Trial Condition(s):

Contraception

US Ovulation Inhibition Study in Obese Women

Bayer Identifier:

13871

ClinicalTrials.gov Identifier:

NCT00873483

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Birth Control Patch Study

Inclusion Criteria
- Female subject requesting contraception
 - Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
 - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
 - History of regular cyclic menstrual periods
 - Willingness to use non-hormonal methods of contraception during the entire study.
Exclusion Criteria
- Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
 - Hypersensitivity to any ingredient of the study drug
 - Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
 - Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
 - Any disease or condition that may worsen under hormonal treatment.

Trial Summary

Enrollment Goal
173
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Houston, United States, 77054

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92108

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98105

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19114

Status
Completed
 
Locations

Investigative Site

Sandy Springs, United States, 30328

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85712

Status
Completed
 

Trial Design