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 Title
Vaginal and Urinary Microbiome Trial
Protocol ID
NCT02869165
Lead Sponsor
University of Louisville
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 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 Count
110 participants
Eligibility 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
Filters
Atrophic Vaginitis
Menopause
Recurrent Urinary Tract Infections
PHASE4
COMPLETED
ADULT
OLDER_ADULT