Vaginal and Urinary Microbiome Trial

NCT02869165 | Completed Phase 4 FDA Drug

• 1 other identifier: 16.0428
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophic Vaginitis; Menopause; Recurrent Urinary Tract Infections

Keywords

Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.

  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 Outcomes (2)

• Change in vaginal symptom questionnaire (VSQ)

  3 months

• Vaginal and urinary predominance of anaerobic/fastidious taxonomy of micro-organisms on genomic, microbial DNA analysis of vaginal and urinary specimens.

  3 months

Study Arms (2)

Conjugated equine estrogen topical cream

EXPERIMENTAL

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

Apricot kernel oil

EXPERIMENTAL

One teaspoonful per vagina every night for 3 months.

Drug: Apricot kernel oil

Interventions

Conjugated equine estrogen topical cream DRUG

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.

Also known as: Premarin vaginal cream, Vaginal estrogen cream, CEE topical cream

Conjugated equine estrogen topical cream

Apricot kernel oil DRUG

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.

Also known as: Natural oil, Organic oil

Apricot kernel oil

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be genetically female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Health Care Outpatient Center and Springs Medical Center

Louisville, Kentucky, 40202 and 40205, United States

Location

Related Publications (21)

• Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.

  PMID: 23985562 RESULT

• Parish SJ, Nappi RE, Krychman ML, Kellogg-Spadt S, Simon JA, Goldstein JA, Kingsberg SA. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int J Womens Health. 2013 Jul 29;5:437-47. doi: 10.2147/IJWH.S44579. Print 2013.

  PMID: 23935388 RESULT

• Danforth KN, Townsend MK, Lifford K, Curhan GC, Resnick NM, Grodstein F. Risk factors for urinary incontinence among middle-aged women. Am J Obstet Gynecol. 2006 Feb;194(2):339-45. doi: 10.1016/j.ajog.2005.07.051.

  PMID: 16458626 RESULT

• Nachtigall LE. Comparative study: Replens versus local estrogen in menopausal women. Fertil Steril. 1994 Jan;61(1):178-80. doi: 10.1016/s0015-0282(16)56474-7.

  PMID: 8293835 RESULT

• Siddiqui H, Nederbragt AJ, Lagesen K, Jeansson SL, Jakobsen KS. Assessing diversity of the female urine microbiota by high throughput sequencing of 16S rDNA amplicons. BMC Microbiol. 2011 Nov 2;11:244. doi: 10.1186/1471-2180-11-244.

  PMID: 22047020 RESULT

• Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001500. doi: 10.1002/14651858.CD001500.pub2.

  PMID: 17054136 RESULT

• Lamont RF, Sobel JD, Akins RA, Hassan SS, Chaiworapongsa T, Kusanovic JP, Romero R. The vaginal microbiome: new information about genital tract flora using molecular based techniques. BJOG. 2011 Apr;118(5):533-49. doi: 10.1111/j.1471-0528.2010.02840.x. Epub 2011 Jan 20.

  PMID: 21251190 RESULT

• Hummelen R, Macklaim JM, Bisanz JE, Hammond JA, McMillan A, Vongsa R, Koenig D, Gloor GB, Reid G. Vaginal microbiome and epithelial gene array in post-menopausal women with moderate to severe dryness. PLoS One. 2011;6(11):e26602. doi: 10.1371/journal.pone.0026602. Epub 2011 Nov 2.

  PMID: 22073175 RESULT

• Martin DH. The microbiota of the vagina and its influence on women's health and disease. Am J Med Sci. 2012 Jan;343(1):2-9. doi: 10.1097/MAJ.0b013e31823ea228.

  PMID: 22143133 RESULT

• Bygdeman M, Swahn ML. Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women. Maturitas. 1996 Apr;23(3):259-63. doi: 10.1016/0378-5122(95)00955-8.

  PMID: 8794418 RESULT

• Coyne KS, Margolis MK, Thompson C, Kopp Z. Psychometric equivalence of the OAB-q in Danish, German, Polish, Swedish, and Turkish. Value Health. 2008 Dec;11(7):1096-101. doi: 10.1111/j.1524-4733.2008.00346.x. Epub 2008 May 16.

  PMID: 18489500 RESULT

• Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kammerer-Doak DN, Pauls RN, Parekh M, Ridgeway B, Jha S, Pitkin J, Reid F, Sutherland SE, Lukacz ES, Domoney C, Sand P, Davila GW, Espuna Pons ME. A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1091-103. doi: 10.1007/s00192-012-2020-8. Epub 2013 Apr 30.

  PMID: 23632798 RESULT

• Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.

  PMID: 11166145 RESULT

• Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61. doi: 10.1016/j.ajog.2006.01.060.

  PMID: 16647928 RESULT

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 RESULT

• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.

  PMID: 12861145 RESULT

• Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.

  PMID: 19252451 RESULT

• Levine KB, Williams RE, Hartmann KE. Vulvovaginal atrophy is strongly associated with female sexual dysfunction among sexually active postmenopausal women. Menopause. 2008 Jul-Aug;15(4 Pt 1):661-6. doi: 10.1097/gme.0b013e31815a5168.

  PMID: 18698279 RESULT

• Rahn DD, Carberry C, Sanses TV, Mamik MM, Ward RM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen for genitourinary syndrome of menopause: a systematic review. Obstet Gynecol. 2014 Dec;124(6):1147-1156. doi: 10.1097/AOG.0000000000000526.

  PMID: 25415166 RESULT

• Rahn DD, Ward RM, Sanses TV, Carberry C, Mamik MM, Meriwether KV, Olivera CK, Abed H, Balk EM, Murphy M; Society of Gynecologic Surgeons Systematic Review Group. Vaginal estrogen use in postmenopausal women with pelvic floor disorders: systematic review and practice guidelines. Int Urogynecol J. 2015 Jan;26(1):3-13. doi: 10.1007/s00192-014-2554-z. Epub 2014 Nov 13.

  PMID: 25392183 RESULT

• Erekson EA, Yip SO, Wedderburn TS, Martin DK, Li FY, Choi JN, Kenton KS, Fried TR. The Vulvovaginal Symptoms Questionnaire: a questionnaire for measuring vulvovaginal symptoms in postmenopausal women. Menopause. 2013 Sep;20(9):973-9. doi: 10.1097/GME.0b013e318282600b.

  PMID: 23481118 RESULT

Related Links

• Organization for Economic Cooperation and Development. Health at a glance 2013: OECD indicators.

MeSH Terms

Conditions

Atrophic Vaginitis; Urinary Tract Infections

Interventions

Oil and Gas Industry

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infections; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Extraction and Processing Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture

Study Officials

• Deslyn Hobson, M.D.

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: August 16, 2016
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2019
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)