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Russia/Ukraine Suppression of Ovarian Activity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550977
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Gestodene/EE Patch (BAY86-5016) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 18, 2015
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : August 15, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550977


Locations
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Russian Federation
Irkutsk, Russian Federation, 664003
Krasnodar, Russian Federation, 350063
Moscow, Russian Federation, 115280
Smolensk, Russian Federation, 214019
St. Petersburg, Russian Federation, 197374
St. Petersburg, Russian Federation, 199034
Ukraine
Kiev, Ukraine, 04050
Zaporizhzhya, Ukraine, 69068
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02550977     History of Changes
Other Study ID Numbers: 16119
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Contraception
Transdermal contraceptive patch
Safety
Efficacy
Pharmacokinetic
Additional relevant MeSH terms:
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Gestodene
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Progestins