Trial Outcomes & Findings for Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH) (NCT NCT02213757)

Last Updated: 2023-03-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	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. Premarin vaginal estrogen cream	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. Placebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream
Overall Study STARTED	15	14
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Vaginal Estrogen on Asymptomatic Microhematuria (AMH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Premarin Vaginal Cream n=15 Participants 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. Premarin vaginal estrogen cream	Placebo Vaginal Cream n=14 Participants 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. Placebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=113 Participants	7 Participants n=163 Participants	15 Participants n=160 Participants
Age, Categorical >=65 years	7 Participants n=113 Participants	7 Participants n=163 Participants	14 Participants n=160 Participants
Sex: Female, Male Female	15 Participants n=113 Participants	14 Participants n=163 Participants	29 Participants n=160 Participants
Sex: Female, Male Male	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	1 Participants n=113 Participants	1 Participants n=163 Participants	2 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Black or African American	6 Participants n=113 Participants	5 Participants n=163 Participants	11 Participants n=160 Participants
Race (NIH/OMB) White	4 Participants n=113 Participants	6 Participants n=163 Participants	10 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=113 Participants	2 Participants n=163 Participants	5 Participants n=160 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: There were 14 participants in Placebo arm, 10 completed study and 4 were lost to follow up. 6 in Placebo group had resolution of microhematuria. There were 15 participants in Estrogen arm, 10 completed study and 5 were lost to follow up. 10 in Estrogen group had resolution of microhematuria.

Outcome measures

Outcome measures
Measure	Premarin Vaginal Cream n=10 Participants 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. Premarin vaginal estrogen cream	Placebo Vaginal Cream n=10 Participants 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. Placebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream
Number of Participants With Resolution of Microscopic Hematuria	10 participants	6 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: OAB-q scores were collected at baseline and at follow-up. Subjects with at least one point reduction in OAB-q score were recorded to show improvement in OAB-q score. Seven participants in the test group showed a reduction of at least 1 point and seven participants in the control group showed a reduction of at least 1 point.

To determine the effect of vaginal estrogen compared to placebo on symptoms of urinary frequency and urgency. Participants that experience at least one point reduction in OAB-q score will qualify as a participant with improvement in these symptoms.

Outcome measures

Outcome measures
Measure	Premarin Vaginal Cream n=10 Participants 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. Premarin vaginal estrogen cream	Placebo Vaginal Cream n=10 Participants 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. Placebo vaginal cream: Inactive vaginal cream manufactured to mimic Premarin vaginal cream
Number of Participants With Improvement in Symptoms of Urinary Frequency and Urgency	7 Participants	7 Participants

Adverse Events

Premarin Vaginal Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Vaginal Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richter

MHRI

Phone: 2028776526

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place