Vaginal and Urinary Microbiome Trial

University of Louisville (UOFL)

Status and phase

Completed

Phase 4

Conditions

Atrophic Vaginitis

Menopause

Recurrent Urinary Tract Infections

Treatments

Drug: Conjugated equine estrogen topical cream

Drug: Apricot kernel oil

Study type

Interventional

Funder types

Other

Identifiers

NCT02869165

16.0428

Details and patient eligibility

About

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.

Full description

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. 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 conjugated equine estrogen topical cream (Premarin®) and a nonhormonal alternative (apricot kernel oil). The participants will be randomized to either conjugated equine estrogen topical 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.

Enrollment

110 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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