Pregabalin for the Treatment of Vulvodynia

NCT00853229 | Terminated Phase 2 Results

• 1 other identifier: CCF 08-195
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether pregabalin is effective in the treatment of vulvodynia.

Conditions

Vulvodynia; Vulvar Vestibulitis

Keywords

vulvodynia; vulvar vestibulitis; chronic vulvar pain; generalized vulvodynia; localized vulvodynia

Outcome Measures

Primary Outcomes (1)

• Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)

  The primary objective of this protocol is to compare the reduction in pain using an 11-point scale (0-10) at four weeks of treatment. A responder will be defined as a subject noting a ≥50% reduction in pain using this scale. The NRS is an 11-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.

  4 weeks

Secondary Outcomes (1)

• Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)

  4 weeks

Study Arms (2)

pregabalin/placebo

EXPERIMENTAL

pregabalin and placebo given using a cross-over design

Drug: pregabalin

placebo/pregabalin

EXPERIMENTAL

placebo and pregabalin given using a cross-over design

Drug: pregabalin

Interventions

pregabalin DRUG

pregabalin 150mg twice daily for 4 weeks

Also known as: Lyrica

placebo/pregabalin; pregabalin/placebo

Eligibility Criteria

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

You may qualify if:

• Adult women age 18 or greater
• Vulvodynia as defined as chronic vulvar discomfort or pain, characterized by burning, stinging, irritation or rawness of the female genitalia in cases in which there is no infection or skin disease of the vulva or vagina causing these symptoms. Pain may be constant or intermittent, localized or diffuse. Symptoms may be consistent with either Generalized Vulvodynia (diffuse or focal and constant or unremitting symptoms present in the labia majora, labia minora, and/or the vestibule that are not necessarily caused by touch or pressure to the vulva) or Vulvar Vestibulitis Syndrome (pain only in the vestibule and only during or after touch or pressure is applied).
• Pain ≥ 40 on 100mm VAS
• Practicing reliable form of birth control defined as sterilization, hormonal contraception, abstinence, IUD
• Must be able to attend follow up visits and are not likely to leave the area during the study period

You may not qualify if:

• Atrophic vaginitis, active bacterial vaginosis, yeast, and herpetic infections
• Current pregnancy diagnosed by positive serum or urine pregnancy test
• Current breastfeeding
• Seizure disorder or other chronic neurologic disease
• Diagnosis of chronic renal insufficiency defined as creatinine \>1.4
• Unable to read and speak English
• Contraindication to pregabalin or history of prior use of pregablin
• Chronic narcotic or benzodiazepine use
• Chronic alcohol abuse
• Other chronic pain disorders, (ie. chronic pelvic pain, endometriosis, interstitial cystitis)
• Chronic neuropathic pain or anything affecting sensation (ie. MS, stroke)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Vulvodynia; Vulvar Vestibulitis

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Lynn Borzi (Research Administrator)
• Organization: Cleveland Clinic

BORZIL@ccf.org

216-445-3158

Study Officials

• Beri M Ridgeway, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Matthew D Barber, MD, MHS

  The Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 19, 2021
• Results First Posted: May 15, 2017

Record last verified: 2021-06

Locations

US (1)