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

Condition(s) targeted: Pharmacokinetics

Intervention: NuvaRing (Drug); NuvaRing (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Monica Dragoman, MD, Principal Investigator, Affiliation: Columbia University Medical Center
Carolyn Westhoff, MD, MSc, Principal Investigator, Affiliation: Columbia University Medical Center

Overall contact:
Monica V Dragoman, MD, Phone: 212-305-4938, Email: mvd2116@columbia.edu

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 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.

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

Study design: Other, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: Mean serum concentrations of etonogestrel and ethyinyl estradiol

Secondary outcome:

Mean ovarian follicular development by week

Mean endometrial proliferation by week

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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

Monica V Dragoman, MD, Phone: 212-305-4938, Email: mvd2116@columbia.edu

Division of Family Planning and Preventive Services, New York, New York 10032, United States; Recruiting
Monica Dragoman, MD, Principal Investigator
Carolyn Westhoff, MD, MSc, Principal Investigator

Related 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.

Starting date: June 2008
Ending date: October 2008
Last updated: July 3, 2008