IUD and Norethindrone Acetate for Treatment of Endometriosis
Key facts
- Who runs it
- Boston Children's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 1 Jan 2026
- Expected to end
- 1 Sept 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- norethindrone acetate (NETA)
- Placebo
- Record updated
- 21 March 2025
- Why it stopped
- No funding
Who can take part
- Age
- 13 years to 24 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous gonadotropin-releasing agonist use
- Concurrent use of moderate or strong CYP34a inducers or inhibitors (such as erythromycin, ketoconazole, phenobarbital, rifampin)
- 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
- Uncontrolled diabetes or uncontrolled hypertension (BPs >140s/90s)
- Hypersensitivity to any component of the NETA or LNG-IUS
- Significant mental or chronic systemic illnesses that may impact pain assessment
- Pre-menarche or post-menopause
- Systemic lupus erythematosus
- Breast feeding, giving birth within the last 6 months, pregnancy, or planning to become pregnant in the next 12 month
Where in United States
- Boston Children's HospitalBoston, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- LNG IUD+ Norethindrone AcetateTreatment being tested
All eligible participants will have the LNG-IUD. Experimental participants will also receive norethindrone acetate 5 mg by mouth daily for 12 months.
Treatment: norethindrone acetate (NETA)
- LNG IUD+PlaceboPlacebo, for comparison
All eligible participants will have the LNG-IUD. Participants in the placebo comparator group will also receive a placebo tablet, 1 tablet by mouth daily for 12 months.
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of the Levonorgestrel Intrauterine Device With Norethindrone Acetate for Treatment of Endometriosis in Adolescents and Young Adults
- Record updated
- 21 March 2025