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

Phase 2

Completed

• Conditions: Fertility control; contraception

• Registration Number: NL-OMON34076
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of subjects with ovulation in at least one of the treatment<br /><br>cycles 2 and 3. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* course of FSH, LH, estradiol and progesterone levels<br /><br>* follicle size<br /><br>* pharmacokinetics of EE, GSD and SHBG in treatment cycle 2 and 3</p><br>