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Vaginal and Urinary Microbiome Trial

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ClinicalTrials.gov Identifier: NCT02869165
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Kate V. Meriwether, 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: Premarin vaginal 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 with 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 Premarin® vaginal cream and a nonhormonal alternative, such as, apricot kernel oil. The participants will be randomized to either Premarin 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  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Premarin vaginal cream
The Premarin vaginal cream 1 gram will be inserted into the vaginal three times were week at nights for 3 months.
Drug: Premarin vaginal 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:
  • Conjugated equine estrogen topical cream
  • Vaginal estrogen cream
  • CEE topical cream

Experimental: Apricot kernel oil
One teaspoonful will be applied per vagina nights 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, to be compared between the control (Premarin® vaginal estrogen) group and apricot kernel oil group. 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, to be compared between the control (Premarin® vaginal estrogen) group and apricot kernel oil group. 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
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-years old
  • Women who qualify for vaginal estrogen
  • Suitability for follow-up

Exclusion Criteria:

  • Age < 18-years old
  • Known allergic reaction or other adverse reactions to Premarin® or any of its components or apricot kernel oil.
  • Inability to apply the treatment as indicated because of other limitations.
  • Already using another form of vaginal estrogen or apricot kernel oil other non-hormonal vaginal moisturizer 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.
  • Chronic antibiotic or probiotic use for indications not listed.
  • Pelvic organ prolapse beyond the hymenal ring.
  • Using a vaginal pessary , vaginal hormonal ring, 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.
  • Recurrent or chronic bacterial vaginosis or recurrent or chronic urinary tract infection 3 episodes with the last year or 2 episodes within the last 6 months.
  • History of deep venous thrombosis or pulmonary embolism or genetic predisposition to thromboembolism.
  • History of an estrogen dependent cancer.
  • Vaginal mesh erosion.
  • Active vulvar dermatoses and on chronic topical steroids.
  • 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


Contacts
Contact: Sherree Goss, RN 1-502-588-4333 skgoss01@louisville.edu
Contact: Deslyn Hobson, M.D. 1-502-561-7260 deslyn.hobson@louisville.edu

Locations
United States, Kentucky
Health Care Outpatient Center and University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Sherree Goss, RN    502-588-4333    skgoss01@louisville.edu   
Principal Investigator: Kate Meriwether, M.D.         
Sub-Investigator: Sean Francis, M.D.         
Sub-Investigator: Deslyn Hobson, M.D.         
Sub-Investigator: Casey Kinman, M.D.         
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Kate Meriwether, M.D. University of Louisville School of Medicine

Additional Information:
Publications of Results:

Responsible Party: Kate V. Meriwether, Assistant Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02869165     History of Changes
Other Study ID Numbers: 16.0428
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Kate V. Meriwether, University of Louisville:
Postmenopausal

Additional relevant MeSH terms:
Urinary Tract Infections
Vaginitis
Atrophic Vaginitis
Infection
Urologic Diseases
Vaginal Diseases
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs