Trial Condition(s):

Contraception

Efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects

Bayer Identifier:

91773

ClinicalTrials.gov Identifier:

NCT01638910

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
955
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Completed
 
Locations

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 333

Status
Completed
 
Locations

Wan Fang Hospital

Taipei, Taiwan, China, 116

Status
Completed
 
Locations

Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Kaohsiung Medical University Hospital

Kaohsiung , Taiwan, China, 80756

Status
Completed
 
Locations

Queen Mary Hospital

Hongkong, Hong Kong, China

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

King Chulalongkorn Memorial Hospital

Bangkok, Thailand, 10330

Status
Completed
 
Locations

Obstetrics & Gynecology Hosp. of Fudan Univ.

Shanghai, China, 2100129

Status
Completed
 
Locations

Renji Hosp. Shanghai Jiao Tong Univ. School of Medicine

Shanghai, China, 200127

Status
Completed
 
Locations

International Peace Maternity and Child Health Hospital

Shanghai, China, 200030

Status
Completed
 
Locations

Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School

Shanghai, China, 200025

Status
Completed
 
Locations

Peking Union Medical College Hospital

Beijing, China, 100730

Status
Completed
 
Locations

Peking Univ. People's Hosp.

Beijing, China, 100044

Status
Completed
 
Locations

2nd affiliated Hospital, Tianjin Medical University

Tianjin, China, 300211

Status
Completed
 
Locations

Qilu Hosp., Shandong Univ.

Jinan, China, 250012

Status
Completed
 
Locations

Shengjing Hosp. of China Medical Univ.

Shenyang, China, 110004

Status
Terminated
 
Locations

1st Affiliate Hosp., Dalian Med Univ.

Dalian, China, 116011

Status
Completed
 
Locations

People's Hospital of Hebei Province

Shijiazhuang, China, 050051

Status
Completed
 
Locations

Zhongda Hosp. affiliated of Southeast Univ.

Nanjing, China, 210009

Status
Completed
 
Locations

SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.

Guangzhou, China, 510120

Status
Terminated
 
Locations

1st Affiliated Hosp., Guangzhou Univ. TCM

Guangzhou, , China, 510405

Status
Completed
 
Locations

Family Plan Research Inst, Tongji Med Colg, Huazhong Uni

Wuhan, China, 430030

Status
Completed
 
Locations

Union Hospital of Tongji Medical College,Huazhong university

Wuhan, China, 430032

Status
Completed
 
Locations

The First Affilicated Hospital of 3rd Military Med. Uni.PLA

Chongqing, China, 400038

Status
Completed
 
Locations

The Third Affiliated Hospital of Third Military Medical Univ

chongqing, China, 400042

Status
Completed
 
Locations

1st Hosp., Chongqing Medical Univ.

Chongqing, China, 400016

Status
Terminated
 
Locations

The Third Xiangya Hospital of Central South University

Changsha, China, 410013

Status
Completed
 
Locations

1st Affiliated Hospital of Nanhua University

Hengyang, China, 421001

Status
Completed
 
Locations

The Second Affiliated Hospitalof Wenzhou Medical College

Wenzhou, China, 325027

Status
Completed
 
Locations

Maharaj Nakorn Chiang Mai Hospital

Chiangmai, Thailand, 50200

Status
Completed
 
Locations

Sunshine Hospital

Secunderabad, India, 500003

Status
Completed
 
Locations

Bharti Research Institute of Diabetes and Endocrinology

Karnal, India, 132001

Status
Completed
 
Locations

Gupte Hospital and Centre for Research in Reproduction

Pune, India, 411004

Status
Terminated
 
Locations

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Status
Terminated
 
Locations

Ruby Hall Clinic

Pune, India, 411001

Status
Completed
 
Locations

All Inida Institute of Medical Sciences

New Delhi, India, 110 029

Status
Terminated
 
Locations

West China 2nd Hosp., of Sichuan Univ.

Chengdu, China, 610041

Status
Completed
 

Trial Design