Status:
COMPLETED
Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatmen...
Eligibility Criteria
Inclusion
- Healthy female volunteers
- age 18 - 35 years (smoker not older than 30 years, inclusive)
- ovulatory pre-treatment cycle
Exclusion
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
- Regular intake of medication other than Oral Contraception
- Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01204190
Start Date
September 1 2010
End Date
August 1 2011
Last Update
November 4 2014
Active Locations (2)
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1
Berlin, State of Berlin, Germany, 10115
2
Groningen, Netherlands, 9713 GZ