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NCT03970330 · ClinicalTrials.gov registry record · Phase 3
Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
A Phase 3 study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 9
- Enrollment target
NCT03970330: Clinical Trial Phase 3 study, sponsored by Milton S. Hershey Medical Center.
NCT03970330 is a Phase 3 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 9 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970330, a Phase 3 study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 9 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Pain is reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). The final outcome measure will be calculated as area under the curve from randomization through 12-weeks of intervention. AUC was calculated using the trapezoid rule. Calculated AUC per subject across this 12-week period can range from 0 - 8300.
Interventions
- DRUG Placebo
- DRUG Norethindrone Acetate
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-01-16 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 3 |
Why NCT03970330 stopped before completion
NCT03970330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03970330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03970330 about?
NCT03970330 is a clinical study titled "Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis". 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.
What is the current status of trial NCT03970330?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 9 participants. The study started on 2020-01-16. Estimated completion is 2021-06-21.
What interventions are being tested in trial NCT03970330?
The interventions under investigation include: Placebo (DRUG), Norethindrone Acetate (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT03970330?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03970330's enrollment target sits among peer trials
9 1992nd of 2000 higher than 8 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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