Clinical trial NCT01855620: The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant
Official title: The Effect of Body Mass Index on Etonogestrel Levels in Women Using the Single-rod Contraceptive Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Obesity
Keywords: Contraception
Implant
Obesity
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Serum Etonogestrel Level
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Kathleen M Morrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Morrell KM, Cremers S, Westhoff CL, Davis AR. Relationship between etonogestrel level and BMI in women using the contraceptive implant for more than 1 year. Contraception. 2016 Mar;93(3):263-5. doi: 10.1016/j.contraception.2015.11.005. Epub 2015 Nov 11.