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OpenTrials
Completed

NCT Number: NCT00873483

US Ovulation Inhibition Study in Obese Women

Birth Control Patch Study

Completed

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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

Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Ethinylestradiol/Gestodene (BAY86-5016)

Drug

0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles

Primary outcomes

  1. Determination of Hoogland Scores

    Time frame: Treatment Cycles 2 & 3

Secondary outcomes

  1. Laboratory values for E2, progesterone, FSH and LH

    Time frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3

  2. Endometrial thickness

    Time frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3

  3. Follicle size

    Time frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2009
Registry last updated
Apr 8, 2021

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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