ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

July 31, 2016
August 16, 2016
April 28, 2017
January 2017
January 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02869165 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Vaginal and Urinary Microbiome Trial
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
  • Atrophic Vaginitis
  • Menopause
  • Recurrent Urinary Tract Infections
  • 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
  • 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
  • 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.
    Intervention: Drug: Premarin vaginal cream
  • Experimental: Apricot kernel oil
    One teaspoonful will be applied per vagina nights for 3 months.
    Intervention: Drug: Apricot kernel oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
94
Same as current
May 2018
January 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Yes
Contact: Sherree Goss, RN 1-502-588-4333 skgoss01@louisville.edu
Contact: Deslyn Hobson, M.D. 1-502-561-7260 deslyn.hobson@louisville.edu
United States
 
 
NCT02869165
16.0428
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
Plan to Share IPD: No
Kate V. Meriwether, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Kate Meriwether, M.D. University of Louisville School of Medicine
University of Louisville
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP