The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant (Eto BMI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen M. Morrell, Columbia University
ClinicalTrials.gov Identifier:
NCT01855620
First received: May 14, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

Two-thirds of young women in the United States are overweight or obese. This excess weight may affect how their body metabolizes drugs such as different birth control methods. There is a not a lot of research about how excess weight could affect the hormone levels of the contraceptive implant. Methods like the implant contain only progesterone, which is a hormone that does not increase a woman's risk of blood clot. These methods would be preferred for overweight and obese women because excess weight also increases a woman's risk of blood clot.

The investigators propose a study comparing blood hormone levels of women using the implant for at least twelve months and in all weight categories. The investigators hope to show that all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.


Condition
Contraception
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Body Mass Index on Etonogestrel Levels in Women Using the Single-rod Contraceptive Implant

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Serum Etonogestrel Level [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The investigators will measure the serum levels of etonogestrel in normal weight (BMI < 25kg/m2), overweight (BMI ≥ 25kg/m2 and < 30kg/m2), and obese women (BMI ≥ 30kg/m2) using the single-rod contraceptive implant for at least twelve months. The primary objective is to compare the three groups and to evaluate whether etonogestrel levels fall below the critical level for contraceptive efficacy (90 pg/mL) (Díaz 1991) in any group.


Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 52
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal weight women
Women with implant for more than twelve months who have BMI <25.
Overweight women
Women with implant for more than twelve months who have BMI > or = 25 and <30.
Obese women
Women with implant for more than twelve months who have BMI > or = 30.

Detailed Description:

Two-thirds of reproductive-age women in the United States are either overweight or obese. Body composition may affect contraceptive hormone metabolism and possibly efficacy. Phase III studies to date included few women weighing more than 70 kilograms (134 of 923, 14.5%); there were no reported pregnancies in that group. Data about pregnancy rates for women in higher body mass index (BMI) categories using the etonogestrel implant exists, but we know little about how weight affects the serum etonogestrel levels. Progestin-only methods, such as the etonogestrel implant, may be preferred over combined methods including estrogens because obesity increases thrombosis risk.

The investigators propose a prospective study to compare serum etonogestrel levels in the second and third years of implant use between women across body mass index categories.

Based on previous studies, the investigators expect a difference in etonogestrel levels based on body weight; however, the investigators hypothesize that etonogestrel levels will remain above the threshold for ovulation suppression through three years of implant use for women across BMI categories.

The investigators will measure the serum levels of etonogestrel in normal weight (BMI < 25kg/m2), overweight (BMI ≥ 25kg/m2 and < 30kg/m2), and obese women (BMI ≥ 30kg/m2) using the single-rod contraceptive implant for at least twelve months. Their primary objective is to compare the three groups and to evaluate whether etonogestrel levels fall below the critical level for contraceptive efficacy (90 pg/mL) (Díaz 1991) in any group.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population is English or Spanish-speaking women ages 15-45 years old at the New York Presbyterian Hospital's Title X Family Planning Clinic and the Columbia University Medical Center's Department of Obstetrics and Gynecology Family Planning Practice who have been using the etonogestrel contraceptive implant for at least the six months prior to their visit.

Criteria

Inclusion Criteria:

  • Woman using contraceptive implant for more than 12 months
  • English or Spanish-speaking

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855620

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Kathleen M Morrell, MD Columbia University
  More Information

Additional Information:
Publications:

Responsible Party: Kathleen M. Morrell, Assistant Professor of Clinical Obgyn, Columbia University
ClinicalTrials.gov Identifier: NCT01855620     History of Changes
Other Study ID Numbers: AAAK6606
Study First Received: May 14, 2013
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Contraception
Implant
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014