drugset / Trial / NCT04948489

IUD and Norethindrone Acetate for Treatment of Endometriosis

NCT04948489

Phase 2 Withdrawn Boston Children's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Endometriosis is the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. The levonorgestrel-containing IUD (LNG-IUD) represents an attractive long-term drug delivery system for the treatment of endometriosis during adolescence and young adulthood. However, while the LNG-IUD has an acceptable safety profile, it is not associated with a favorable bleeding profile and may not fully suppress endometriosis pain when used as monotherapy. Investigators hypothesize that the addition of NETA will improve bleeding patterns, maximize pain control, and improve continuation rates of the IUD when the two medications are used in combination. This proposed prospective trial provides the ideal context in which to investigate these clinical questions and advance research on the best treatments for endometriosis.

Timeline

Start
2026-01-01
Primary completion
2028-09-01
Completion
2029-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Norethindrone Unknown 5 mg Oral

Indications