IUD and Norethindrone Acetate for Treatment of Endometriosis

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital
• Treatments: Norethindrone; Norethindrone Acetate

Criteria

Inclusion Criteria:

• Female with surgically confirmed endometriosis

• Clinical decision to begin use of the LNG-IUD

• Age 13 to 24 years

• Current pelvic pain (score ≥ 3 on Visual Analog Scale) that has been present for at least 2 months prior to enrollment

• Willingness to comply with visit schedule and study protocol

Exclusion Criteria:

• Pre-menarche or post-menopause

• Previous gonadotropin-releasing agonist use

• Contraindications to an IUD (e.g., cavity-distorting uterine anomaly, acute pelvic inflammatory disease, <3 months from postpartum endometritis or septic abortion, local neoplasm, uterine bleeding of unknown etiology, breast cancer, untreated cervicitis or vaginitis or other lower genital tract infections)

• Active or historical venous thromboembolism, active or recent arterial thromboembolic disease

• Impaired liver function or liver disease

• Systemic lupus erythematosus

• Uncontrolled diabetes or uncontrolled hypertension (BPs >140s/90s)

• Hypersensitivity to any component of the NETA or LNG-IUS

• Concurrent use of moderate or strong CYP34a inducers or inhibitors (such as erythromycin, ketoconazole, phenobarbital, rifampin)

• Significant mental or chronic systemic illnesses that may impact pain assessment

• Breast feeding, giving birth within the last 6 months, pregnancy, or planning to become pregnant in the next 12 month