Trials / Withdrawn
WithdrawnNCT02869425
To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS
A Randomized, Double-Blind, Parallel-Group Study to Assess the Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With Multiple Sclerosis
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- RVL Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to assess the effects of a therapeutic dose of arbaclofen extended release (ER) tablets compared with placebo on human sperm concentration, motility, and morphology in male subjects with multiple sclerosis (MS).
Detailed description
Primary Objective: 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. Secondary Objectives: The secondary safety objectives are to assess: * The effects of AERT compared with placebo on the following sperm parameters from baseline to the end of 90 days of treatment in male subjects with MS: * Semen volume and total sperm count per ejaculate; * Sperm motility; * Sperm morphology; and * Plasma levels of reproductive hormones: Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and total testosterone; * The recovery of subjects with 50 % decrease in sperm parameters 90 days after the discontinuation of IP; and * The safety and tolerability of IP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | arbaclofen ER Tablets | arbaclofen ER tablets, 10 mg, 15 mg, or 20 mg |
| DRUG | Placebo for arbaclofen ER tablets | matching placebo tablets to arbaclofen ER tablets 10 mg, 15 mg or 20 mg |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-10-01
- Completion
- 2019-01-01
- First posted
- 2016-08-17
- Last updated
- 2022-04-27
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02869425. Inclusion in this directory is not an endorsement.