Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Aug 8, 2016

Keywords

ClinConnect Summary

Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.

The PI's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy...

Gender

FEMALE

Eligibility criteria

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