Trial Condition(s):

Contraception

Inhibition of ovulation and pharmacokinetics of transdermal ethinylestradiol (EE) and Gestodene (GSD)

Bayer Identifier:

14348

ClinicalTrials.gov Identifier:

NCT00915915

EudraCT Number:

2009-009177-10

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
108
Trial Dates
black-arrow
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
Locations
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Locations

Bayer Schering Pharma AG

Berlin, Germany, 13353

Trial Design