At a glance
ClinicalIndex Comparison Record- ✓Healthy women aged 18–35 years
- ✓Regular menstrual cycles every 21–35 days with documented ovulatory cycle (progesterone ≥3 ng/mL)
- ✓Obese: BMI >30 kg/m² and weight ≥80 kg
- ✕Metabolic disorders including uncontrolled thyroid dysfunction and polycystic ovary syndrome
- ✕Impaired liver or renal function
- ✕Active weight loss program or weight instability
- ✕Pregnancy, breastfeeding, or desire to become pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - Pharmacodynamics of 3.0mg LNG
In Brief
A Phase 4 clinical trial evaluating Levonorgestrel-based emergency contraception 1.5 mg and Levonorgestrel-based emergency contraception 3.0mg for Obesity. Completed, enrolled 70 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC