Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

Completed · Phase 4

Conditions studied: Obesity

In brief

Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the LNG aspect of the study procedures.

Key facts

Study ID

NCT02863445

Run by

Oregon Health and Science University

People needed

70

Starts

2017-07-06

Expected to finish

2021-08-16

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Generally health women
• Aged 18-35 years old
• Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater.
• Subjects must have a BMI of >30 kg/m2 and weigh at least 80 kg or more.

You may not qualify if…

• 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 (within last 8 weeks) use of hormonal contraception
• Current use of drugs that interfere with metabolism of sex steroids
• Smokers.

Where it is running

• OHSU — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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