Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 wome

Phase 3

Completed

• Conditions: cyclecontrol; cycluscontrole tijdens anticonceptie gebruik; bleedingpattern

• Registration Number: NL-OMON33166
• Lead Sponsor: Bayer Health Care AG

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: 140

Inclusion Criteria

1. Signed and dated informed consent
2. Healthy woman requesting contraception
3. Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
4. Normal cervical smear not requiring further follow-up
5. History of regular cyclic menstrual periods

Exclusion Criteria

Pregnancy or lactation, obesity (BMI> 30.0 kg/m2), hypersensitivity to any ingredient of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/ accumulation/ metabolism/ excretion of the study drug), any diseases/ conditions that may worsen under hormonal treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to investigate the bleeding pattern and cycle control<br /><br>parameters of the transdermal contraceptive patch (material no. 80876395, FC<br /><br>Patch Low containing 0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch<br /><br>(containing 0.6 mg EE and 6 mg NGMN). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are the contraceptive efficacy, safety profile<br /><br>(including lipid/carbohydrate metabolism) and population pharmacokinetics of FC<br /><br>Patch Low in comparison to the EVRA patch. Additionally, compliance and<br /><br>subjective assessment of the treatment will be evaluated.</p><br>