Trial Condition(s):

Metrorrhagia

Study of a 4-phasic oral contraceptive for the treatment of heavy menstrual bleeding

Bayer Identifier:

91774

ClinicalTrials.gov Identifier:

NCT01638923

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

Inclusion Criteria
- Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception
 - 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
- Current diagnosis of organic uterine bleeding
 - 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

Trial Summary

Enrollment Goal
339
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Singapore, Singapore, 229899

Status
Terminated
 
Locations

Investigative Site

Singapore, Singapore, 169608

Status
Terminated
 
Locations

Investigative Site

Ivanovo, Russia, 153045

Status
Completed
 
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Investigative Site

Krasnodar, Russia, 350012

Status
Completed
 
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Investigative Site

Irkutsk, Russia, 664003

Status
Completed
 
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Investigative Site

St. Petersburg, Russia, 199034

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 119415

Status
Terminated
 
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Investigative Site

Bangkok, Thailand, 10700

Status
Completed
 
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Investigative Site

Bangkok, Thailand, 10330

Status
Completed
 
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Investigative Site

Manila, Philippines

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 100

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 11217

Status
Terminated
 
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Investigative Site

Tainan, Taiwan, China

Status
Completed
 
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Investigative Site

Quezon City, Philippines

Status
Completed
 
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Investigative Site

Beijing, China, 100730

Status
Completed
 
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Investigative Site

Shanghai, China, 200090

Status
Completed
 
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Investigative Site

Jinan, China, 250012

Status
Completed
 
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Investigative Site

Guangzhou, China, 510120

Status
Completed
 
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Investigative Site

Beijing, China, 100034

Status
Completed
 
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Investigative Site

Beijing, China, 100044

Status
Completed
 
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Investigative Site

Shenyang, China, 110004

Status
Completed
 
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Investigative Site

Chongqing, China, 400010

Status
Completed
 
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Investigative Site

Dalian, China, 116011

Status
Completed
 
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Investigative Site

Shanghai, China, 200030

Status
Completed
 
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Investigative Site

Wuhan, China, 430022

Status
Completed
 
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Investigative Site

Xi'an, China, 710032

Status
Completed
 
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Investigative Site

Qingdao, China, 266071

Status
Terminated
 
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Investigative Site

Changchun, China

Status
Completed
 
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Investigative Site

Tianjin, China, 300193

Status
Completed
 
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Investigative Site

Tianjin, China, 300211

Status
Completed
 
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Investigative Site

Shijiazhuang, China, 050051

Status
Completed
 
Locations

Investigative Site

Wuhan, China, 430030

Status
Completed
 
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Investigative Site

Chengdu, China, 610072

Status
Completed
 
Locations

Investigative Site

Nanning, China, 530021

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100026

Status
Completed
 
Locations

Investigative Site

Hengyang, China, 421001

Status
Completed
 
Locations

Investigative Site

Changsha, China, 410013

Status
Completed
 
Locations

Investigative Site

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 194354

Status
Terminated
 
Locations

Investigative Site

Moscow, Russia, 117049

Status
Completed
 

Trial Design