NCT03033160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

October 19, 2016

Last Update Submit

October 11, 2017

Conditions

Asymptomatic Microscopic Hematuria

Keywords

EstrogenHematuria

Outcome Measures

Primary Outcomes (1)

  • Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement

    Investigators will compare red blood cell count results obtained during the initial urinalysis to the 12 week urinalysis to measure any change in red blood cell count (if any).

    12 weeks

Secondary Outcomes (2)

  • Comparison of Microscopic Hematuria (RBC's) at 24 weeks compared to baseline.

    24 weeks

  • To Assess Quality of Life

    12 weeks

Study Arms (2)

Estradiol Ring

EXPERIMENTAL

Estradiol Ring per vagina every 3 months

Drug: Estradiol Ring

Observation

NO INTERVENTION

Observation

Interventions

Estradiol RingDRUG
Also known as: Estring
Estradiol Ring

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

RECRUITING

MeSH Terms

Conditions

Hematuria

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Lekha Hota, MD

    Practitioner

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Rogers

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor Division of Urogynecology and Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

First Submitted

October 19, 2016

First Posted

January 26, 2017

Study Start

December 1, 2016

Primary Completion

October 1, 2019

Study Completion

December 30, 2020

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)