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 range

13 Years – 24 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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