Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods) — Lidocaine 04  

Dysmenorrhea Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial Description

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:

• to assess the safety of 10% (150 mg) lidocaine gel compared with placebo

• to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dysmenorrhea

• NCT number: NCT00651313
• Study type: Interventional
• Source: Juniper Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 2007
• Completion date: August 2008