check_circleStudy Completed

Contraception

Bayer Identifier:
16119
ClinicalTrials.gov Identifier:
NCT02550977
EudraCT Number:
Not Available
EU CT Number:
Not Available
Russia/Ukraine Suppression of Ovarian Activity Study

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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
September 2015 - August 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kiev, 04050, Ukraine
Completed
Kiev, 04050, Ukraine
Completed
St. Petersburg, 199034, Russia
Completed
Krasnodar, 350063, Russia
Completed
Irkutsk, 664003, Russia
Completed
St. Petersburg, 197374, Russia
Completed
Moscow, 115280, Russia
Completed
Smolensk, 214019, Russia
Completed
Zaporizhzhya, 69068, Ukraine

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Treatment day 29 to day 84
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Serum concentration, AUC (area under curve) of Gestodene
    date_rangeTime Frame:
    Multiple time points up to treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Serum concentration, AUC (area under curve) of ethinyl estradiol
    date_rangeTime Frame:
    Multiple time points up to treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Serum concentration, AUC (area under curve) of Sexual hormone binding globulin
    date_rangeTime Frame:
    Multiple time points up to treatment day 84
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with adverse events
    date_rangeTime Frame:
    Up to 84 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with abnormal safety laboratory
    date_rangeTime Frame:
    Up to 84 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Time course of follicle-stimulating hormone
    Serum concentration of follicle-stimulating hormone (FSH)
    date_rangeTime Frame:
    Day 27 of pretreatment cycle to treatment day 83
  • Time course of luteinizing hormone
    Serum concentration of luteinizing hormone (LH)
    date_rangeTime Frame:
    Day 27 of pretreatment cycle to treatment day 83

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

Additional Information

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