Trial Condition(s):

Contraception

Russia/Ukraine Suppression of Ovarian Activity Study

Bayer Identifier:

16119

ClinicalTrials.gov Identifier:

NCT02550977

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
91
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kiev, Ukraine, 04050

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 199034

Status
Completed
 
Locations

Investigative Site

Krasnodar, Russia, 350063

Status
Completed
 
Locations

Investigative Site

Irkutsk, Russia, 664003

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 197374

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 115280

Status
Completed
 
Locations

Investigative Site

Smolensk, Russia, 214019

Status
Completed
 
Locations

Investigative Site

Zaporizhzhya, Ukraine, 69068

Status
Completed
 

Trial Design