Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

Phase 2

Completed

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

• Registration Number: NCT01204190
• Lead Sponsor: Bayer

Brief Summary

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.

With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy female volunteers
• age 18 - 35 years (smoker not older than 30 years, inclusive)
• ovulatory pre-treatment cycle

Exclusion Criteria

• Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
• Regular intake of medication other than Oral Contraception
• Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Gestodene/EE Patch (BAY86-5016)	-
Arm 2	Gestodene/EE Patch (BAY86-5016)	-
Arm 3	Gestodene/EE Patch (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
Hoogland score to evaluate the inhibition of ovulation	After 2 months

Secondary Outcome Measures

Name	Time	Method
Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone	After 2 months
Follicle size measured by transvaginal ultrasound examination	After 2 months
Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)	After 2 months