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Hormone Therapy
IUD + Norethindrone Acetate for Endometriosis
Phase 2
Waitlist Available
Led By Amy DiVasta
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 13 to 24 years
Female with surgically confirmed endometriosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months, 12 months
Awards & highlights
Study Summary
This trial is investigating whether adding NETA to the levonorgestrel-containing IUD will improve pain control and continuation rates for adolescents and young adults with endometriosis.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include changes in menstrual bleeding patterns, abdominal discomfort or cramps related to the IUD insertion process. NETA may cause weight gain, headache, mood swings, acne and breast tenderness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 24 years old.
Select...
I am a woman with endometriosis confirmed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Emotional functioning, assessed by the Beck Depression Inventory-II (BDI)
Change in Pain-Physical functioning assessed by the BPI
Change in Participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale (PGIC)
+2 moreSecondary outcome measures
Change in Bone mineral density Z-scores by dual energy Xray absorptiometry (DXA)
Change in Factor VIII activity
Change in Measure of arterial stiffness by pulse wave velocity
+9 moreTrial Design
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.
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
767 Previous Clinical Trials
5,580,429 Total Patients Enrolled
6 Trials studying Endometriosis
3,059 Patients Enrolled for Endometriosis
Amy DiVastaPrincipal InvestigatorBoston Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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 not taking drugs like erythromycin or ketoconazole.I do not have conditions that prevent me from using an IUD.I have a chronic illness or mental condition that affects how I feel pain.I am between 13 and 24 years old.I am a woman with endometriosis confirmed by surgery.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.
Research Study Groups:
This trial has the following groups:- Group 1: LNG IUD+Placebo
- Group 2: LNG IUD+ Norethindrone Acetate
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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