Russia/Ukraine Suppression of Ovarian Activity Study

Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles

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 Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Gestodene/EE Patch (BAY86-5016)

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Irkutsk, Russian Federation, 664003
  • Krasnodar, Russian Federation, 350063
  • Moscow, Russian Federation, 115280
  • Smolensk, Russian Federation, 214019
  • St. Petersburg, Russian Federation, 199034
  • St. Petersburg, Russian Federation, 197374
• Ukraine
  • Kiev, Ukraine, 04050
  • Zaporizhzhya, Ukraine, 69068

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gestodene/EE Patch	Drug: Gestodene/EE Patch (BAY86-5016); 7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Treatment day 29 to day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration, AUC (area under curve) of Gestodene		Multiple time points up to treatment day 84
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
Number of patients with adverse events		Up to 84 days
Number of patients with abnormal safety laboratory		Up to 84 days
Time course of follicle-stimulating hormone	Serum concentration of follicle-stimulating hormone (FSH)	Day 27 of pretreatment cycle to treatment day 83
Time course of luteinizing hormone	Serum concentration of luteinizing hormone (LH)	Day 27 of pretreatment cycle to treatment day 83

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2015
• Primary Completion (Actual): July 15, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: August 4, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Contraception; Pharmacokinetic; Transdermal contraceptive patch
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Gestodene
• Other Study ID Numbers: 16119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No