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Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)

NCT00651313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2012-02-17

Study results available
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Summary

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).

Conditions

  • Dysmenorrhea

Interventions

DRUG

Lidocaine

Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days

DRUG

Placebo

Placebo vaginal gel administered once daily for 4 days

Sponsors & Collaborators

  • Juniper Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • George W Creasy, MD · Juniper Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-06-30
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651313 on ClinicalTrials.gov