Trial Condition(s):
Contraception
Inhibition of ovulation and pharmacokinetics of transdermal ethinylestradiol (EE) and Gestodene (GSD)
Bayer Identifier:
14348
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Schering Pharma AG Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, open-label, randomized study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg ethinylestradiol and either 1.05 or 2.1 mg gestodene in healthy young female volunteers over a period of 3 treatment cycles
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3Timeframe: 4 months
Secondary Outcome
- The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3Timeframe: 4 months
- Course of gonadotropins (FSH, LH, P, E2)Timeframe: 4 months
- Endometrial thickness and Follicle sizeTimeframe: 4 months
- Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3Timeframe: 4 Months
- Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3Timeframe: 4 Months
Additional Information
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