Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects
NCT ID: NCT01638910
Last Updated: 2014-12-17
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
955 participants
INTERVENTIONAL
2012-06-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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EV/DNG (Qlaira, BAY86-5027)
EV/DNG (Qlaira, BAY86-5027)
Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
Interventions
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EV/DNG (Qlaira, BAY86-5027)
Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
Eligibility Criteria
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Inclusion Criteria
* Smokers may not exceed 35 years of age
Exclusion Criteria
* Body mass index (BMI) \> 32 kg/m2
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
18 Years
50 Years
FEMALE
Yes
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
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Hengyang, Hunan, China
Nanjing, Jiangsu, China
Dalian, Liaoning, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Chengdu, Sichuan, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Chongqing, , China
Chongqing, , China
Chongqing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Hong Kong, , Hong Kong
Pune, Maharashtra, India
Chandigarh, , India
Karnāl, , India
New Delhi, , India
Pune, , India
Secunderabad, , India
Taipei, Taipei, Taiwan
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, Thailand, Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
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References
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Yu Q, Huang Z, Ren M, Chang Q, Zhang Z, Parke S. Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open-label, uncontrolled Phase III study. Int J Womens Health. 2018 Jun 7;10:257-266. doi: 10.2147/IJWH.S157056. eCollection 2018.
Other Identifiers
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91773
Identifier Type: -
Identifier Source: org_study_id