Vaginal and Urinary Microbiome Trial

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT02869165

Collaborator

(none)

110

Enrollment

Location

Arms

35.9

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Vaginitis Menopause Recurrent Urinary Tract Infections	Drug: Conjugated equine estrogen topical cream Drug: Apricot kernel oil	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conjugated equine estrogen topical cream The conjugated equine estrogen topical vaginal cream 0.5 grams per vagina two times per week at nights for 3 months.	Drug: Conjugated equine estrogen topical cream Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use. Other Names: Premarin vaginal cream Vaginal estrogen cream CEE topical cream
Experimental: Apricot kernel oil One teaspoonful per vagina every night for 3 months.	Drug: Apricot kernel oil Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use. Other Names: Natural oil Organic oil

Arm

Intervention/Treatment

Experimental: Conjugated equine estrogen topical cream

The conjugated equine estrogen topical vaginal cream 0.5 grams per vagina two times per week at nights for 3 months.

Drug: Conjugated equine estrogen topical cream

Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use.

Other Names:

Premarin vaginal cream

Vaginal estrogen cream

CEE topical cream

Experimental: Apricot kernel oil

One teaspoonful per vagina every night for 3 months.

Drug: Apricot kernel oil

Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use.

Other Names:

Natural oil

Organic oil

Outcome Measures

Primary Outcome Measures

Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens. [3 months]
Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population compared between conjugated equine estrogen cream (Premarin) and apricot kernel oil. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (>50%) between the estrogen group and the non-estrogen alternative group.

Secondary Outcome Measures

Change in vaginal symptom questionnaire (VSQ) [3 months]
Change in vaginal symptoms as assessed by vulvovaginal symptom questionnaire (VSQ) at baseline and after treatment.
Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens. [3 months]
Predominance (greater than 50%) in vaginal and urinary specimen of anaerobic and/or fastidious organisms in the study population compared between the conjugated equine estrogen cream (Premarin) and apricot kernel oil. The primary analysis will compare the prevalence of genomic taxonomic anaerobic and/or fastidious organism predominance (>50%) between the baseline patients and the patients at 3 months and compare the change in prevalence in this taxonomic predominance between the two study groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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