Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

NCT01233791 | Completed DMC

• 1 other identifier: 10025-10-021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.

Conditions

Female Patients With High Tone Pelvic Floor Dysfunction

Keywords

high tone pelvic floor dysfunction; levator pain; dyspareunia

Outcome Measures

Primary Outcomes (1)

• Surface EMG

  A baseline sEMG will be compared to sEMG after 28 days of treatment.

  After 28 days of treatment

Secondary Outcomes (6)

• Surface EMG Midpoint

  14 days after treatment

• FSFI

  28 days

• VAS

  28 days

• SF-12

  28 days

• PGI-I

  28 days

Study Arms (2)

Vaginal Diazepam Suppository

EXPERIMENTAL

Patients in this arm will be asked to use one vaginal suppository every night for 28 days

Drug: Vaginal Diazepam Suppository

Vaginal Placebo Suppository

PLACEBO COMPARATOR

Patients will be asked to use one vaginal suppository every night for 28 days

Drug: Placebo Suppository

Interventions

Vaginal Diazepam Suppository DRUG

10mg compounded vaginal suppository

Vaginal Diazepam Suppository

Placebo Suppository DRUG

Patients will be asked to use one vaginal suppository every night for 28 days

Vaginal Placebo Suppository

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
• aged 18-65
• high tone pelvic floor dysfunction

You may not qualify if:

• allergy to diazepam or any drug in the class of benzodiazepines
• current pelvic floor physical therapy
• pelvic surgery within the last 3 months
• current pregnancy, planning on pregnancy during the study period, or not sure if pregnant
• regular benzodiazepine, muscle relaxant, or daily alcohol use
• history of alcohol or drug abuse
• contraindications to diazepam: hepatic or renal dysfunction, myasthenia gravis, acute narrow angle glaucoma, severe respiratory insufficiency, sleep apnea

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Catrina C Crisp, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

US (1)