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Completed

NCT Number: NCT00590590

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

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.

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gain Medical Centre, Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Lidocaine/Diphenhydramine

Drug

semi solid, twice weekly, 4 months

Lidocaine

Drug

semi solid, twice weekly for 4 months

Placebo

Drug

semi solid, twice weekly for 4 months

Primary outcomes

  1. Mean Marinoff Dyspareunia Scale Score (MDSS) at End of Treatment (12 Weeks)

    Time frame: 12 weeks

    The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse

Secondary outcomes

  1. Change From Baseline in Marinoff Dyspareunia Scale Score at End of Treatment (12 Weeks)

    Time frame: Baseline -12 Weeks

    0-3 scale with 0=no dyspareunia and 3= completely prevents intercourse

  2. Change From Baseline in Overall Vulvar Vestibulitis Syndrome (VVS)-Related Discomfort Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Discomfort and 100 = Most Severe Discomfort]

    Time frame: 12 Weeks

  3. Change From Baseline in Overall Intercourse-Related Pain Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Pain and 100 = Most Severe Pain]

    Time frame: 12 weeks

  4. Change From Baseline in Overall Vulvar Vestibulitis Symptoms Visual Analog Scale (VAS) Score at End of Treatment (12 Weeks) [0 = No Symptoms and 100 = As Bad as They Can be]

    Time frame: 12 Weeks

  5. Change From Baseline in Tenderness (on a 0- to 3-point Scale) on Palpation at End of Treatment (12 Weeks) [Scale Rates the Severity of Pain; 0 =Absent and 3 = Severe]

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Lumara Health, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 10, 2008
Registry last updated
Mar 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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