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Sponsored by: |
Columbia Laboratories |
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Information provided by: | Columbia Laboratories |
ClinicalTrials.gov Identifier: | NCT00651313 |
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).
Condition | Intervention | Phase |
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Dysmenorrhea |
Drug: Lidocaine Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Double-Blind, Crossover Study to Assess the Efficacy and Safety of 10% (150mg) Lidocaine Vaginal Gel Administered to Women With Recurrent Dysmenorrhea |
Estimated Enrollment: | 150 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Active Comparator
Lidocaine 10% (150mg) vaginal gel
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Drug: Lidocaine
Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
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Placebo: Placebo Comparator
Placebo vaginal gel
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Drug: Placebo
Placebo vaginal gel administered once daily for 4 days
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The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.
The secondary objectives of this study are the following:
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Lyndhurst Gynecologic Associates | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Tennessee | |
SCIREX Research Center | |
Memphis, Tennessee, United States, 38120 | |
United States, Texas | |
SCIREX Research Center | |
Austin, Texas, United States, 78705 | |
United States, Utah | |
Jean Brown Research | |
Salt Lake City, Utah, United States, 84124 |
Study Director: | George W Creasy, MD | Columbia Laboratories |
Responsible Party: | VP, Clinical Research Columbia Laboratories ( George W. Creasy, MD, FACOG ) |
Study ID Numbers: | COL-1077-04 |
Study First Received: | March 28, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00651313 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dysmenorrhea Periods Menstrual Primary dysmenorrhea in women with recurrent dysmenorrhea |
Lidocaine Anesthetics Central Nervous System Depressants Pain Cardiovascular Agents Recurrence Anesthetics, Local |
Signs and Symptoms Pelvic Pain Dysmenorrhea Menstruation Disturbances Peripheral Nervous System Agents Anti-Arrhythmia Agents |
Physiological Effects of Drugs Lidocaine Anesthetics Central Nervous System Depressants Pain Cardiovascular Agents Anesthetics, Local Pharmacologic Actions Signs and Symptoms |
Pathologic Processes Pelvic Pain Dysmenorrhea Menstruation Disturbances Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents |