US Ovulation Inhibition Study in Obese Women

April 6, 2021 updated by: Bayer

Multicenter, Open-Label, Uncontrolled Study to Investigate the Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal Patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles

Birth Control Patch Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
    • California
      • San Diego, California, United States, 92108
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
    • Texas
      • Houston, Texas, United States, 77054
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female subject requesting contraception
  • Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
  • Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
  • History of regular cyclic menstrual periods
  • Willingness to use non-hormonal methods of contraception during the entire study.

Exclusion Criteria:

  • Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
  • Hypersensitivity to any ingredient of the study drug
  • Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
  • Any disease or condition that may worsen under hormonal treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Ethinylestradiol/Gestodene (BAY86-5016)
0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of Hoogland Scores
Time Frame: Treatment Cycles 2 & 3
Treatment Cycles 2 & 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Laboratory values for E2, progesterone, FSH and LH
Time Frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Pretreatment & regularly during Treatment Cycles 1, 2, 3
Endometrial thickness
Time Frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Pretreatment & regularly during Treatment Cycles 1, 2, 3
Follicle size
Time Frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3
Pretreatment & regularly during Treatment Cycles 1, 2, 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2009

Primary Completion (ACTUAL)

March 3, 2010

Study Completion (ACTUAL)

March 3, 2010

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (ESTIMATE)

April 1, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13871

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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