Inhibition of Ovulation and Pharmacokinetics of Transdermal Ethinylestradiol (EE) and Gestodene (GSD)

Phase 2

Completed

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

• Registration Number: NCT00915915
• Lead Sponsor: Bayer

Brief Summary

Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-05-18
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

• BMI: 18 BMI 30 kg/m²
• Healthy female volunteers
• Age 18-35 years (smoker not older than 30 years, inclusive)
• Ovulatory pre-treatment cycle, at least 3 month since delivery
• Abortion or lactation before the first screening examination
• Willingness to use non-hormonal methods of contraception during entire study

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Exclusion Criteria

• Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous/artial thromboembolic disease
• Regular intake of medication other than OCs
• Clinically relevant findings (blood pressure, physical and gynaecological examination, laboratory examination) anovulatory pre-treatment cycle

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Ethinylestradiol/Gestodene (BAY86-5016)	-
Arm 2	Ethinylestradiol/Gestodene (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3	4 months

Secondary Outcome Measures

Name	Time	Method
The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3	4 months
Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3	4 Months
Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3	4 Months
Course of gonadotropins (FSH, LH, P, E2)	4 months
Endometrial thickness and Follicle size	4 months