Vaginal and Urinary Microbiome Trial (NCT02869165) | Clinical Trial Compass
CompletedPhase 4
Vaginal and Urinary Microbiome Trial
United States110 participantsStarted 2017-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-years old
* Women who qualify for vaginal estrogen
* Suitability for follow-up
* Hormonally post-menopausal status: Bilateral past ovarian removal, ≥1 year since last menses if uterus in place, OR hysterectomized woman with ≥1 ovary in place AND \>1 year of menopausal symptoms or laboratory confirmation of menopausal hormonal status (such as serum follicle stimulation hormone \>25 IU/mL)
* GSM symptoms (including, but not limited to genital symptoms of dryness, burning, itching, and irritation; sexual symptoms of lack of lubrication, discomfort or pain, and impaired sexual function; and urinary symptoms of urgency, frequency, dysuria and recurrent (UTIs)
Exclusion Criteria:
* Age \< 18-years old
* Known allergic reaction or other adverse reactions to Premarin® or any of its components or apricot kernel oil
* Nut allergy
* Inability to use or place vaginal therapy due to altered mental status or anatomical reasons
* Already using vaginal estrogen or apricot kernel oil in the past two weeks
* Known active vaginal infection (symptomatic and/or untreated) or completion of treatment for bacterial vaginosis or cervical/vaginal infection within one week of recruitment
* History of recurrent or chronic bacterial vaginosis with \> 2 episodes per year or symptoms reported for \> 6 months out of the last year.
* History of active vaginal ulcerative disease (active ulcers from atrophy, herpes symptoms at recruitment or herpes with \>2 outbreaks per year or…
What they're measuring
1
Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.