Phase 2
N=49
Vaginal Diazepam for the Treatment of Female Pelvic Pain
Pelvic Floor Disorders · Pelvic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01938092 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Visual Analog Scale (VAS) for Pain — 50; 39 score on a scale — p=0.62
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Diazepam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Raymond Foster
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) for Pain |
50; 39 | 0.62 |
| SECONDARY Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire Score at 4 Weeks. |
96; 107 | 0.66 |
| SECONDARY McGill Pain Questionnaire Score (PRI) at 4 Weeks |
34; 33 | 0.88 |
Summary
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.
Eligibility Criteria
Inclusion Criteria
- Age 18 years old
- Primary complaint of acute or chronic pelvic pain with or without dyspareunia
- Physical exam findings consistent with levator muscle spasm
- Capable of inserting tablet in vagina without use of applicator.
Exclusion Criteria
- Chronic narcotic use
- Non-English speaking
- Currently serving a prison sentence
- Stage III or greater vaginal prolapse
- Allergies or contraindications to benzodiazepines
- Pregnant or breastfeeding
- Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal valium therapy
- Unwilling or incapable of inserting tablet in vagina without applicator.
Data sourced from ClinicalTrials.gov (NCT01938092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.