Emergency Contraception and Body Weight: Pilot Study

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Contraception; Body Weight

Treatments: Drug: ECx1; Drug: ECx2

Study type: Interventional

Funder types: Other

Identifiers

NCT02408692

OHSU IRB 11419

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Normal BMI ECx1

Active Comparator group

Description:

5 normal weight women (BMI\<25 kg/m2) taking 1.5mg LNG

Treatment:

Drug: ECx1

Obese BMI ECx1

Active Comparator group

Description:

5 obese women (BMI \>30 kg/m2) taking 1.5mg LNG

Treatment:

Drug: ECx1

Obese BMI ECx2

Active Comparator group

Description:

5 obese women (BMI \>30 kg/m2) taking 3mg LNG

Treatment:

Drug: ECx2