Recruiting

Vaginal Estrogen

Sponsor:

Boston Urogynecology Associates

Code:

NCT03033160

Conditions

Asymptomatic Microscopic Hematuria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Estradiol Ring

Study Details

Brief summary:

The specific aim of this protocol is to determine whether vaginal estrogen is an effective treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators hypothesize that women who use vaginal estrogen for three months will be more likely to have resolution of their asymptomatic microscopic hematuria compared with women who do not use vaginal estrogen.

Conditions

Asymptomatic Microscopic Hematuria

Study ID

NCT03033160

Start date

Dec, 2016

Status verified date

Oct, 2017

Completion date

Dec 30, 2020

Anticipated

Primary completion date

Oct, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Postmenopausal, defined by amenorrhea for at least one year or a bilateral oophorectomy at least one year prior, and have three or more red blood cells per high powered field visible in a properly collected urine specimen without evidence of infection. In addition, women must have a negative cystoscopy and computed tomography urogram (or magnetic resonance urography if history of renal insufficiency or contrast allergy) within the past three years.

Exclusion Criteria:

  • Current or past thromboembolic disorder or cerebrovascular accident
  • Intolerance to previous estrogen replacement therapy or hormone replacement therapy
  • Estrogen dependent neoplasm within the past five years (unless supporting documentation from patient's oncologist is obtained)
  • Estrogen replacement therapy or hormone replacement therapy within the past three months or selective estrogen receptor modulators within eight weeks of enrollment
  • Urinary tract infection
  • Urinary calculi
  • Urinary tract malignancy
  • Vaginal bleeding of unknown origin
  • Urethral caruncle
  • History of recurrent urinary tract infections in the last one year
  • Stage two or greater pelvic organ prolapse.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Estradiol Ring

Estradiol Ring per vagina every 3 months

no intervention: Observation

Observation

Interventions

Estradiol Ring

Primary outcome measure

  • Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kathleen Rogers

614-354-5452krogers2@mah.harvard.edu

Locations

Mount Auburn Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Kathleen Rogers

617-354-5452krogers2@mah.harvard.edu

More Information

Sponsor

Boston Urogynecology Associates

Last update posted

Oct 12, 2017

Last verified

Oct, 2017

Keywords

  • Estrogen
  • Hematuria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Urogynecology Associates on 2017-10-12.