Emergency Contraception and Body Weight: Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception, Obesity Weight Loss, Hospital |
| Therapuetic Areas: | Endocrinology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 10/27/2017 |
| Start Date: | February 2015 |
| End Date: | August 2015 |
The purpose of this research study is to determine how body weight changes the drug level of
an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This
emergency contraceptive is available to women without a prescription, but has recently been
found to not work as well to prevent pregnancies in women of higher body weight. The overall
goal of this research is to improve the effectiveness of contraception for women, no matter
their weight.
an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This
emergency contraceptive is available to women without a prescription, but has recently been
found to not work as well to prevent pregnancies in women of higher body weight. The overall
goal of this research is to improve the effectiveness of contraception for women, no matter
their weight.
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based
emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test
whether doubling the dose of LNG-EC in obese women increases total and free LNG serum
concentrations.
We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG
orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG.
Total and free LNG PK parameters were obtained via serum samples through an indwelling
catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and
free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test
whether doubling the dose of LNG-EC in obese women increases total and free LNG serum
concentrations.
We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG
orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG.
Total and free LNG PK parameters were obtained via serum samples through an indwelling
catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and
free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
Inclusion Criteria:
- Subjects are between the ages of 18 and 35
- Subjects are in good general health
- Subjects have regular menstrual cycles (between 21 and 35 days)
- Subjects are willing to use condoms (if you are sexually active with a male partner),
subjects are willing to not have sex with men during the study, or subjects have had a
tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper
intrauterine device (IUD).
Exclusion Criteria:
- Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian
Syndrome
- Impaired liver or renal function
- Actively seeking or involved in a weight loss program (must be weight stable)
- Pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal
contraception
- Current use of drugs that interfere with metabolism of sex steroids
- Smokers.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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