NL-OMON34076
Completed
Phase 2
Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles - Pharmacodynamic and -kinetic study of 3 transdermal EE and GSD formulations
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- contraception
- Sponsor
- Bayer
- Enrollment
- 110
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy female volunteers
- •age 18 \- 35 years (smoker not older than 30 years, inclusive)
- •ovulatory pre\-treatment cycle
Exclusion Criteria
- •\- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
- •\- Regular intake of medication other than Oral Contraception
- •\- Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
Outcomes
Primary Outcomes
Not specified
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