Trial Condition(s):
Contraception
Russia/Ukraine Suppression of Ovarian Activity Study
Bayer Identifier:
16119
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Kiev, Ukraine, 04050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 199034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krasnodar, Russia, 350063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Irkutsk, Russia, 664003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197374 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 115280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Smolensk, Russia, 214019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zaporizhzhya, Ukraine, 69068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Suppression of ovulatory activity proved by progesterone and estradiol concentrationsEstradiol 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.Timeframe: Treatment day 29 to day 84
Secondary Outcome
- Serum concentration, AUC (area under curve) of GestodeneTimeframe: Multiple time points up to treatment day 84
- Serum concentration, AUC (area under curve) of ethinyl estradiolTimeframe: Multiple time points up to treatment day 84
- Serum concentration, AUC (area under curve) of Sexual hormone binding globulinTimeframe: Multiple time points up to treatment day 84
- Number of patients with adverse eventsTimeframe: Up to 84 days
- Number of patients with abnormal safety laboratoryTimeframe: Up to 84 days
- Time course of follicle-stimulating hormoneSerum concentration of follicle-stimulating hormone (FSH)Timeframe: Day 27 of pretreatment cycle to treatment day 83
- Time course of luteinizing hormoneSerum concentration of luteinizing hormone (LH)Timeframe: Day 27 of pretreatment cycle to treatment day 83
Additional Information
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