Russia/Ukraine Suppression of Ovarian Activity Study

NCT02550977 | Completed Phase 2

• 1 other identifier: 16119
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 8

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.

Conditions

Contraception

Keywords

Contraception; Transdermal contraceptive patch; Safety; Efficacy; Pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Gestodene/EE Patch

EXPERIMENTAL

Drug: Gestodene/EE Patch (BAY86-5016)

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.

Gestodene/EE Patch

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Unknown Facility

Irkutsk, 664003, Russia

Location

Unknown Facility

Krasnodar, 350063, Russia

Location

Unknown Facility

Moscow, 115280, Russia

Location

Unknown Facility

Saint Petersburg, 197374, Russia

Location

Unknown Facility

Saint Petersburg, 199034, Russia

Location

Unknown Facility

Smolensk, 214019, Russia

Location

Unknown Facility

Kiev, 04050, Ukraine

Location

Unknown Facility

Zaporizhzhya, 69068, Ukraine

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 16, 2015
• Study Start: September 18, 2015
• Primary Completion: July 15, 2016
• Study Completion: August 15, 2016
• Last Updated: August 7, 2017

Record last verified: 2017-07

Locations

UA (2); RU (6)