IUD + Norethindrone Acetate for Endometriosis

Palo Alto (17 mi)

Overseen byAmy DiVasta, MD, MMSc

Age: < 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boston Children's Hospital

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a combination of a hormone-releasing device placed in the uterus and a hormone pill to help young women with endometriosis manage pain and bleeding more effectively. The device releases a hormone to reduce pain, while the pill helps control bleeding and enhances the treatment's overall effectiveness.

Eligibility Criteria

This trial is for young females aged 13-24 with surgically confirmed endometriosis, experiencing pelvic pain. They must be planning to use an LNG-IUD and willing to follow the study's schedule and rules. It excludes those who are pre-menarche or post-menopause, have certain health conditions like liver disease or blood clots, take specific drugs affecting liver enzymes, have mental illnesses impacting pain assessment, are breastfeeding/recently gave birth/plan pregnancy soon, used certain hormone treatments before, or can't safely use an IUD.

Inclusion Criteria

I am between 13 and 24 years old.

I am a woman with endometriosis confirmed by surgery.

Exclusion Criteria

I have systemic lupus erythematosus.

I have liver disease or impaired liver function.

I am not taking drugs like erythromycin or ketoconazole.

I have used hormone therapy for reproductive health before.

I have had blood clots in my veins or arteries.

I have not started menstruating or I am post-menopausal.

My diabetes or high blood pressure is not under control.

Treatment Details

The study tests if adding Norethindrone Acetate (NETA) to a Levonorgestrel-containing IUD (LNG-IUD) improves bleeding patterns and controls pain better in adolescents and young adults with endometriosis. Participants will either receive NETA alongside their LNG-IUD treatment or a placebo without knowing which one they're getting.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LNG IUD+ Norethindrone AcetateExperimental Treatment1 Intervention

All eligible participants will have the LNG-IUD. Experimental participants will also receive norethindrone acetate 5 mg by mouth daily for 12 months.

Group II: LNG IUD+PlaceboPlacebo Group1 Intervention

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.

Norethindrone Acetate is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Aygestin for: