The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant
| Status: | Recruiting |
|---|---|
| Conditions: | Contraception, Contraception, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/3/2014 |
| Start Date: | December 2012 |
The Effect of Body Mass Index on Etonogestrel 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. 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.
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.
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.
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.
Inclusion Criteria:
- Woman using contraceptive implant for more than 12 months
- English or Spanish-speaking
Exclusion Criteria:
- None
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