Clinical trial NCT02550977: Russia/Ukraine Suppression of Ovarian Activity Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Contraception
Transdermal contraceptive patch
Safety
Efficacy
Pharmacokinetic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Suppression of ovulatory activity proved by progesterone and estradiol concentrations
timeFrame: Treatment day 29 to day 84
Secondary outcomes:
measure: Serum concentration, AUC (area under curve) of Gestodene
timeFrame: Multiple time points up to treatment day 84
measure: Serum concentration, AUC (area under curve) of ethinyl estradiol
timeFrame: Multiple time points up to treatment day 84
measure: Serum concentration, AUC (area under curve) of Sexual hormone binding globulin
timeFrame: Multiple time points up to treatment day 84
measure: Number of patients with adverse events
timeFrame: Up to 84 days
measure: Number of patients with abnormal safety laboratory
timeFrame: Up to 84 days
measure: Time course of follicle-stimulating hormone
timeFrame: Day 27 of pretreatment cycle to treatment day 83
measure: Time course of luteinizing hormone
timeFrame: Day 27 of pretreatment cycle to treatment day 83
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Kiev
country: Ukraine
city: Zaporizhzhya
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: