US Ovulation Inhibition Study in Obese Women

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: Ethinylestradiol/Gestodene (BAY86-5016)

• Registration Number: NCT00873483
• Lead Sponsor: Bayer

Brief Summary

Birth Control Patch Study

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Study Start: 2009-04-30
• Primary Completion: 2010-03-03
• Study Completion: 2010-03-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 173

Inclusion Criteria

• Female subject requesting contraception
• Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
• Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
• History of regular cyclic menstrual periods
• Willingness to use non-hormonal methods of contraception during the entire study.

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Exclusion Criteria

• Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
• Hypersensitivity to any ingredient of the study drug
• Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
• Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
• Any disease or condition that may worsen under hormonal treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Ethinylestradiol/Gestodene (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
Determination of Hoogland Scores	Treatment Cycles 2 & 3

Secondary Outcome Measures

Name	Time	Method
Laboratory values for E2, progesterone, FSH and LH	Pretreatment & regularly during Treatment Cycles 1, 2, 3
Follicle size	Pretreatment & regularly during Treatment Cycles 1, 2, 3
Endometrial thickness	Pretreatment & regularly during Treatment Cycles 1, 2, 3