Inhibition of Ovulation, Patch, Ethinylestradiol and Gestodene

Phase 2

Terminated

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

• Registration Number: NCT00729404
• 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

Study was suspended due to inconclusive toxicology findings regarding the used patch formulation to be clarified prior to re-start of the study.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Signed informed consent,
• BMI: 18 - 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/arterial 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 month

Secondary Outcome Measures

Name	Time	Method
Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)	4 month
Follicle size	4 month
Course of gonadotropins (FSH, LH, P, E2)	4 month
Endometrial thickness	4 month
Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3	4 month