WithdrawnPhase 2

IUD and Norethindrone Acetate for Treatment of Endometriosis

Stopped: No funding

United States0Started 2026-01-01

Plain-language 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.

Who can participate

Age range13 Years – 24 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Pain-Physical functioning assessed by the BPI

Timeframe: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Change in pain severity measured by Visual Analog Scale (VAS)

Timeframe: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Change in pain measured by Biberoglu and Behrman patient ratings scale (B&B pain scale)

Timeframe: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Change in Emotional functioning, assessed by the Beck Depression Inventory-II (BDI)

Timeframe: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Change in Participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale (PGIC)

Timeframe: Baseline, 3 Months, 6 Months, 9 Months, 12 Months

Trial details

NCT IDNCT04948489

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

View on ClinicalTrials.gov More Endometriosis trials