NCT00651313

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Juniper Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Lidocaine	Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
DRUG	Placebo	Placebo vaginal gel administered once daily for 4 days

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2008-04-02
• Last updated: 2012-02-17
• Results posted: 2011-07-06

Locations

4 sites across 1 country: United States