Completed
Yoshimura Ladies ClinicToyonaka, 560-0022, Japan
Completed
Hanabusa ClinicKobe, 650-0021, Japan
Completed
Kiuchi Ladies ClinicNishinomiya, 663-8204, Japan

Primary Outcome

  • Number of participants with intracyclic bleeding at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with a change in Total Dysmenorrhea Score from baseline to Cycle 6
    date_rangeTime Frame:
    From baseline up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with a change in Total Dysmenorrhea Score from baseline to Cycle 13
    date_rangeTime Frame:
    From baseline up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Total Dysmenorrhea Score at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Total Dysmenorrhea Score at Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of lower abdominal pain during menstruation at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of lower abdominal pain during menstruation at Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of lumbago during menstruation at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of lumbago during menstruation at Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of headache during menstruation at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of headache during menstruation at Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of nausea or vomiting during menstruation at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of Severity of nausea or vomiting during menstruation at Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with a Total Pelvic Pain Score of 0 up to 6 at times other than during menstruation at Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with a Total Pelvic Pain Score of 0 up to 6 at times other than during menstruation at Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation from baseline to Cycle 6
    date_rangeTime Frame:
    From baseline up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in Visual Analogue Scale (VAS) for dysmenorrhea at times other than during menstruation from baseline to Cycle 13
    date_rangeTime Frame:
    From baseline up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation from baseline to Cycle 6
    date_rangeTime Frame:
    From baseline up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in Visual Analogue Scale (VAS) for pelvic pain at times other than during menstruation from baseline to Cycle 13
    date_rangeTime Frame:
    From baseline up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of Any Bleeding Episodes from Cycle 1 to Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of Any Bleeding Episodes from Cycle 1 to Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of Any Bleeding Days from Cycle 1 to Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of any bleeding days from Cycle 1 to Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with intracyclic bleeding from Cycle 1 to Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with intracyclic bleeding from Cycle 1 to Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with withdrawal bleeding from Cycle 1 to Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with withdrawal bleeding from Cycle 1 to Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
    date_rangeTime Frame:
    Up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
    date_rangeTime Frame:
    Up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in serum carbohydrate antigen-125 (CA-125) from baseline to Cycle 6
    date_rangeTime Frame:
    From baseline up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in serum CA-125 from baseline to Cycle 13
    date_rangeTime Frame:
    From baseline up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in serum C-reactive protein (CRP) from baseline to Cycle 6
    date_rangeTime Frame:
    From baseline up to Cycle 6 (168 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No
  • Change in serum CRP from baseline to Cycle 13
    date_rangeTime Frame:
    From baseline up to Cycle 13 (364 days) with 28 days per cycle
    enhanced_encryption
    Safety Issue:
    No

Trial design

A multicenter, single-blind, randomized study, to investigate efficacy of ethinylestradiol for intracyclic bleeding profile during 24 weeks (6 cycles) by oral administration of drospirenone 3 mg/ethinylestradiol 20 µg and drospirenone 3 mg/ ethinylestradiol 30 µg in patients with dysmenorrheal and to investigate the long term safety oral administration of drospirenone 3 mg/ethinylestradiol 20 µg administered for 52 weeks (13 cycles)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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