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Vaginal Microbiota Among Postmenopausal Women

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01084616
Collaborator
(none)
16
Enrollment
1
Location
5.9
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is known that vaginal bacteria have an impact upon the health status of the host, in some cases protecting against infection and in other cases causing infection, depending on the bacterial types present. This study will compare the composition of vaginal bacteria to symptoms of vaginal dryness in order to try and identify if certain bacteria might cause some of the problems associated with vaginal dryness among post-menopausal women.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    16 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Role of Vaginal Microbiota in Symptoms of Vaginal Dryness in Postmenopausal Women
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Jul 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Vaginal Dryness
    Non-vaginal dryness

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      30 Years to 80 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Between 30 and 80 years old.

      • Postmenopausal = 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.

      • Prepared not to take hormone replacement therapy during 8 weeks follow-up and not taking estrogen alone or estrogen/progestin containing drug products at the time of screening.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Victoria Family Medical Center London Ontario Canada ON N5Z

      Sponsors and Collaborators

      • Lawson Health Research Institute

      Investigators

      • Principal Investigator: Gregor Reid, PhD, Lawson Health Research Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01084616
      Other Study ID Numbers:
      • R-09-804
      • 16182E
      First Posted:
      Mar 10, 2010
      Last Update Posted:
      Dec 17, 2010
      Last Verified:
      Dec 1, 2010
      Additional relevant MeSH terms:
      Atrophy

      Study Results

      No Results Posted as of Dec 17, 2010