Vaginal Microbiota Among Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01084616
First received: March 9, 2010
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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
Vulvovaginal Atrophy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Vaginal Microbiota in Symptoms of Vaginal Dryness in Postmenopausal Women

Further study details as provided by Lawson Health Research Institute:

Enrollment: 16
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vaginal Dryness
Non-vaginal dryness

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Postmenopausal women

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084616

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Dr. Gregor Reid, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01084616     History of Changes
Other Study ID Numbers: R-09-804, 16182E
Study First Received: March 9, 2010
Last Updated: December 16, 2010
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 22, 2014