Vaginal Microbiota Among Postmenopausal Women

NCT ID: NCT01084616

Last Updated: 2010-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vulvovaginal Atrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaginal Dryness

No interventions assigned to this group

Non-vaginal dryness

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Gregor Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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Victoria Family Medical Center

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16182E

Identifier Type: OTHER

Identifier Source: secondary_id

R-09-804

Identifier Type: -

Identifier Source: org_study_id