Emergency Contraception and Body Weight: Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Emergency Contraception and Body Weight: Pilot Study

Conditions
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Contraception, Body Weight

Intervention / Treatment
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* Drug: ECx1
* Drug: ECx2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal BMI ECx1<br>5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG | Drug: ECx1<br>* At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.<br>* Other names: Emergency Contraception;|
| Active Comparator: Obese BMI ECx1<br>5 obese women (BMI >30 kg/m2) taking 1.5mg LNG | Drug: ECx1<br>* At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.<br>* Other names: Emergency Contraception;|
| Active Comparator: Obese BMI ECx2<br>5 obese women (BMI >30 kg/m2) taking 3mg LNG | Drug: ECx2<br>* At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)<br>* Other names: Emergency Contraception;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel | Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel | Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel | Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel | Follicular phase of menstrual cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency contraception, Obese BMI, Normal BMI