Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding
NCT ID: NCT01638923
Last Updated: 2015-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
339 participants
INTERVENTIONAL
2012-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
EV/DNG (Qlaira, Natazia, BAY86-5027)
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.
Arm 2
placebo
Matching placebo to be taken orally daily for 7 cycles of 28 days each.
Interventions
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EV/DNG (Qlaira, Natazia, BAY86-5027)
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
Matching placebo to be taken orally daily for 7 cycles of 28 days each.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Guangzhou, Guangdong, China
Nanning, Guangxi, China
Shijiazhuang, Hebei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Hengyang, Hunan, China
Dalian, Liaoning, China
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Jinan, Shandong, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Changchun, , China
Chongqing, , China
Qingdao, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Tianjin, , China
Manila, , Philippines
Quezon City, , Philippines
Irkutsk, , Russia
Ivanovo, , Russia
Krasnodar, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Singapore, , Singapore
Singapore, , Singapore
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Countries
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Other Identifiers
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X311965
Identifier Type: OTHER
Identifier Source: secondary_id
91774
Identifier Type: -
Identifier Source: org_study_id
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