Russia/Ukraine Suppression of Ovarian Activity Study

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550977
• Other study ID #: 16119
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2015
• Last updated: August 4, 2017
• Start date: September 18, 2015
• Est. completion date: August 15, 2016

Study information

• Verified date: July 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 15, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Gestodene/EE Patch (BAY86-5016)
7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

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

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