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Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01638910
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.

Condition or disease Intervention/treatment Phase
Contraception Drug: EV/DNG (Qlaira, BAY86-5027) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 955 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest in a 28-day Regimen for 13 Cycles in Healthy Female Subjects
Study Start Date : June 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EV/DNG (Qlaira, BAY86-5027) Drug: 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)




Primary Outcome Measures :
  1. Number of unintended pregnancies [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]

Secondary Outcome Measures :
  1. Number of expected bleeding days [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]
  2. Number of unexpected bleeding days [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]
  3. Number of expected bleeding episodes [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]
  4. Number of unexpected bleeding episodes [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]
  5. Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Cycle 13 (1 Cycle = 28 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception
  • Smokers may not exceed 35 years of age

Exclusion Criteria:

  • Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638910


Locations
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China, Guangdong
Guangzhou,, Guangdong, China, 510405
Guangzhou, Guangdong, China, 510120
China, Hebei
Shijiazhuang, Hebei, China, 050051
China, Hubei
Wuhan, Hubei, China, 430030
Wuhan, Hubei, China, 430032
China, Hunan
Changsha, Hunan, China, 410013
Hengyang, Hunan, China, 421001
China, Jiangsu
Nanjing, Jiangsu, China, 210009
China, Liaoning
Dalian, Liaoning, China, 116011
Shenyang, Liaoning, China, 110004
China, Shandong
Jinan, Shandong, China, 250012
China, Sichuan
Chengdu, Sichuan, China, 610041
China, Zhejiang
Wenzhou, Zhejiang, China, 325027
China
Beijing, China, 100044
Beijing, China, 100730
Chongqing, China, 400016
Chongqing, China, 400038
Chongqing, China, 400042
Shanghai, China, 200025
Shanghai, China, 200030
Shanghai, China, 200127
Shanghai, China, 2100129
Tianjin, China, 300211
Hong Kong
Hongkong, Hong Kong
India
Pune, Maharashtra, India, 411001
Chandigarh, India
Karnal, India, 132001
New Delhi, India, 110 029
Pune, India, 411004
Secunderabad, India, 500003
Taiwan
Kaohsiung, Taiwan, 80756
Taichung, Taiwan, 40705
Taipei, Taiwan, 100
Taipei, Taiwan, 11217
Taipei, Taiwan, 116
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10700
Chiangmai, Thailand, 50200
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01638910    
Other Study ID Numbers: 91773
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Efficacy
Safety
oral contraception
estradiol valerate
dienogest