Trial · NCT03970330
Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
NCT03970330, Phase 3, Terminated, Milton S. Hershey Medical Center; results first posted 2022-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis. Trials, record NCT03970330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03970330
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
- NCT number
- NCT03970330
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 9 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Endometriosis
- Interventions
- Naltrexone, Norethindrone Acetate, Placebo
- First posted
- 2019-05-31
- Last updated
- 2022-11-03
- Results first posted
- 2022-11-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Score Area Under the Curve (AUC) | 12 weeks | 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. |
| Secondary | EHP-30 Score | Baseline, 4, 8, 12, and 16 weeks | Quality of life measured by the validated Endometriosis Health Profile (EHP-30) questionnaire. Scores range from 0 (best health status) to 100 (worst health status). |
| Secondary | PGIC Score (Painful Periods) | 4, 8, 12 and 16 weeks | Patient's Global Impression of Change (PGIC) scale will be used to rate painful periods. This is a 7 point scale ranging from 1 (much worse) to 7 (much better). |
| Secondary | PGIC Score (Nonmenstrual Pelvic Pain) | 4, 8, 12 and 16 weeks | Patient's Global Impression of Change (PGIC) scale will be used to rate nonmenstrual pelvic pain. This is a 7 point scale ranging from 1 (much worse) to 7 (much better). |
| Secondary | PGIC Score (Dyspareunia) | 4, 8, 12 and 16 weeks | Patient's Global Impression of Change (PGIC) scale will be used to rate pelvic pain during sex. This is a 7 point scale ranging from 1 (much worse) to 7 (much better). |
| Secondary | Ibuprofen Use | 12 weeks | Average # of ibuprofen 200 mg pills per week during the study treatment period |
| Secondary | Oxycodone Use | 12 weeks | Number of subjects who used oxycodone at any time during the study |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Score Area Under the Curve (AUC) | 12 weeks | units on a scale*days | MEAN | |
| SECONDARY | EHP-30 Score | Baseline, 4, 8, 12, and 16 weeks | score on a scale | MEAN | |
| SECONDARY | PGIC Score (Painful Periods) | 4, 8, 12 and 16 weeks | units on a scale | MEDIAN | |
| SECONDARY | PGIC Score (Nonmenstrual Pelvic Pain) | 4, 8, 12 and 16 weeks | units on a scale | MEDIAN | |
| SECONDARY | PGIC Score (Dyspareunia) | 4, 8, 12 and 16 weeks | This measure was only assessed in patients who had intercourse during study treatment. | units on a scale | MEDIAN |
| SECONDARY | Ibuprofen Use | 12 weeks | pills/week | MEAN | |
| SECONDARY | Oxycodone Use | 12 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Score Area Under the Curve (AUC) | Low-Dose Naltrexone | 2461 | Standard Deviation 1445 | units on a scale*days | |
| Pain Score Area Under the Curve (AUC) | Placebo | 1338 | Standard Deviation 697 | units on a scale*days | |
| EHP-30 Score | Low-Dose Naltrexone | Baseline | 56.5 | Standard Deviation 18.3 | score on a scale |
| EHP-30 Score | Placebo | Baseline | 27.6 | Standard Deviation 19.4 | score on a scale |
| EHP-30 Score | Low-Dose Naltrexone | Week 4 | 35.5 | Standard Deviation 16.6 | score on a scale |
| EHP-30 Score | Placebo | Week 4 | 25.1 | Standard Deviation 17.1 | score on a scale |
| EHP-30 Score | Low-Dose Naltrexone | Week 8 | 34.9 | Standard Deviation 22.8 | score on a scale |
| EHP-30 Score | Placebo | Week 8 | 16.0 | Standard Deviation 8.0 | score on a scale |
| EHP-30 Score | Low-Dose Naltrexone | Week 12 | 34.1 | Standard Deviation 26.6 | score on a scale |
| EHP-30 Score | Placebo | Week 12 | 18.6 | Standard Deviation 15.8 | score on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-Dose Naltrexone | 5 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | Low-Dose Naltrexone | 5 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Low-Dose Naltrexone | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastritis | Gastrointestinal disorders | Low-Dose Naltrexone | 1 | 5 | 1 |
| other | Gastritis | Gastrointestinal disorders | Placebo | 0 | 4 | 0 |
| other | Nausea | Gastrointestinal disorders | Low-Dose Naltrexone | 0 | 5 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 4 | 1 |
| other | Vomiting | Gastrointestinal disorders | Low-Dose Naltrexone | 0 | 5 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 4 | 1 |
| other | Acne | Skin and subcutaneous tissue disorders | Low-Dose Naltrexone | 0 | 5 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Placebo | 1 | 4 | 1 |
| other | Poison Ivy | Skin and subcutaneous tissue disorders | Low-Dose Naltrexone | 0 | 5 | 0 |
| other | Poison Ivy | Skin and subcutaneous tissue disorders | Placebo | 1 | 4 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-Dose Naltrexone | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | Low-Dose Naltrexone | 3 | 5 |
| Total, other adverse events | Placebo | 4 | 4 |
| Total, serious adverse events | Low-Dose Naltrexone | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low-Dose Naltrexone vs Placebo: Oxycodone Use | Trial comparisons |
| Low-Dose Naltrexone vs Placebo: deaths from any cause | Trial comparisons |
| Low-Dose Naltrexone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03970330
GET https://conductscience.org/api/trials/v1/NCT03970330/results?page=2