Trial · NCT02869425
To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS
NCT02869425, Phase 3, Withdrawn, RVL Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS. Trials, record NCT02869425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02869425
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS
- NCT number
- NCT02869425
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- RVL Pharmaceuticals, Inc.
- Conditions
- Multiple Sclerosis, Sperm
- Interventions
- arbaclofen ER Tablets, Placebo for arbaclofen ER tablets
- First posted
- 2016-08-17
- Last updated
- 2022-04-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measure of sperm concentration according to WHO guidelines | 90 days of treatment | The primary safety objective is to assess the effects of arbaclofen ER tablets (AERT) compared with placebo on sperm concentration from baseline to the end of 90 days of treatment in male subjects with MS. Analyses are performed by World Health Organization (WHO) guidelines (WHO, 2010) to obtain volume (mL), pH, sperm concentration motility, and morphology |
| Secondary | Measure of sperm motility according to the WHO guidelines | 90 days of treatment | |
| Secondary | Measure of Plasma levels of FSH, LH, and total testosterone values and their respective change from baseline values will be summarized by visit | 90 days of treatment | Plasma levels of FSH, LH, and total testosterone values and their respective change from baseline values will be summarized by visit using an 8-number summary (n, mean, median, SD, 25th percentile, 75th percentile, minimum value, and maximum value). |
| Secondary | Measure of Semen volume per ejaculate according to the WHO guidelines | 90 days of treatment | |
| Secondary | Measure of total sperm count per ejaculate according to the WHO guidelines | 90 days of treatment | |
| Secondary | Measure of Sperm morphology according to the WHO guidelines | 90 days of treatment | |
| Secondary | The recovery of subjects with 50% decrease in sperm parameters 90 days after the discontinuation of IP | 90 days of treatment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02869425
GET https://conductscience.org/api/trials/v1/NCT02869425/registered