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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 48 Study Locations| Study Director: | Chang Lee, MD | KV Pharmaceutical Company |
More Information
| 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 |
|
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 |