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Completed

NCT Number: NCT02550977

Russia/Ukraine Suppression of Ovarian Activity Study

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.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Irkutsk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gestodene/EE Patch (BAY86-5016)

Drug

7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.

Primary outcomes

  1. Suppression of ovulatory activity proved by progesterone and estradiol concentrations

    Time frame: Treatment day 29 to day 84

    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.

Secondary outcomes

  1. Serum concentration, AUC (area under curve) of Gestodene

    Time frame: Multiple time points up to treatment day 84

  2. Serum concentration, AUC (area under curve) of ethinyl estradiol

    Time frame: Multiple time points up to treatment day 84

  3. Serum concentration, AUC (area under curve) of Sexual hormone binding globulin

    Time frame: Multiple time points up to treatment day 84

  4. Number of patients with adverse events

    Time frame: Up to 84 days

  5. Number of patients with abnormal safety laboratory

    Time frame: Up to 84 days

  6. Time course of follicle-stimulating hormone

    Time frame: Day 27 of pretreatment cycle to treatment day 83

    Serum concentration of follicle-stimulating hormone (FSH)

  7. Time course of luteinizing hormone

    Time frame: Day 27 of pretreatment cycle to treatment day 83

    Serum concentration of luteinizing hormone (LH)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2015
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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