Trial Condition(s):

Contraception, Ovulation inhibition

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

Bayer Identifier:

14348

ClinicalTrials.gov Identifier:

NCT00915915

EudraCT Number:

2009-009177-10

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

Loading...
Locations
Status
LocationsStatus
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 
Locations

Bayer Schering Pharma AG

Berlin, Germany, 13353

Status
Completed
 

Trial Design