Vaginal and Urinary Microbiome Trial

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Louisville
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

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 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