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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Organon

Information provided by (Responsible Party):

Carolyn L. Westhoff, Columbia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pharmacokinetics	Drug: NuvaRing	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Official Title:	Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®
Study Start Date :	June 2008
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight Hormones

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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 / 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.	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.

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710606

Locations

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United States, New York
Division of Family Planning and Preventive Services
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Organon

Investigators

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Principal Investigator:	Carolyn Westhoff, MD, MSc	Columbia University

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. doi: 10.1016/s0010-7824(95)00141-7.

Sivin I, Lahteenmaki 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. doi: 10.1016/s0010-7824(97)00153-4.

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. doi: 10.1016/s0010-7824(01)00226-8.

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. doi: 10.1016/s0029-7844(01)01534-4.

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. doi: 10.1016/s0015-0282(01)03275-7.

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Responsible Party:	Carolyn L. Westhoff, Director of Family Planning and Preventive Services Division, Columbia University
ClinicalTrials.gov Identifier:	NCT00710606
Other Study ID Numbers:	AAAC8127
First Posted:	July 4, 2008 Key Record Dates
Results First Posted:	April 30, 2015
Last Update Posted:	April 30, 2015
Last Verified:	April 2015

Keywords provided by Carolyn L. Westhoff, Columbia University:


contraceptive ring obesity pharmacokinetics pharmacodynamics Pharmacokinetics of the contraceptive ring in obese women.

Additional relevant MeSH terms:

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NuvaRing Ethinyl Estradiol Desogestrel Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Hormonal	Contraceptives, Oral Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Progestins

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