US Ovulation Inhibition Study in Obese Women

Study Overview
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Brief Summary
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Birth Control Patch Study

Official Title
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Multicenter, Open-Label, Uncontrolled Study to Investigate the Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal Patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles

Conditions
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Contraception

Intervention / Treatment
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* Drug: Ethinylestradiol/Gestodene (BAY86-5016)


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ethinylestradiol/Gestodene (BAY86-5016)<br>* 0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Hoogland Scores |  | Treatment Cycles 2 & 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory values for E2, progesterone, FSH and LH |  | Pretreatment & regularly during Treatment Cycles 1, 2, 3 | 
| Endometrial thickness |  | Pretreatment & regularly during Treatment Cycles 1, 2, 3 | 
| Follicle size |  | Pretreatment & regularly during Treatment Cycles 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy prevention, female contraception, patch