Trial Outcomes & Findings for Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA (NCT NCT05378269)

NCT ID: NCT05378269

Last Updated: 2024-10-21

Results Overview

to evaluate the safety and tolerability of DARE-VVA1 by intravaginal administration

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

56 days

Results posted on

2024-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg vaginal insert Tamoxifen: Tamoxifen vaginal insert
Overall Study STARTED	4	3	4	3	3
Overall Study COMPLETED	3	3	2	3	3
Overall Study NOT COMPLETED	1	0	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg vaginal insert Tamoxifen: Tamoxifen vaginal insert
Overall Study Protocol Violation	1	0	2	0	0

Baseline Characteristics

Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=4 Participants Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg n=4 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=39 Participants	1 Participants n=41 Participants	4 Participants n=35 Participants	2 Participants n=31 Participants	2 Participants n=146 Participants	12 Participants n=19 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants	2 Participants n=41 Participants	0 Participants n=35 Participants	1 Participants n=31 Participants	1 Participants n=146 Participants	5 Participants n=19 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 5.38 • n=39 Participants	65.7 years STANDARD_DEVIATION 1.53 • n=41 Participants	59.3 years STANDARD_DEVIATION 2.99 • n=35 Participants	57.7 years STANDARD_DEVIATION 8.08 • n=31 Participants	61.3 years STANDARD_DEVIATION 4.16 • n=146 Participants	60.9 years STANDARD_DEVIATION 4.97 • n=19 Participants
Sex: Female, Male Female	4 Participants n=39 Participants	3 Participants n=41 Participants	4 Participants n=35 Participants	3 Participants n=31 Participants	3 Participants n=146 Participants	17 Participants n=19 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=39 Participants	3 Participants n=41 Participants	4 Participants n=35 Participants	3 Participants n=31 Participants	3 Participants n=146 Participants	17 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) White	4 Participants n=39 Participants	3 Participants n=41 Participants	4 Participants n=35 Participants	3 Participants n=31 Participants	3 Participants n=146 Participants	17 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Region of Enrollment Australia	4 participants n=39 Participants	3 participants n=41 Participants	4 participants n=35 Participants	3 participants n=31 Participants	3 participants n=146 Participants	17 participants n=19 Participants
Body Mass Index	25.03 kg/m^2 STANDARD_DEVIATION 5.287 • n=39 Participants	26.04 kg/m^2 STANDARD_DEVIATION 4.869 • n=41 Participants	26.58 kg/m^2 STANDARD_DEVIATION 5.486 • n=35 Participants	24.67 kg/m^2 STANDARD_DEVIATION 2.219 • n=31 Participants	23.70 kg/m^2 STANDARD_DEVIATION 3.676 • n=146 Participants	25.27 kg/m^2 STANDARD_DEVIATION 4.151 • n=19 Participants

PRIMARY outcome

Timeframe: 56 days

to evaluate the safety and tolerability of DARE-VVA1 by intravaginal administration

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg n=4 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert
Number of Subjects With Treatment Emergent Adverse Events	3 Participants	2 Participants	4 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 56 days

Population: Placebo users were not using Tamoxifen so a correlation between Tamoxifen and vaginal pH was not performed.

to determine the plasma concentrations of tamoxifen after intravaginal administration

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg n=2 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert
Concentration of Tamoxifen in Serial Plasma Collections (Cmax)	0 ng/mL Geometric Coefficient of Variation 0	0.181 ng/mL Geometric Coefficient of Variation 32.21	1.93 ng/mL Geometric Coefficient of Variation 46.62	3.29 ng/mL Geometric Coefficient of Variation 12.01	5.50 ng/mL Geometric Coefficient of Variation 31.54

SECONDARY outcome

Timeframe: 56 days

Population: We were looking at a correlation between Tamoxifen and parabasal cells. Placebo users were not exposed to Tamoxifen.

to analyze the change from baseline to end of study of percentage of parabasal cells

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg n=2 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert
Evaluation of Vaginal Cytology	0 % parabasal cells Interval 0.0 to 0.0	-12.0 % parabasal cells Interval -15.0 to -5.0	-22.5 % parabasal cells Interval -45.0 to 0.0	-69.0 % parabasal cells Interval -98.0 to -61.0	-94.0 % parabasal cells Interval -100.0 to -4.0

SECONDARY outcome

Timeframe: 56 days

to analyze preliminary efficacy and pharmacodynamics of DARE-VVA1 by looking at change in baseline of vaginal pH from Day 1 to Day 56

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg n=2 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert
Evaluation of Vaginal pH	-0.3 pH Standard Deviation 0.95	-0.3 pH Standard Deviation 0.31	-0.3 pH Standard Deviation 0.42	-0.3 pH Standard Deviation 0.70	-0.7 pH Standard Deviation 0.72

SECONDARY outcome

Timeframe: 56 days

Population: We were looking at a correlation between Tamoxifen and superficial cells. Placebo users were not exposed to Tamoxifen.

to analyze the change from baseline to end of study of percentage of superficial cells

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Vaginal insert Placebo: Placebo vaginal insert	DARE-VVA1 1mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 5mg n=4 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 10mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert	DARE-VVA1 20mg n=3 Participants vaginal insert Tamoxifen: Tamoxifen vaginal insert
Evaluation of Vaginal Cytology	0 % superficial cells Interval 0.0 to 0.0	-3.0 % superficial cells Interval -4.0 to -2.0	8.5 % superficial cells Interval 2.0 to 15.0	6.0 % superficial cells Interval 1.0 to 14.0	52.3 % superficial cells Interval 18.0 to 85.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 56 days

to analyze the impact of DARE-VVA1 on quality of life following treatment evaluated by total questionnaire score; looking for a decreased in total score.