IUD and Norethindrone Acetate for Treatment of Endometriosis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT04948489
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
13 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • norethindrone acetate (NETA) — DRUG
    5mg of the NETA capsule by mouth daily for 12 months
  • Placebo — DRUG
    Placebo capsule everyday for 12 months

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Mar 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LNG IUD+ Norethindrone Acetate
    All eligible participants will have the LNG-IUD. Experimental participants will also receive norethindrone acetate 5 mg by mouth daily for 12 months.
  • Placebo Comparator: LNG IUD+Placebo
    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.

Primary Outcome Measure

Change in Pain-Physical functioning assessed by the BPI [ Time Frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Boston Children's Hospital· Boston, MA

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