Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT03970330
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Naltrexone — DRUG
    4.5mg daily dose, taken orally
  • Norethindrone Acetate — DRUG
    5 - 15mg daily dose, taken orally
  • Placebo — DRUG
    daily placebo pill, taken orally

Study Details

The purpose of this study is to determine if the addition of Low Dose Naltrexone to standard endometriosis treatments will improve patient reported endometriosis associated pain.

Key Dates

Start date
Jan 16, 2020
Status verified
Oct 2022
Primary completion
Jun 21, 2021
Completion
Jun 21, 2021

Study Design

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

Arms

  • Experimental: Low-Dose Naltrexone
    12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5-15 mg daily norethindrone acetate
  • Placebo Comparator: Placebo
    12-week intervention period of daily placebo in combination with standard treatment of 5-15 mg daily norethindrone acetate

Primary Outcome Measure

Pain Score Area Under the Curve (AUC) [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Hershey Medical CenterHersheyPennsylvania17033-

Find similar trials in Hershey, PA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Penn State Hershey Medical Center· Hershey, PA

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