Trial Outcomes & Findings for Preventing Recurrent UTI With Vaginal Estrogen (NCT NCT05551949)

Results Overview

Changes to relative vaginal abundance of key Lactobacillus spp. before and after treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2026-03-05

Participant Flow

Twenty-seven participants signed informed consent. Two participants never started the study. Twenty-five participants were assigned to the treatment arm of the study.

Participant milestones

Participant milestones
Measure	Vaginal Estrogen Therapy Participants receive Vaginal estrogen therapy.
Overall Study STARTED	25
Overall Study First 12 Weeks of Therapy	25
Overall Study 2nd 12 Weeks of Therapy	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vaginal Estrogen Therapy Participants receive Vaginal estrogen therapy.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Preventing Recurrent UTI With Vaginal Estrogen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vaginal Estrogen Therapy n=25 Participants Participants receive Vaginal estrogen therapy.
Age, Continuous	68 years n=41 Participants
Sex: Female, Male Female	25 Participants n=41 Participants
Sex: Female, Male Male	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	1 Participants n=41 Participants
Race (NIH/OMB) White	23 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants
Region of Enrollment United States	25 Participants n=41 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Changes to relative vaginal abundance of key Lactobacillus spp. before and after treatment.

Outcome measures

Outcome measures
Measure	Vaginal Estrogen Therapy n=25 Participants Participants receive Vaginal estrogen therapy.
Change in Vaginal Microbiota	2.75 change in percent relative abundance Interval -1.09 to 47.07

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: For one participant, the concentration of IL-6 was below the lower limit of detection at 12 weeks.

Changes to vaginal Interleukin-6 before and after treatment.

Outcome measures

Outcome measures
Measure	Vaginal Estrogen Therapy n=24 Participants Participants receive Vaginal estrogen therapy.
Change in Vaginal Interleukin-6 Level	-58.66 change in concentration (fg/ML) Interval -799.3 to 732.28

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Of 25 participants, urine from 5 did not yield taxonomy data at either time-point. (Samples with fewer than 250 reads were removed from analysis.) Urine from an additional 7 participants could be sequenced at only one time-point (3 at enrollment and 4 after 12 weeks). Therefore, the outcome related to "Changes to relative urinary abundance of key Lactobacillus spp. before and after treatment" was available for only 13 participants.

Changes to relative urinary abundance of key Lactobacillus spp. before and after treatment.

Outcome measures

Outcome measures
Measure	Vaginal Estrogen Therapy n=13 Participants Participants receive Vaginal estrogen therapy.
Change in Urinary Microbiota	-3.50 change in percent relative abundance Interval -24.87 to 1.3

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Changes to urinary Interleukin-6 before and after treatment.

Outcome measures

Outcome measures
Measure	Vaginal Estrogen Therapy n=25 Participants Participants receive Vaginal estrogen therapy.
Change in Urinary Interleukin-6 Level	-476.10 change in concentration (fg/ML) Interval -1145.52 to 1113.53

SECONDARY outcome

Timeframe: Weeks 12 to 24

Population: One participant left the study at 12 weeks and therefore did not provide data for the period of time relevant to this measure.

Participants with at least one occurrence of symptomatic UTI after at least 12 weeks of therapy.

Outcome measures

Outcome measures
Measure	Vaginal Estrogen Therapy n=24 Participants Participants receive Vaginal estrogen therapy.
Urinary Tract Infection Recurrence	7 Participants

Adverse Events

Vaginal Estrogen Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vaginal Estrogen Therapy n=25 participants at risk Participants receive Vaginal estrogen therapy.
Vascular disorders Deep venous thrombosis	4.0% 1/25 • From enrollment through 24 weeks

Additional Information

Victoria Handa MD

Johns Hopkins University School of Medicine

Phone: 410-550-0336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place