Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)

NCT02213757

Last updated date
Study Location
MedStar Washington Hospital Center
Washington, District of Columbia, 20001, United States
Contact
202 877 6526

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Microscopic Hematuria
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Microscopic HematuriaEffect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
NCT02213757
  1. Washington, District of Columbia
Female
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)
Official Title  ICMJE Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH): A Randomized Controlled Trial [EVER Study]
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Microscopic Hematuria
Intervention  ICMJE
  • Drug: Premarin vaginal estrogen cream
    Other Name: Conjugated estrogens vaginal cream
  • Drug: Placebo vaginal cream
    Inactive vaginal cream manufactured to mimic Premarin vaginal cream
    Other Name: Other names have not been specified
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Premarin vaginal estrogen 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.
    Intervention: Drug: Placebo vaginal cream
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2014)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213757
Other Study ID Numbers  ICMJE 2014-071
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Medstar Health Research Institute
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Cheryl B Iglesia, MDMedstar Washington Hospital Center
Study Director:Lee A Richter, MDMedstar Washington Hospital Center
PRS Account Medstar Health Research Institute
Verification Date March 2016

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