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

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT02213757

Collaborator

Pfizer (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 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]

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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 Names: 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 Names: Other names have not been specified

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 Names:

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 Names:

Other names have not been specified

Outcome Measures

Primary Outcome Measures

Resolution of microscopic hematuria [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

Urinary urgency and frequency [8 weeks]
To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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