Russia/Ukraine Suppression of Ovarian Activity Study

Phase 2

Completed

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

• Registration Number: NCT02550977
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to look into the effectiveness of a new investigational medication applied as a transdermal patch. The patch is applied on the skin with study medication that is absorbed through the skin suppressing ovarian activity and therefore preventing an egg from leaving an ovary (ovulation). The study will look into the study drug's safety and how well it is tolerated and its absorption, breakdown and elimination in the body. It describes how the body affects a specific drug after administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Study Start: 2015-09-18
• Primary Completion: 2016-07-15
• Study Completion: 2016-08-15
• Status Verified: 2017-07
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

• Healthy female subjects requesting contraception
• Aged 18 to 35 years (inclusive); smokers must not be older than 30 years
• Normal or clinically insignificant cervical smear not requiring further follow-up
• History of regular cyclic menstrual periods
• Willingness to use nonhormonal methods of contraception during the entire study
• Proven ovulation upon completion of the pretreatment cycle

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Exclusion Criteria

• Pregnancy or lactation
• Obesity (body mass index [BMI] > 30.0 kg/m2)
• Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
• Any disease or condition that may worsen under hormonal treatment
• Use of hormonal contraception other than study medication during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gestodene/EE Patch	Gestodene/EE Patch (BAY86-5016)	-

Primary Outcome Measures

Name	Time	Method
Suppression of ovulatory activity proved by progesterone and estradiol concentrations	Treatment day 29 to day 84	Estradiol levels \> 100pmol/L indicate some ovarian activity and progesterone levels \> 5nmol/L in subjects with estradiol levels \> 100pmol/L reflect ovulation or luteinized unruptured follicles.

Secondary Outcome Measures

Name	Time	Method
Serum concentration, AUC (area under curve) of Gestodene	Multiple time points up to treatment day 84
Number of patients with abnormal safety laboratory	Up to 84 days
Number of patients with adverse events	Up to 84 days
Time course of luteinizing hormone	Day 27 of pretreatment cycle to treatment day 83	Serum concentration of luteinizing hormone (LH)
Serum concentration, AUC (area under curve) of ethinyl estradiol	Multiple time points up to treatment day 84
Serum concentration, AUC (area under curve) of Sexual hormone binding globulin	Multiple time points up to treatment day 84
Time course of follicle-stimulating hormone	Day 27 of pretreatment cycle to treatment day 83	Serum concentration of follicle-stimulating hormone (FSH)