Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

July 21, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome measure of the study will be measurement of a woman's ability to have vaginal intercourse. [ Time Frame: baseline and for 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00590590 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Important secondary outcome measures include change in discomfort. [ Time Frame: baseline and for 4 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

Official Title ^ICMJE

Brief Summary

This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Vulvodynia

Intervention ^ICMJE

Drug: Lidocaine/Diphenhydramine
semi solid, twice weekly, 4 months
Drug: lidocaine
semi solid, twice weekly for 4 months
Drug: placebo
semi solid, twice weekly for 4 months

Study Arms / Comparison Groups

3: Placebo Comparator
Intervention: Drug: placebo
1: Experimental
Intervention: Drug: Lidocaine/Diphenhydramine
2: Experimental
Intervention: Drug: lidocaine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

140

Completion Date

July 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must have sought doctor's care for this condition.
Patients must be having menstrual cycles.

Exclusion Criteria:

Patients must not have any vaginal infections.
Patients must not be pregnant or nursing.
Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00590590

Responsible Party

Chang Lee, MD Vice President Clinical and Medical Affairs, KV Pharmaceutical

Study ID Numbers ^ICMJE

LDC-201-601-669020

Study Sponsor ^ICMJE

KV Pharmaceutical Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Chang Lee, MD

KV Pharmaceutical Company

Information Provided By

KV Pharmaceutical Company

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP