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Trial record 2 of 236 for:    PRASTERONE

Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT03854396
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Olivia Cardenas-Trowers, M.D., University of Louisville

Brief Summary:
Urinary tract infections (UTIs) are bothersome and more likely to occur in post-menopausal women. Frequent UTIs, as well as other problems with the urinary and genital systems such as painful sex and urinary frequency/urgency, are part of a symptom complex called genitourinary syndrome of menopause (GSM). Prasterone (Intrarosa®) is a man-made steroid that helps with painful sex in post-menopausal women. Because previous studies have shown prasterone to help with other GSM problems, this study was designed to investigate if prasterone used in the vagina decreases the number of UTIs in post-menopausal women.

Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection Postmenopause Postmenopausal Syndrome Postmenopausal Symptoms Menopause Drug: Prasterone Drug: Placebo Phase 3

Detailed Description:

Urinary tract infections (UTIs) are costly contributing to more than 8 million ambulatory visits (84% women) in the United States in 2007. Recurrent urinary tract infections (rUTIs) are UTIs diagnosed on at least 2 urine cultures in 6 months, or at least 3 in 1 year. The incidence of rUTIs increases in menopause with an estimated 10-15% of women > 60 years old having rUTIs. rUTIs contribute to a constellation of bothersome genitourinary symptoms in some post-menopausal women called genitourinary syndrome of menopause (GSM). Thus, menopause, rUTIs, and GSM are intimately linked.

Prasterone (Intrarosa®) is a synthetic version of the steroid, dehydroepiandrosterone (DHEA), approved by the US Food and Drug Administration in 2016 for the treatment of moderate to severe dyspareunia due to GSM. Large, prospective studies have shown prasterone to safely decrease vaginal pH, decrease parabasal cells, increase superficial cells, and decrease symptoms related to atrophy like dyspareunia in women with GSM. Given prasterone's favorable treatment effects on some GSM symptoms, investigation of prasterone as a possible treatment option for rUTIs in the setting of GSM is warranted.

This is a single center, double-blind, placebo-controlled, randomized trial comparing the efficacy of nightly intravaginal prasterone for 24 weeks to intravaginal placebo in decreasing rUTIs in women with GSM. The study hypothesis is that intravaginal prasterone decreases UTI incidence in women with GSM compared to placebo.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Trial on the Preventive Effect of Intravaginal Prasterone (DHEA, Intrarosa®) on Recurrent Urinary Tract Infections in Women With Genitourinary Syndrome of Menopause
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
Active Comparator: Intravaginal prasterone insert
Nightly intravaginal prasterone insert for 24 weeks
Drug: Prasterone
Nightly intravaginal prasterone insert (6.5 mg prasterone at a concentration of 0.50%) for 24 weeks.
Other Names:
  • Intrarosa
  • Dehydroepiandrosterone
  • DHEA

Placebo Comparator: Intravaginal placebo insert (Witepsol H-15)
Nightly intravaginal placebo insert (Witepsol H-15, a mix of synthetic triglycerides) for 24 weeks
Drug: Placebo
Nightly intravaginal placebo insert (Witepsol H-15, a mix of synthetic triglycerides) for 24 weeks.
Other Names:
  • Witepsol H-15
  • Witepsol




Primary Outcome Measures :
  1. Incidence of urinary tract infections (UTIs) [ Time Frame: 12 weeks ]
    Rate of UTIs during the study with UTI defined as at least one symptom of UTI (eg., dysuria, urinary frequency/urgency/incontinence, hematuria) and at least ≥10^2 colony-forming units (CFUs)/mL of 1 or more uropathogens on urine culture.

  2. Incidence of urinary tract infections (UTIs) [ Time Frame: 24 weeks ]
    Rate of UTIs during the study with UTI defined as at least one symptom of UTI (eg., dysuria, urinary frequency/urgency/incontinence, hematuria) and at least ≥10^2 colony-forming units (CFUs)/mL of 1 or more uropathogens on urine culture.


Secondary Outcome Measures :
  1. Mean days of antibiotic use [ Time Frame: 12 weeks and 24 weeks ]
    Average number of days of antibiotic use for participants in each treatment group who develop a UTI.


Other Outcome Measures:
  1. Change from baseline in treatment response as measured by the vaginal pH [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    pH test strip.

  2. Change from baseline in treatment response as measured by the percentage of parabasal cells in the maturation index of the vaginal smear [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Histological laboratory evaluation.

  3. Change from baseline in treatment response as measured by the percentage of superficial cells in the maturation index of the vaginal smear [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Histological laboratory evaluation.

  4. Change from baseline in treatment response as measured by the percentage of intermediate cells in the maturation index of the vaginal smear [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Histological laboratory evaluation.

  5. Change from baseline in treatment response as measured by the Vulvovaginal Symptom Questionnaire (VSQ) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    21 items with four scales: symptoms, emotions, life impact, and sexual impact. Total scores range: 0-21 (higher scores suggestive of greater severity of symptoms).

  6. Change from baseline in treatment response as measured by the self-reported most bothersome symptom (MBS) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Via a questionnaire, patient rates symptoms of GSM that she experiences. The highest ranked symptom is the patient's MBS.

  7. Change from baseline in treatment response as measured by the Overactive bladder questionnaire (OAB-q) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life).

  8. Change from baseline in treatment response as measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) [ Time Frame: Baseline, 12 weeks, and 24 weeks ]
    Three items on frequency, amount of leakage, and overall impact. Scoring 0-21, higher values indicating increasing severity.

  9. Number of participants with at least one adverse event [ Time Frame: 12 weeks and 24 weeks ]
    Adverse events will only be those determined to be related to the study drug.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 18 years or older who are ≥ 1 year after spontaneous or surgical (bilateral oophorectomy) menopause
  • Presence of ≤ 5% of superficial cells on vaginal smear and vaginal pH > 5.0
  • History of ≥ 2 UTIs in 6 months or ≥ 3 UTIs in 12 months (with the third UTI confirmed on urine culture (and done within the past 1 year)) and negative urine culture prior to treatment randomization

Exclusion Criteria:

  • Known allergy/hypersensitivity to prasterone or its constituents
  • Contraindications to estrogen: acute thrombophlebitis, history of blood clotting disorder, and/or personal history of thromboembolic disorder associated with estrogen use
  • Known or suspected estrogen-dependent neoplasms or mammary, ovarian, cervical, or vaginal malignancies
  • Known congenital urologic or gynecologic abnormality
  • Chronic immunosuppression
  • Need for chronic catheterization
  • Vaginal bleeding of origin other than vaginal mucosal atrophy
  • Vaginal infection requiring treatment
  • Use of systemic hormone replacement therapy or estrogen within past 6 months
  • Use of topical estrogen within past 3 months
  • Consistent use of vaginal products (lubricants, douches)
  • Ongoing antibiotic treatment
  • Ongoing treatment with Lactobacillus
  • Inability to comply with protocol or place vaginal insert with applicator appropriately
  • Less than 3 months status post urinary incontinence and/or pelvic organ prolapse surgery
  • Unable to speak or read English
  • If an exclusion condition is resolved, the patient may be re-approached later for study recruitment (ie., genitourinary infection, use of antibiotics, etc)

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): NCT03854396


Contacts
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Contact: Alyce Goodman-Abraham, A.P.R.N. 502-588-7660 contactus@ulp.org

Locations
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United States, Kentucky
University of Louisville Urogynecology at Springs Medical Center Not yet recruiting
Louisville, Kentucky, United States, 40205
Contact: Alyce Goodman-Abraham, A.P.R.N.    502-588-7660    contactus@ulp.org   
Principal Investigator: Olivia Cardenas-Trowers, M.D.         
Principal Investigator: Sean L Francis, M.D.         
Sponsors and Collaborators
Olivia Cardenas-Trowers, M.D.
AMAG Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Olivia Cardenas-Trowers, M.D. University of Louisville
Principal Investigator: Sean L. Francis, M.D. University of Louisville

Publications:

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Responsible Party: Olivia Cardenas-Trowers, M.D., Fellow Physician in Female Pelvic Medicine & Reconstructive Surgery, University of Louisville
ClinicalTrials.gov Identifier: NCT03854396     History of Changes
Other Study ID Numbers: 19.0075
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available beginning 1 month and ending 24 months following article publication.
Access Criteria: Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.

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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.: Yes
Keywords provided by Olivia Cardenas-Trowers, M.D., University of Louisville:
recurrent urinary tract infection
genitourinary syndrome of menopause
prasterone
Additional relevant MeSH terms:
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Dehydroepiandrosterone
Infection
Communicable Diseases
Urinary Tract Infections
Syndrome
Disease
Pathologic Processes
Urologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs