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
|Condition or disease||Intervention/treatment||Phase|
|Microscopic Hematuria||Drug: Premarin vaginal estrogen cream Drug: Placebo vaginal cream||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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.
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
|Contact: Lee A Richter, MD||202 877 6526||Lee.Ann.Richter@medstar.com|
|Contact: Joanna Peterson||202 877 email@example.com|
|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 firstname.lastname@example.org|
|Sub-Investigator: Lee A Richter, MD|
|Principal Investigator: Cheryl B Iglesia, MD|
|Principal Investigator:||Cheryl B Iglesia, MD||Medstar Washington Hospital Center|
|Study Director:||Lee A Richter, MD||Medstar Washington Hospital Center|