Status:
COMPLETED
Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)
Lead Sponsor:
Bayer
Conditions:
Contraception
Ovulation Inhibition
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
Eligibility Criteria
Inclusion
- BMI: 18 BMI 30 kg/m²
- Healthy female volunteers
- Age 18-35 years (smoker not older than 30 years, inclusive)
- Ovulatory pre-treatment cycle, at least 3 month since delivery
- Abortion or lactation before the first screening examination
- Willingness to use non-hormonal methods of contraception during entire study
Exclusion
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
- Regular intake of medication other than OCs
- Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00915915
Start Date
June 1 2009
End Date
April 1 2010
Last Update
October 28 2014
Active Locations (2)
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1
Berlin, State of Berlin, Germany, 10115
2
Berlin, State of Berlin, Germany, 13353