Multicenter, open-label, randomized, uncontrolled 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 - Inhibition of ovulation, patch, ethinylestradiol and gestodene

• Conditions: The trial will be performed in healthy female volunteers. The indended indication is female contraception.

• Registration Number: EUCTR2008-001198-13-DE
• Lead Sponsor: Bayer HealthCare AG/Bayer Schering Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-24
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Signed informed consent prior to study participation and confirmation of the volunteer’s health insurance coverage
Healthy female volunteer
Age: 18 – 35 years (inclusive) at the first screening examination
Body mass index (BMI): 18 = BMI = 30 kg/m²
At least 3 months since delivery, abortion, or lactation before the first screening examination
Willingness to use non-hormonal methods of contraception during the entire study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Contraindications for use of a combined (estrogen/progestogen) contraception (e.g. History of venous/arterial thromembolic disease)
regular intake of medication other than OCs
Clinically relevant findings (ECG, blood preasure, physical, gynecological examination, laboratory examination)
Anovulatory pre-treatment cycle
Skin diseases with suspected alteration of dermal resorption and / or increased risk for dermal intolerance (e.g. psoriasis, neurodermitis, urticaria)
Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 after administration of two different patches containing EE and GSD for 3 treatment cycles.;Secondary Objective: The following evaluations represent the secondary objectives:<br>Assessment of ovarian activity in treatment cycles 2 and 3 (Hoogland Score)<br>Course of gonadotropins (FSH, LH), progesterone and E2<br>Endometrial thickness<br>Follicle size<br>Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3<br>;Primary end point(s): The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation” (i.e. Hoogland score 6) with the levels yes” and no”.