Russia/Ukraine Suppression of Ovarian Activity Study

Bayer91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Contraception

Interventions

Gestodene/EE Patch (BAY86-5016)DRUG

7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Locations (8)

Unnamed facility

Irkutsk, Russia

Unnamed facility

Krasnodar, Russia

Unnamed facility

Moscow, Russia

Unnamed facility

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Suppression of ovulatory activity proved by progesterone and estradiol concentrations

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.

Time frame: Treatment day 29 to day 84

Secondary Outcomes

Serum concentration, AUC (area under curve) of Gestodene

Time frame: Multiple time points up to treatment day 84

Serum concentration, AUC (area under curve) of ethinyl estradiol

Time frame: Multiple time points up to treatment day 84

Serum concentration, AUC (area under curve) of Sexual hormone binding globulin

Time frame: Multiple time points up to treatment day 84

Number of patients with adverse events

Time frame: Up to 84 days

Number of patients with abnormal safety laboratory

Time frame: Up to 84 days

Time course of follicle-stimulating hormone

Serum concentration of follicle-stimulating hormone (FSH)

Time frame: Day 27 of pretreatment cycle to treatment day 83

Time course of luteinizing hormone

Serum concentration of luteinizing hormone (LH)

Time frame: Day 27 of pretreatment cycle to treatment day 83

Data from ClinicalTrials.gov

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