Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®

This study has been completed.
Sponsor:
Collaborator:
Anonymous
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00710606
First received: July 1, 2008
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women.

Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women.

This investigation will focus on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study is a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We will recruit forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We will compare mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers include sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translate to understanding contraceptive-mediated suppression of ovarian function in these two groups. We will also have subjects log patterns of ring use and bleeding patterns during the study period.


Condition Intervention
Pharmacokinetics
Drug: NuvaRing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Mean serum concentrations of etonogestrel and ethyinyl estradiol over 6 weeks [ Time Frame: Measurements will be taken twice weekly during four weeks of continuous ring use ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean ovarian follicular development by week [ Time Frame: Transvaginal ultrasound measurements of ovarian follicular development will be completed twice weekly during four weeks of continuous ring use ] [ Designated as safety issue: No ]
  • Mean endometrial proliferation by week [ Time Frame: Transvaginal ultrasound measurements of endometrial proliferation will be completed twice weekly during four weeks of continuous ring use ] [ Designated as safety issue: No ]
  • Compare ovarian suppression in oral contraceptive users and Nuvaring users [ Time Frame: Transvaginal ultrasound measurements and serum hormone measurements taken twice a week for 6 weeks on Nuvaring and Twice a week for 4 weeks on COCs. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Obese subjects (BMI 30-39.9)
Drug: NuvaRing
Obese subjects (BMI 30-39.9) will receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
Active Comparator: 2
Normal weight subjects (BMI 19-24.9)
Drug: NuvaRing
Normal weight subjects will also receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.

  Eligibility

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

Inclusion Criteria:

  • 18-35 yo
  • Meet BMI requirements
  • Weight stable
  • English speaking
  • Desire contraception
  • History of regular menses with normal uterus and ovaries
  • Medically eligible for combined hormonal contraception
  • Tolerates phlebotomy/TVS

Exclusion Criteria:

  • Exclusion:
  • Heavy smokers
  • Users of medications that alter hormone levels
  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: NCT00710606

Locations
United States, New York
Division of Family Planning and Preventive Services
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Anonymous
Investigators
Principal Investigator: Monica Dragoman, MD Columbia University
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
  More Information

Publications:
Responsible Party: Monica Dragoman, MD, Columbia University Medical Center
ClinicalTrials.gov Identifier: NCT00710606     History of Changes
Other Study ID Numbers: AAAC8127
Study First Received: July 1, 2008
Last Updated: February 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
contraceptive ring
obesity
pharmacokinetics
pharmacodynamics
Pharmacokinetics of the contraceptive ring in obese women.

Additional relevant MeSH terms:
Contraceptive Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014