Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing® - Full Text View

Sponsors and Collaborators:	Columbia University An anonymous Foundation.
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00710606

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:	Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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
1: Experimental 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.
2: Active Comparator 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

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

An anonymous Foundation.

Investigators

Principal Investigator:	Monica Dragoman, MD	Columbia University Medical Center
Principal Investigator:	Carolyn Westhoff, MD, MSc	Columbia University Medical Center

More Information

Publications:

Gu S, Sivin I, Du M, Zhang L, Ying L, Meng F, Wu S, Wang P, Gao Y, He X, et al. Effectiveness of Norplant implants through seven years: a large-scale study in China. Contraception. 1995 Aug;52(2):99-103.

Sivin I, Lähteenmäki P, Mishell DR Jr, Alvarez F, Diaz S, Ranta S, Grozinger C, Lacarra M, Brache V, Pavez M, Nash H, Stern J. First week drug concentrations in women with levonorgestrel rod or Norplant capsule implants. Contraception. 1997 Nov;56(5):317-21.

Sivin I, Wan L, Ranta S, Alvarez F, Brache V, Mishell DR Jr, Darney P, Biswas A, Diaz S, Kiriwat O, Anant MP, Klaisle C, Pavez M, Schechter J. Levonorgestrel concentrations during 7 years of continuous use of Jadelle contraceptive implants. Contraception. 2001 Jul;64(1):43-9.

Smallwood GH, Meador ML, Lenihan JP, Shangold GA, Fisher AC, Creasy GW; ORTHO EVRA/EVRA 002 Study Group. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol. 2001 Nov;98(5 Pt 1):799-805.

Westhoff, C. Higher body weight does not affect NuvaRing's efficacy. Obstet Gynecol 2005; 104: 56S.

Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002 Feb;77(2 Suppl 2):S13-8.

Responsible Party:	Columbia University Medical Center ( Monica Dragoman, MD )
Study ID Numbers:	AAAC8127
Study First Received:	July 1, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00710606 History of Changes
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.

Study placed in the following topic categories:

Body Weight
Obesity
Contraceptive Agents

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009