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

NCT00710606 | Completed Results

• 1 other identifier: AAAC8127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol

  Serum concentrations were obtained from thirty-seven women completed follow-up.

  Measurements at Week 3 and Week 6 continuous ring use

Secondary Outcomes (2)

• Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up

  continuous ring use, an average of 3 weeks

• Mean Endometrial Proliferation

  Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks

Study Arms (2)

1- Obese Women /Nuvaring

EXPERIMENTAL

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

2- Normal Weight / Nuvaring

ACTIVE COMPARATOR

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

Interventions

NuvaRing DRUG

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.

1- Obese Women /Nuvaring

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Heavy smokers
• Users of medications that alter hormone levels

Sponsors & Collaborators

• Columbia University: lead
• Organon: collaborator

Study Sites (1)

Division of Family Planning and Preventive Services

New York, New York, 10032, United States

Location

Related Publications (6)

• 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.

  PMID: 8536454 BACKGROUND

• 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.

  PMID: 9437561 BACKGROUND

• 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.

  PMID: 11535213 BACKGROUND

• 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.

  PMID: 11704172 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11849631 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

NuvaRing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carolyn Westhoff
• Organization: Columbia University

clw3@columbia.edu

212-305-4805

Study Officials

• Carolyn Westhoff, MD, MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Family Planning and Preventive Services Division

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 4, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)