US Ovulation Inhibition Study in Obese Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00873483
First received: March 31, 2009
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

Birth Control Patch Study


Condition Intervention Phase
Contraception
Drug: Ethinylestradiol/Gestodene (BAY86-5016)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Determination of Hoogland Scores [ Time Frame: Treatment Cycles 2 & 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory values for E2, progesterone, FSH and LH [ Time Frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3 ] [ Designated as safety issue: No ]
  • Endometrial thickness [ Time Frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3 ] [ Designated as safety issue: No ]
  • Follicle size [ Time Frame: Pretreatment & regularly during Treatment Cycles 1, 2, 3 ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Ethinylestradiol/Gestodene (BAY86-5016)
0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873483

Locations
United States, Arizona
Tucson, Arizona, United States, 85712
United States, California
San Diego, California, United States, 92108
United States, Georgia
Sandy Springs, Georgia, United States, 30328
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19114
United States, Texas
Houston, Texas, United States, 77054
United States, Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00873483     History of Changes
Other Study ID Numbers: 13871
Study First Received: March 31, 2009
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Pregnancy prevention
female contraception
patch

Additional relevant MeSH terms:
Ethinyl Estradiol
Femovan
Gestodene
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014