Vaginal and Urinary Microbiome Trial

Completed · Phase 4

Conditions studied: Atrophic Vaginitis, Menopause, Recurrent Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT02869165

Run by

University of Louisville

People needed

110

Starts

2017-01-01

Expected to finish

2019-12-31

Last updated by the study team

2021-05-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 last outbreak <1month ago, or vaginal laceration.
• Chronic antibiotic or probiotic use for indications not listed.
• Pelvic organ prolapse beyond the hymenal ring
• Using a vaginal pessary or indwelling urinary catheter
• Evidence of active urinary tract infection by history and symptoms, urine dipstick, or urine culture on day of presentation or within last 2 weeks (defined as ≥ 100,000 colonies same pathologic bacteria on clean catch or 10,000 colonies on straight catheter specimen)
• Recurrent urinary tract infection 3 episodes with the last year or 2 episodes within the last 6 months.
• History of venous or arterial thromboembolism or genetic predisposition to thromboembolism.
• Ovarian cancer and estrogen responsive cancer including endometrial or breast or breast cancer history of unknown hormonal status
• Vaginal mesh erosion, sutures visible in the vagina or granulation tissue
• Uncorrected vesicovaginal or rectovaginal fistula
• Severe fecal or anal incontinence
• Active vulvar dermatoses (lichen sclerosis, Behcet's disease, vulvar eczema) and on chronic topical steroids.
• Subjects with absolute contraindications to estrogen, such as diabetes mellitus with end-organ damage and vascular disease, impaired liver function or a hepatic hemangioma, chronic renal disease, migraine with aura, systemic lupus erythematosus with prior thrombosis or vascular damage or other end-organ damage
• Patients < 6 weeks postop
• Inability to speak or read English

Where it is running

• Health Care Outpatient Center and Springs Medical Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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