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

This study has been completed.

First Received: December 26, 2007 Last Updated: July 21, 2009 History of Changes

Sponsor:	KV Pharmaceutical Company
Information provided by:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00590590

Purpose

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.

Condition	Intervention	Phase
Vulvodynia	Drug: Lidocaine/Diphenhydramine Drug: lidocaine Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Resource links provided by NLM:

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine citrate Lidocaine Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by KV Pharmaceutical Company:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	140
Study Start Date:	October 2007
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
3: Placebo Comparator	Drug: placebo semi solid, twice weekly for 4 months
1: Experimental	Drug: Lidocaine/Diphenhydramine semi solid, twice weekly, 4 months
2: Experimental	Drug: lidocaine semi solid, twice weekly for 4 months

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590590

Show 48 Study Locations

Sponsors and Collaborators

KV Pharmaceutical Company

Investigators

Study Director:

Chang Lee, MD

KV Pharmaceutical Company

More Information

No publications provided

Responsible Party:	KV Pharmaceutical ( Chang Lee, MD Vice President Clinical and Medical Affairs )
Study ID Numbers:	LDC-201-601-669020
Study First Received:	December 26, 2007
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00590590 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiemetics
Anesthetics
Promethazine
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics
Anti-Arrhythmia Agents
Dermatologic Agents
Gastrointestinal Agents

Lidocaine
Histamine Agents
Central Nervous System Depressants
Cardiovascular Agents
Anti-Allergic Agents
Pharmacologic Actions
Anesthetics, Local
Histamine Antagonists
Autonomic Agents
Histamine H1 Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Diphenhydramine

ClinicalTrials.gov processed this record on February 08, 2010