Phase 2 Completed N=49 Randomized Triple-blind Treatment

Vaginal Diazepam for the Treatment of Female Pelvic Pain

Pelvic Floor Disorders · Pelvic Pain

Source: ClinicalTrials.gov NCT01938092 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcomePrimary: Visual Analog Scale (VAS) for Pain — 50; 39 score on a scale — p=0.62

Summary

To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain associated with pelvic floor hypertonic disorder.

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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.