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NCT01855620 · ClinicalTrials.gov registry record
The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 52
- Enrollment target
NCT01855620: Completed study, sponsored by Columbia University.
NCT01855620 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01855620 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-03 |
What the finished NCT01855620 record still lists
NCT01855620 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01855620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01855620 about?
NCT01855620 is a clinical study titled "The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant". 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. Metho...
What is the current status of trial NCT01855620?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2012-12. Estimated completion is 2014-03.
Who is sponsoring clinical trial NCT01855620?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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