Vaginal and Urinary Microbiome Trial

Phase 4

Completed

• Conditions: Menopause; Recurrent Urinary Tract Infections; Atrophic Vaginitis
• Interventions: Drug: Conjugated equine estrogen topical cream; Drug: Apricot kernel oil

• Registration Number: 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.

Study Timeline

• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Study Start: 2017-01
• Primary Completion: 2018-06-30
• Study Completion: 2019-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conjugated equine estrogen topical cream	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.
Apricot kernel oil	Apricot kernel oil	One teaspoonful per vagina every night for 3 months.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Health Care Outpatient Center and Springs Medical Center; 🇺🇸 Louisville, Kentucky, United States