Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Chronic Pelvic Pain Syndrome, sponsored by University of Louisville.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
VAS is a 1-100mm scale with lower scores indicating less pain
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 2 |
What NCT05968937 shows while recruiting
NCT05968937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 193-participant average among 11 other Chronic Pelvic Pain Syndrome trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Pelvic Pain Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05968937's enrollment target sits among peer trials
44 8th of 11 higher than 4 of 11 other Chronic Pelvic Pain Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pelvic Pain Syndrome 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
-
Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
RECRUITING · NA
-
Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions
RECRUITING
-
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
RECRUITING · NA
-
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
RECRUITING
-
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
RECRUITING · NA
-
National Program to Overcome Pelvic Pain studY (POPPY)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI