CompletedPhase 2

Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Germany108 participantsStarted 2009-06

Plain-language 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

Who can participate

Age range18 Years – 35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3

Timeframe: 4 months

Trial details

NCT IDNCT00915915

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04

View on ClinicalTrials.gov More Contraception trials