Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort

Completed · Phase 2 · Has a placebo group

Conditions studied: Vulvodynia

In brief

This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.

Key facts

Study ID

NCT00590590

Run by

Lumara Health, Inc.

People needed

105

Starts

2007-10-01

Expected to finish

2009-07-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have sought doctor's care for this condition.
• Patients must be having menstrual cycles.

You may not qualify if…

• Patients must not have any vaginal infections.
• Patients must not be pregnant or nursing.
• Must not be receiving any other medicinal therapies or any medications that would interfere with the outcome of the study.

Where it is running

• Montgomery Women's Health Associates, P.C. — Montgomery, Alabama, United States
• Star W. Research — Chandler, Arizona, United States
• Precision Trials LLC — Phoenix, Arizona, United States
• Searcy Medical Center — Searcy, Arkansas, United States
• Universal Biopharma Research Institute, Inc. — Dinuba, California, United States
• San Diego Clinical Research Center — San Diego, California, United States
• Red Rocks OB/GYN — Lakewood, Colorado, United States
• Taylor Associates/Gynecology — Farmington, Connecticut, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Clinical Research of Tampa Bay — Hudson, Florida, United States
• Innovative Research of W. Florida — Largo, Florida, United States
• Women's Health Care Specialists, PC — Paw Paw, Florida, United States
• Tampa Bay Women's Healthcare Alliance, LLP — Tampa, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Atlanta Women's Research Institute, Inc. — Atlanta, Georgia, United States
• Atlanta North Gynecology, PC — Roswell, Georgia, United States
• Womans Clinic — Boise, Idaho, United States
• Rosemark Women Care Specialists — Idaho Falls, Idaho, United States
• Women's Health Practice, LLC — Champaign, Illinois, United States
• Northern Indiana Womens Health Research — South Bend, Indiana, United States
• Female Pelvic Medicine and Urogynecology — Grand Rapids, Michigan, United States
• Boro Park ObGyn — Brooklyn, New York, United States
• Eastern Carolina Womens Center — New Bern, North Carolina, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Winston-Salem Woman Care, PA — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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