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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months for reporting.

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 more

Secondary 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 more

Trial 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

760 Previous Clinical Trials

5,579,600 Total Patients Enrolled

6 Trials studying Endometriosis

3,059 Patients Enrolled for Endometriosis

Amy DiVastaPrincipal InvestigatorBoston Children's Hospital

Media Library

Norethindrone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04948489 — Phase 2

Endometriosis Research Study Groups: LNG IUD+Placebo, LNG IUD+ Norethindrone Acetate

Endometriosis Clinical Trial 2023: Norethindrone Acetate Highlights & Side Effects. Trial Name: NCT04948489 — Phase 2

Norethindrone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04948489 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial allow participants aged 18 and older?

"This research is recruiting patients aged 13-24 years old."

Answered by AI

Has the Food and Drug Administration given its seal of approval to norethindrone acetate (NETA)?

"Given the lack of data supporting its efficacy, norethindrone acetate (NETA) was assigned a safety score of 2. Despite this rating, Phase 2 trial results do still demonstrate that it is relatively safe for use in research."

Answered by AI

Is the enrolment period still ongoing for this experiment?

"According to the information stored on clinicaltrials.gov, this study is not currently recruiting patients—the trial was initially posted in January of 2023 and last updated on September 14th 2022. However, there are 96 other trials actively looking for participants at present."

Answered by AI

Are there any existing studies that have looked into the use of norethindrone acetate (NETA)?

"Currently, 10 medical trials are in process researching norethindrone acetate (NETA), 6 of which have progressed to Phase 3. Despite the majority of NETA research being done at Toledo, Ohio sites, there are an expansive 622 individual locations conducting studies on this treatment."

Answered by AI

What medical ailments does norethindrone acetate (NETA) typically address?

"The vasomotor system is typically managed with the aid of norethindrone acetate (NETA). This medication has further applications for treating menopause, ovarian failure, and atrophic conditions."

Answered by AI

What goals are hoped to be achieved with this research endeavor?

"This trial's primary endpoint is the alteration of emotional functions, which will be evaluated by means of a Beck Depression Inventory-II (BDI). Secondary endpoints include changes to Tissue factor pathway inhibitor (TFPI), soluble P-selectin and interleukin-6 (IL-6) at Baseline, 3 Months, 6 Months, 9 Months and 12 Month time points. The goal here is to ascertain whether norethindrone acetate affects prothrombotic markers."

Answered by AI

How many volunteers are participating in the experiment?

"This clinical trial is not currently accepting applicants. Initially posted on the first of January 2023 and updated as recently as September 14th 2022, it appears to be dormant at this time. However, those looking for other medical trials involving endometrioma may find solace in the fact that there are 86 studies actively recruiting participants, while 10 different experiments related to norethindrone acetate (NETA) are also seeking patients."

Answered by AI

Are there any criteria for enrolment in this medical trial?

"This clinical trial seeks 80 adolescents and young adults between the ages of 13-24 who have endometrioma and are currently suffering from pelvic pain (score ≥ 3 on Visual Analog Scale) for at least two months prior to enrollment. Additionally, all applicants must be willing to comply with study protocol as well as visit schedule."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

IUD and Norethindrone Acetate for Treatment of Endometriosis

Amy DiVasta, MD 2024. "IUD and Norethindrone Acetate for Treatment of Endometriosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948489.

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