Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

Phase 4 Terminated 532 enrolled Kimberly Myer Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

The proposed research study is a Phase IIb, multi-center, single-blind, randomized study of UPA 30 mg, LNG 1.5 mg and LNG 3.0 mg to evaluate EC effectiveness in women with weight ≥ 80 kg who present within 72 hours of unprotected intercourse.

Timeline

Start: 2018-07-12
Primary completion: 2022-04-20
Completion: 2022-04-20

Publications

Edelman A, Jensen JT, Brown J, Thomas M, Archer DF, Schreiber CA, Teal S, Westhoff C, Dart C, Blithe DL. Emergency contraception for individuals weighing 80 kg or greater: A randomized trial of 30 mg ulipristal acetate and 1.5 mg or 3.0 mg levonorgestrel. Contraception. 2024 Sep;137:110474. doi: 10.1016/j.contraception.2024.110474. Epub 2024 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Levonorgestrel	Small molecule	1.5 mg	Oral
Comparator	Levonorgestrel	Small molecule	3 mg	Oral
Comparator	Ulipristal Acetate	Unknown	30 mg	Oral

Indications

No indication recorded.