Emergency Contraception and Body Weight: Pilot Study

Phase 4

Completed

• Conditions: Contraception; Body Weight
• Interventions: Drug: ECx1; Drug: ECx2

• Registration Number: NCT02408692
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Results First Submitted: 2017-04-29
• Results First Submitted QC: 2017-04-29
• Results First Posted: 2017-06-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal BMI ECx1	ECx1	5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG
Obese BMI ECx1	ECx1	5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG
Obese BMI ECx2	ECx2	5 obese women (BMI \>30 kg/m2) taking 3mg LNG

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States