Trial Condition(s):

Contraception, Ovulation inhibition

Inhibition of ovulation, patch, ethinylestradiol and gestodene

Bayer Identifier:

91558

ClinicalTrials.gov Identifier:

NCT00729404

EudraCT Number:

2008-001198-13

Terminated/Withdrawn

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
- Signed informed consent,
 - BMI: 18 - 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/arterial 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
17
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
Status
LocationsStatus
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Terminated
 
Locations

Bayer Schering Pharma AG - Clin. Pharm. Berlin

Berlin, Germany, 13342

Status
Terminated
 
Locations

Landesamt für Gesundheit und Soziales

Berlin, Germany, 10707

Status
Terminated
 

Trial Design