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NCT05968937 · ClinicalTrials.gov registry record · Phase 2

Vaginal Baclofen Suppositories in Chronic Pelvic Pain

A Phase 2 study of Chronic Pelvic Pain Syndrome, sponsored by University of Louisville.

Recruiting
Registry status
Phase 2
Development phase
44
Enrollment target
1
Study location

NCT05968937 is a Phase 2 study of Chronic Pelvic Pain Syndrome that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 44 participants, below the 193-participant average among 11 other Chronic Pelvic Pain Syndrome trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05968937, a Phase 2 study of Chronic Pelvic Pain Syndrome, is actively recruiting participants, sponsored by University of Louisville.

RECRUITING
Registry status
Phase 2
Development phase
44 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain (CPP). Participants in this study will take four short questionnaires prior to being randomized. Randomization is like flipping a coin; participants have an equal likelihood of being randomized to the treatment group (vaginal baclofen suppositories) or placebo group (vaginal suppository without baclofen ingredient). Participants will take their assigned treatment nightly for 8 weeks. Follow up visits will be at the 4 and 8 week time frames, when questionnaires will again be completed. Participants may receive additional treatments for CPP during the course of the study. After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped. Follow up on patient symptoms with questionnaires will again occur at 12 weeks.

Interventions

  • DRUG Placebo
  • DRUG 20 mg baclofen vaginal suppository daily per vagina

Study Locations (1)

Kentucky

  • ULP Female Pelvic Medicine and Reconstructive Surgery - Springs Medical Center Suite 190 - Louisville

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2024-01-01
Est. Completion 2026-06-01
Phase Phase 2

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT05968937

The ClinicalTrials.gov registry entry for NCT05968937 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 11 other Chronic Pelvic Pain Syndrome trials with a reported enrollment target (77% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Pelvic Pain Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05968937 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT05968937 about?

NCT05968937 is a clinical study titled "Vaginal Baclofen Suppositories in Chronic Pelvic Pain". The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain (CPP). Participants in this study will take four short questionnaires prior to being randomized. Randomization is like flipping a coin; participants have an equal likelihood of being r...

What is the current status of trial NCT05968937?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2024-01-01. Estimated completion is 2026-06-01.

What conditions does trial NCT05968937 study?

This clinical trial studies the following conditions: Chronic Pelvic Pain Syndrome.

What interventions are being tested in trial NCT05968937?

The interventions under investigation include: Placebo (DRUG), 20 mg baclofen vaginal suppository daily per vagina (DRUG).

Who is sponsoring clinical trial NCT05968937?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05968937 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.