Vaginal and Urinary Microbiome Trial

May 13, 2021 updated by: Deslyn T. Hobson, University of Louisville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202 and 40205
        • Health Care Outpatient Center and Springs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Vaginal estrogen cream
  • Premarin vaginal 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vaginal symptom questionnaire (VSQ)
Time Frame: 3 months
Change in vaginal symptoms as assessed by vulvovaginal symptom questionnaire (VSQ) at baseline and after treatment.
3 months
Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Deslyn Hobson, M.D., University of Louisville School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

July 31, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16.0428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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