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

Sponsor:	KV Pharmaceutical Company
Information provided by (Responsible Party):	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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Sexual Problems in Women

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

U.S. FDA Resources

Further study details as provided by KV Pharmaceutical Company:

Primary Outcome Measures:

Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse

Secondary Outcome Measures:

Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks) [ Time Frame: Baseline -12 Weeks ] [ Designated as safety issue: No ]
0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse
Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort] [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be] [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe] [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	105
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
Placebo Comparator: 3 (Placebo)	Drug: placebo semi solid, twice weekly for 4 months
Experimental: 1 (Lidocaine)	Drug: lidocaine semi solid, twice weekly for 4 months
Experimental: 2 (Lidocaine/Diphenhydramine)	Drug: Lidocaine/Diphenhydramine semi solid, twice weekly, 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:

Jim Joffrion

KV Pharmaceutical Company

More Information

No publications provided

Responsible Party:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00590590 History of Changes
Other Study ID Numbers:	LDC-201-601-669020
Study First Received:	December 26, 2007
Results First Received:	June 30, 2010
Last Updated:	February 29, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Diphenhydramine
Promethazine
Lidocaine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists

Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 24, 2012