Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)

NCT02213757 | Terminated Phase 4 Results

• 1 other identifier: 2014-071
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Microscopic Hematuria

Keywords

Hematuria; Menopause; Urinalysis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Resolution of Microscopic Hematuria

  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.

  8 weeks

Secondary Outcomes (1)

• Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency

  8 weeks

Study Arms (2)

Premarin vaginal cream

EXPERIMENTAL

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

Placebo vaginal cream

PLACEBO COMPARATOR

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

Interventions

Premarin vaginal estrogen cream DRUG

Also known as: Conjugated estrogens vaginal cream

Premarin vaginal cream

Placebo vaginal cream DRUG

Inactive vaginal cream manufactured to mimic Premarin vaginal cream

Also known as: Other names have not been specified

Placebo vaginal cream

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (3)

• Wu JM, Williams KS, Hundley AF, Jannelli ML, Visco AG. Microscopic hematuria as a predictive factor for detecting bladder cancer at cystoscopy in women with irritative voiding symptoms. Am J Obstet Gynecol. 2006 May;194(5):1423-6. doi: 10.1016/j.ajog.2006.01.053. Epub 2006 Mar 30.

  PMID: 16579943 BACKGROUND

• Shalom DF, Lin SN, St Louis S, Lind LR, Winkler HA. The prevalence of microscopic hematuria in women with pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2011 Nov;17(6):290-2. doi: 10.1097/SPV.0b013e3182357afb.

  PMID: 22453223 BACKGROUND

• Jung H, Gleason JM, Loo RK, Patel HS, Slezak JM, Jacobsen SJ. Association of hematuria on microscopic urinalysis and risk of urinary tract cancer. J Urol. 2011 May;185(5):1698-703. doi: 10.1016/j.juro.2010.12.093. Epub 2011 Mar 21.

  PMID: 21419446 BACKGROUND

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Richter
• Organization: MHRI

Lee.Ann.Richter@medstar.net

2028776526

Study Officials

• Cheryl B Iglesia, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

• Lee A Richter, MD

  Medstar Health Research Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 11, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)