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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Juniper Pharmaceuticals, Inc.

Current Primary Outcome:

  • The Primary Efficacy Variable Will be the Time-weighted Average Pain Intensity Over 4 Treatment Days Using the 4 Point Categorical Scale. [ Time Frame: Two 4-day dosing regimens for two consecutive monthy menstrual cycles ]
  • Treatment-emgergent Adverse Events [ Time Frame: approximately two months, based on onset of menses ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate Electrocardiograms (ECGs) for Potentially Significant QT Changes at Approximate Peak Lidocaine Plasma Concentration After 4 Days of Dosing [ Time Frame: 7 hours following fourth dose in 2 consecutive menstrual cycles ]

Original Secondary Outcome: Same as current

Information By: Juniper Pharmaceuticals, Inc.

Dates:
Date Received: March 28, 2008
Date Started: August 2007
Date Completion:
Last Updated: February 16, 2012
Last Verified: February 2012