IUD + Norethindrone Acetate for Endometriosis

Overseen By Jenny Gallagher

Age: < 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Boston Children's Hospital

Must be taking: LNG-IUD

Must not be taking: CYP34a inducers/inhibitors

Disqualifiers: Liver disease, Lupus, Uncontrolled diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

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.

Research Team

Amy DiVasta, MD, MMSc

Principal Investigator

Boston Children's Hospital

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 have had pelvic pain rated 3 or higher for at least 2 months.

I am starting to use the LNG-IUD for birth control.

I am between 13 and 24 years old.

Exclusion Criteria

I have systemic lupus erythematosus.

I have liver disease or impaired liver function.

You are allergic to any part of the NETA or LNG-IUS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either LNG IUD with placebo or LNG IUD with norethindrone acetate for 12 months

12 months

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Norethindrone Acetate
• Placebo

Trial Overview 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.

Participant Groups

Group I: LNG IUD+ Norethindrone Acetate Experimental Treatment 1 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+Placebo Placebo Group 1 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:

• Endometriosis
• Abnormal Uterine Bleeding
• Amenorrhea
• Birth Control

Approved in Canada as Norlutate for:

• Endometriosis
• Abnormal Uterine Bleeding
• Amenorrhea
• Birth Control

Approved in European Union as Primolut-Nor for:

• Endometriosis
• Abnormal Uterine Bleeding
• Amenorrhea
• Birth Control
• Menopausal hormone therapy

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+