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NCT01084616 Clinical Trial

Vaginal Microbiota Among Postmenopausal Women

Vulvovaginal Atrophy Clinical Trial

Official title:
The Role of Vaginal Microbiota in Symptoms of Vaginal Dryness in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01084616
Other study ID # R-09-804
Secondary ID 16182E
Status Completed
Phase N/A
First received March 9, 2010
Last updated December 16, 2010
Start date January 2010
Est. completion date July 2010

Study information
Verified date December 2010
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Victoria Family Medical Center London Ontario

Sponsors (1)
Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

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