Clinical Trial: Vaginal and Urinary Microbiome Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effects of Vaginal Estrogen and a Nonhormonal Alternative on the Vaginal and Urinary Microbiome in Women With Genitourinary Syndrome of Menopause: A Randomized Controlled Trial

Brief Summary: A randomized controlled trial looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause.

Detailed Summary: This is a study is looking at the effects of vaginal estrogen and a nonhormonal alternative on the vaginal and urinary microbiome in women with genitourinary syndrome of menopause with the primary objective is to describe the bacterial communities associated in the vagina and urine of postmenopausal women receiving treatment for genitourinary syndrome of menopause with Premarin® vaginal cream and a nonhormonal alternative, such as, apricot kernel oil. The participants will be randomized to either Premarin vaginal cream or apricot kernel oil. They will be given validated questionnaires to assess their urinary and vaginal symptoms, sexual function, quality of life, and impressions of severity and improvement.
Sponsor: University of Louisville

Current Primary Outcome: Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens. [ Time Frame: 3 months ]

Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population, to be compared between the control (Premarin® vaginal estrogen) group and apricot kernel oil group. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (>50%) between the estrogen group and the non-estrogen alternative group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in vaginal symptom questionnaire (VSQ) [ Time Frame: 3 months ]
    Change in vaginal symptoms as assessed by vulvovaginal symptom questionnaire (VSQ) at baseline and after treatment.
  • Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens. [ Time Frame: 3 months ]
    Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population, to be compared between the control (Premarin® vaginal estrogen) group and apricot kernel oil group. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (>50%) between the baseline patients and the patients at 3 months and compare the change in prevalence in this taxonomic predominance between the two study groups.


Original Secondary Outcome: Same as current

Information By: University of Louisville

Dates:
Date Received: July 31, 2016
Date Started: January 2017
Date Completion: May 2018
Last Updated: April 26, 2017
Last Verified: April 2017