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Vaginal and Urinary Microbiome Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02869165
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Deslyn T. Hobson, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be genetically female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869165


Locations
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United States, Kentucky
Health Care Outpatient Center and Springs Medical Center
Louisville, Kentucky, United States, 40202 and 40205
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Deslyn Hobson, M.D. University of Louisville School of Medicine
Additional Information:
Publications of Results:

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Responsible Party: Deslyn T. Hobson, Fellow Female Pelvic Medicine and Reconstructive Surgery, University of Louisville
ClinicalTrials.gov Identifier: NCT02869165    
Other Study ID Numbers: 16.0428
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Deslyn T. Hobson, University of Louisville:
Postmenopausal
Additional relevant MeSH terms:
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Urinary Tract Infections
Vaginitis
Atrophic Vaginitis
Infections
Urologic Diseases
Vaginal Diseases
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs