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

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ClinicalTrials.gov Identifier: NCT00710606
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
Organon
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

Tracking Information
First Submitted Date  ICMJE July 1, 2008
First Posted Date  ICMJE July 4, 2008
Results First Submitted Date  ICMJE August 22, 2013
Results First Posted Date  ICMJE April 30, 2015
Last Update Posted Date April 30, 2015
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol [ Time Frame: Measurements at Week 3 and Week 6 continuous ring use ]
Serum concentrations were obtained from thirty-seven women completed follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Mean serum concentrations of etonogestrel and ethyinyl estradiol [ Time Frame: Measurements will be taken twice weekly during four weeks of continuous ring use ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up [ Time Frame: continuous ring use, an average of 3 weeks ]
    Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).
  • Mean Endometrial Proliferation [ Time Frame: Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks ]
    The mean endometrial proliferation from week 1, week 2 and week3
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®
Official Title  ICMJE Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®
Brief Summary

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 focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was 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 recruited 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 compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included 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 translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: 1- Obese Women /Nuvaring
    Obese subjects (BMI 30-39.9)received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
    Intervention: Drug: NuvaRing
  • Active Comparator: 2- Normal Weight / Nuvaring
    Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
    Intervention: Drug: NuvaRing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00710606
Other Study ID Numbers  ICMJE AAAC8127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolyn L. Westhoff, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Organon
Investigators  ICMJE
Principal Investigator: Carolyn Westhoff, MD, MSc Columbia University
PRS Account Columbia University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP