5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

NCT00450242 | Terminated Phase 2 Results

• 1 other identifier: 05-2332
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

• Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo.
• This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.

Conditions

Vulvar Vestibulitis

Keywords

vulvar vestibulitis; vestibulitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Report the Ability to Have Intercourse

  Participants' response upon inquiry.

  baseline, week 8

• Change in Visual Analog Scale (VAS) Scores With Intercourse From Baseline to Week 8

  Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain during intercourse during baseline and week 8 of the study, for lidocaine treated subjects and controls. The "mean" listed for each group is average week 8 score subtracted from the average baseline score.

  baseline, week 8

Secondary Outcomes (2)

• SF-12 Quality of Life Scores

  baseline, week 8

• Modified Gracely Pain Scale

  baseline, week 8

Study Arms (2)

5% Lidocaine cream

EXPERIMENTAL

5% topical lidocaine cream.

Drug: 5% topical lidocaine ointment

Placebo cream

PLACEBO COMPARATOR

Drug: Placebo cream

Interventions

5% topical lidocaine ointment DRUG

Lidocaine 5% in hydrophilic petrolatum, dime-sized amount, applied nightly.

5% Lidocaine cream

Placebo cream DRUG

hydrophilic petrolatum, dime-sized amount, applied nightly.

Placebo cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with the clinical diagnosis of vvs who have dyspareunia as their primary complaint. They must have a current sexual partner.

You may not qualify if:

• postmenopausal
• pure vaginismus
• generalized vulvodynia
• pudendal neuralgia
• pregnant, breastfeeding
• less than 2 months post delivery
• diagnosis of dermatologic condition on biopsy
• positive fungal culture
• currently on treatment for vvs
• history of lidocaine treatment for vvs

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Vulvar Vestibulitis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study terminated due to lack of funding and difficulties with recruitment. More extensive data analysis to include secondary outcome measures was not performed due to inability to fund statistical programming and analysis efforts.

Results Point of Contact

• Title: Denniz Zolnoun, MD, MPH
• Organization: University of North Carolina, Dept. of Obstetrics and Gynecology

denniz_zolnoun@med.unc.edu

919-966-7764

Study Officials

• Jacqueline Rohl, MD

  UNC Division of Advanced Laparoscopy and Pelvic Pain

  STUDY DIRECTOR

• Denniz Zolnoun, MD MPH

  UNC- Division of Advanced Laparoscopy and Pelvic Pain

  PRINCIPAL INVESTIGATOR

• John Steege, MD

  UNC Division of Advanced Laparoscopy and Pelvic Pain

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Study Start: December 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: July 16, 2012
• Results First Posted: July 16, 2012

Record last verified: 2012-06

Locations

US (1)