Trial Outcomes & Findings for TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy (NCT NCT02449902)
NCT ID: NCT02449902
Last Updated: 2015-12-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline to 15 days post-treatment
Results posted on
2015-12-14
Participant Flow
Participant milestones
| Measure |
TX-12-004-HR 10μg
Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
|
Placebo
Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
TX-12-004-HR 10μg
Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
|
Placebo
Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy
Baseline characteristics by cohort
| Measure |
Estradiol 10 μg Daily for 14 Days
n=24 Participants
Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
|
Placebo Daily for 14 Days
n=26 Participants
Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
BMI (kg/m^2)
|
26.4 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 3.3 • n=7 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentOutcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)
|
-54.4 Percentage of Parabasal Cells
Standard Error 4.6
|
-4.8 Percentage of Parabasal Cells
Standard Error 4.6
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentOutcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells)
|
35.2 Percentage of Superficial Cells
Standard Error 4.7
|
8.8 Percentage of Superficial Cells
Standard Error 4.7
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentOutcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells)
|
18.7 Percentage of Intermediate Cells
Standard Error 4.7
|
-3.5 Percentage of Intermediate Cells
Standard Error 4.7
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentOutcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Vaginal pH
|
-0.97 pH
Standard Error 0.1
|
-0.34 pH
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentThe severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject.
Outcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom
|
-1.043 units on a scale
Standard Error 0.2
|
-1.042 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentPopulation: Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.
Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.
Outcome measures
| Measure |
TX-12-004-HR 10μg
n=10 Participants
Active treatment group.
|
Placebo
n=10 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity
Bleeding/ No Bleeding (Success)
|
2 participants
|
1 participants
|
|
Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity
Bleeding/ Bleeding (Failure)
|
0 participants
|
3 participants
|
|
Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity
No Bleeding/ Bleeding (Failure)
|
0 participants
|
1 participants
|
|
Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity
No Bleeding/ No Bleeding (No Change)
|
8 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentPopulation: All participants receiving at least one day of study medication.
Outcome was measured by using a severity scale. No Atrophy is pink in color (0). Mild atrophy is lighter in color (1). Moderate atrophy is pale in color (2). Severe atrophy is transparent, either no color or inflamed (3).
Outcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color)
|
-0.199 units on a scale
Standard Error 0.1
|
-0.009 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentPopulation: All participants receiving at least one day of study medication.
Outcome was measured by using a severity scale. No Atrophy=normal(0). Mild atrophy=vaginal surface bleeds with scraping(1). Moderate atrophy=vaginal surface bleeds with light contact(2). Severe atrophy=vaginal surface has petechiae before contact and bleeds with light contact(3).
Outcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Integrity)
|
-0.342 units on a scale
Standard Error 0.1
|
0.176 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentPopulation: All participants receiving at least one day of study medication.
Outcome was measured by using a severity scale. No Atrophy has rogation and elasticity of vault(0). Mild atrophy has poor rogation with some elasticity noted of vaginal vault(1). Moderate atrophy is smooth, some elasticity of vaginal vault(2). Severe atrophy is smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)(3).
Outcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Surface Thickness)
|
-0.034 units on a scale
Standard Error 0.1
|
-0.133 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Baseline to 15 days post-treatmentPopulation: All participants receiving at least one day of study medication.
Outcome was measured by using a severity scale. No Atrophy has normal clear secretions noted on vaginal walls(0). Mild atrophy has superficial coating of secretions, difficulty with speculum insertion(1). Moderate atrophy is scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain(2). Severe atrophy has none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain(3).
Outcome measures
| Measure |
TX-12-004-HR 10μg
n=24 Participants
Active treatment group.
|
Placebo
n=24 Participants
Control treatment group.
|
|---|---|---|
|
Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Secretions)
|
-0.643 units on a scale
Standard Error 0.1
|
-0.274 units on a scale
Standard Error 0.1
|
Adverse Events
TX-12-004-HR
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TX-12-004-HR
n=24 participants at risk
Active treatment group.
|
Placebo
n=26 participants at risk
Control treatment group.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood pressure increased
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Eye disorders
Eye Contusion
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
3.8%
1/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vaginal dysplasia
|
16.7%
4/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
7.7%
2/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
3.8%
1/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
4.2%
1/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
|
Reproductive system and breast disorders
Hot flush
|
8.3%
2/24 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
0.00%
0/26 • Adverse events were collected for 14 days (study duration). Subjects with AEs that were ongoing at study completion or study withdrawal were followed until resolution or for 30 days after the last dose of study medication.
Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators may publish their own data provided that the information is reviewed by the Sponsor. Otherwise, publication of the outcome and results of the study will be the sole domain of Sponsor, and publication of the study results by the Institution or Principal Investigator is not permitted, except with the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER