Clinical trialNCT00450242TerminatedPhase 2Interventional

5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis

SponsorUniversity of North Carolina, Chapel HillEnrollment14Vulvar Vestibulitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

* 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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Denniz Zolnoun, MD MPH
UNC- Division of Advanced Laparoscopy and Pelvic Pain
Principal Investigator
clinicaltrials.gov ↗
Jacqueline Rohl, MD
UNC Division of Advanced Laparoscopy and Pelvic Pain
Study Director
clinicaltrials.gov ↗
John Steege, MD
UNC Division of Advanced Laparoscopy and Pelvic Pain
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of North Carolina
Chapel Hill, North Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

5% topical lidocaine ointmentPlacebo cream

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Dec 2006
Primary completion: 31 Jan 2009
Completion: 31 Jan 2009
Last update posted: 16 Jul 2012
Registered enrollment: 14
Registry id: NCT00450242

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.