drugset / Trial / NCT02863445
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - LNG
Phase 4
Completed
70 enrolled
Oregon Health and Science University
National Institutes of Health (NIH) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-07-06
- Primary completion
- 2021-01-16
- Completion
- 2021-08-16
Publications
- Background Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.
- Results Edelman AB, Hennebold JD, Bond K, Lim JY, Cherala G, Archer DF, Jensen JT. Double Dosing Levonorgestrel-Based Emergency Contraception for Individuals With Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jul 1;140(1):48-54. doi: 10.1097/AOG.0000000000004717. Epub 2022 Jun 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levonorgestrel | Small molecule | 1.5 mg | Oral |
| Comparator | Levonorgestrel | Small molecule | 3 mg | Oral |