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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 17, 2010

Status Verified

December 1, 2010

Enrollment Period

6 months

First QC Date

March 9, 2010

Last Update Submit

December 16, 2010

Conditions

Study Arms (2)

Vaginal Dryness

Non-vaginal dryness

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Postmenopausal women

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Family Medical Center

London, Ontario, ON N5Z, Canada

Location

Study Officials

  • Gregor Reid, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 17, 2010

Record last verified: 2010-12

Locations