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Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH) (EVER)

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ClinicalTrials.gov Identifier: NCT02213757
Recruitment Status : Unknown
Verified March 2016 by Medstar Health Research Institute.
Recruitment status was:  Recruiting
First Posted : August 11, 2014
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief Summary:
The purpose of this study is to determine if vaginal estrogen use is associated with resolution of blood in the urine (microscopic hematuria) in postmenopausal women. The hypothesis is that postmenopausal women with blood in the urine (microscopic hematuria) will have higher rates of resolution of hematuria after treatment course with vaginal conjugated equine estrogen cream compared to placebo cream

Condition or disease Intervention/treatment Phase
Microscopic Hematuria Drug: Premarin vaginal estrogen cream Drug: Placebo vaginal cream Phase 4

Detailed Description:

This is a randomized controlled trial of vaginal estrogen cream for postmenopausal women with microscopic hematuria (AMH). Potential subjects will be screened with a dipstick urinalysis of a catheterized urine specimen, followed by microscopic urinalysis and urine culture if urine dipstick is positive for trace blood or greater. Women who are identified as having asymptomatic microscopic hematuria (>3 red blood cells (RBC) per high powered field (hpf)) on a single urine microscopy specimen in the absence of urinary tract infection or other benign cause will be eligible for enrollment.

Women meeting inclusion criteria will be randomized to either conjugated equine estrogen cream (Premarin, 0.625mg conjugated estrogens) or placebo cream for 8 weeks. Microscopic urinalysis of a catheterized urine specimen will be re-checked at 8 weeks to check for reduction, resolution or persistence of AMH. During the 8 weeks of vaginal estrogen or placebo, women will complete the recommended AMH workup as dictated by the American Urologic Association (AUA) guidelines (cystourethroscopy, serum blood urea nitrogen and creatinine levels, and computed tomography (CT) scan of the abdomen and pelvis with and without intravenous contrast).1

Validated questionnaires to assess vaginal atrophy and symptoms of urinary urgency and frequency will be completed at time of randomization and again at 8 weeks. Cost analysis of the standard AMH workup (cystourethroscopy and CT scan) versus empiric treatment with 8 weeks of vaginal estrogen cream will be calculated based on Medicare reimbursement, as well as market price for vaginal estrogen cream Additionally, patients will be asked to complete a questionnaire to assess the level of bother associated with completing the current AMH workup of CT scan and cystoscopy as compared to completing a treatment course of vaginal estrogen cream.

Secondary analyses will determine whether there are additional benefits to a trial period of vaginal estrogen cream in postmenopausal women with AMH prior to reflexively screening for urinary tract abnormalities. We will compare the cost of a standard AMH workup to a treatment course of vaginal estrogen cream, to determine whether vaginal estrogen with potential resolution of AMH is associated with any savings prior to pursuing further workup. Additionally, questionnaires will ask study participants whether they would prefer to undergo the current AUA AMH workup or a treatment course of vaginal cream, in order to assess bother and anxiety associated with these interventions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH): A Randomized Controlled Trial [EVER Study]
Study Start Date : August 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Premarin vaginal cream
Premarin vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.
Drug: Premarin vaginal estrogen cream
Other Name: Conjugated estrogens vaginal cream

Placebo Comparator: Placebo vaginal cream
Placebo vaginal cream to be applied intra-vaginally and to vulva as follows: 1 gram nightly for 2 weeks, followed by 0.5 gram twice weekly for 6 weeks.
Drug: Placebo vaginal cream
Inactive vaginal cream manufactured to mimic Premarin vaginal cream
Other Name: Other names have not been specified




Primary Outcome Measures :
  1. Resolution of microscopic hematuria [ Time Frame: 8 weeks ]
    Microscopic urinalysis will be performed after an 8 week trial of vaginal estrogen or placebo. Resolution of microscopic hematuria is defined according to AUA guidelines, <3 red blood cells per high powered field.


Secondary Outcome Measures :
  1. Urinary urgency and frequency [ Time Frame: 8 weeks ]
    To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-menopausal women
  • Asymptomatic microscopic hematuria (three or more red blood cells per high powered field on a single urine microscopy) in the absence of urinary tract infection.

Exclusion Criteria:

  • Known urologic disease
  • Presence of gross hematuria
  • Presence of indwelling urologic foreign body (foley catheter, ureteral stent)
  • Inability to obtain intravenous contrast CT scan (elevated creatinine, severe contrast allergy)
  • History of pelvic irradiation or malignancy
  • Not a candidate for vaginal estrogen

    • Allergy to vaginal estrogen
    • Current or prior diagnosis of breast or endometrial cancer
    • History of deep vein thrombosis/pulmonary embolus
    • Hypercoagulable state

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): NCT02213757


Contacts
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Contact: Lee A Richter, MD 202 877 6526 Lee.Ann.Richter@medstar.com
Contact: Joanna Peterson 202 877 0526 joanna.l.peterson@medstar.net

Locations
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United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20001
Contact: Lee A Richter, MD    202-877-6526    Lee.Ann.Richter@medstar.net   
Contact: Joanna Peterson    202 877 0526    joanna.l.peterson@medstar.net   
Sub-Investigator: Lee A Richter, MD         
Principal Investigator: Cheryl B Iglesia, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Pfizer
Investigators
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Principal Investigator: Cheryl B Iglesia, MD Medstar Washington Hospital Center
Study Director: Lee A Richter, MD Medstar Washington Hospital Center

Publications of Results:
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02213757     History of Changes
Other Study ID Numbers: 2014-071
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medstar Health Research Institute:
Hematuria
Menopause
Urinalysis
Additional relevant MeSH terms:
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Hematuria
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs