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TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy

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ClinicalTrials.gov Identifier: NCT02449902
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
TherapeuticsMD

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Menopause
Vulvovaginal Atrophy
Painful Intercourse
Dyspareunia
Interventions Drug: Estradiol
Drug: placebo
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days. Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
Period Title: Overall Study
Started 24 26
Completed 24 24
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             1
Arm/Group Title Estradiol 10 μg Daily for 14 Days Placebo Daily for 14 Days Total
Hide Arm/Group Description Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days. Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 26 participants 50 participants
62.4  (5.7) 62.3  (7.0) 62.3  (6.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 24 participants 26 participants 50 participants
24 26 50
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.2%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   8.3%
2
   7.7%
4
   8.0%
White
21
  87.5%
24
  92.3%
45
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 26 participants 50 participants
24 26 50
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 24 participants 26 participants 50 participants
26.4  (3.9) 27.2  (3.3) 26.8  (3.6)
1.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)
Hide Description [Not Specified]
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of Parabasal Cells
-54.4  (4.6) -4.8  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells)
Hide Description [Not Specified]
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of Superficial Cells
35.2  (4.7) 8.8  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells)
Hide Description [Not Specified]
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of Intermediate Cells
18.7  (4.7) -3.5  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Vaginal pH
Hide Description [Not Specified]
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: pH
-0.97  (0.1) -0.34  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom
Hide Description The 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.
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.043  (0.2) -1.042  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9951
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity
Hide Description 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.
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
Bleeding/ No Bleeding (Success) 2 1
Bleeding/ Bleeding (Failure) 0 3
No Bleeding/ Bleeding (Failure) 0 1
No Bleeding/ No Bleeding (No Change) 8 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1429
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color)
Hide Description 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).
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one day of study medication.
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.199  (0.1) -0.009  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1945
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Integrity)
Hide Description 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).
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one day of study medication.
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.342  (0.1) 0.176  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Primary Outcome
Title Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Surface Thickness)
Hide Description 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).
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one day of study medication.
Arm/Group Title Treatment 1 Treatment 2
Hide Arm/Group Description:

Estradiol 10 μg vaginal softgel capsule

Estradiol: 1 10 µg capsule inserted vaginally for 14 days.

Placebo vaginal softgel capsule

placebo: 1 placebo capsule inserted vaginally for 14 days.

Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.034  (0.1) -0.133  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment 1, Treatment 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1820
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Primary Outcome
Title Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Secretions)
Hide Description 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).
Time Frame Baseline to 15 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one day of study medication.
Arm/Group Title TX-12-004-HR 10μg Placebo
Hide Arm/Group Description:
Active treatment group.
Control treatment group.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.643  (0.1) -0.274  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TX-12-004-HR 10μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0401
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description Investigators evaluated adverse events for duration, severity, seriousness, causal relationship to the investigational drug and reviewed laboratory assessments per protocol.
 
Arm/Group Title TX-12-004-HR Placebo
Hide Arm/Group Description Active treatment group. Control treatment group.
All-Cause Mortality
TX-12-004-HR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TX-12-004-HR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TX-12-004-HR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/24 (54.17%)   4/26 (15.38%) 
Blood and lymphatic system disorders     
Blood pressure increased  1  1/24 (4.17%)  0/26 (0.00%) 
Eye disorders     
Eye Contusion  1  1/24 (4.17%)  0/26 (0.00%) 
Nervous system disorders     
Paraesthesia  1  0/24 (0.00%)  1/26 (3.85%) 
Renal and urinary disorders     
Nephrolithiasis  1  1/24 (4.17%)  0/26 (0.00%) 
Reproductive system and breast disorders     
Vaginal dysplasia  1  4/24 (16.67%)  0/26 (0.00%) 
Vaginal haemorrhage  1  0/24 (0.00%)  2/26 (7.69%) 
Vulvovaginal discomfort  1  0/24 (0.00%)  1/26 (3.85%) 
Vulvovaginal burning sensation  1  1/24 (4.17%)  0/26 (0.00%) 
Vulvovaginal pruritus  1  1/24 (4.17%)  0/26 (0.00%) 
Vaginal discharge  1  1/24 (4.17%)  0/26 (0.00%) 
Vulvovaginal pain  1  1/24 (4.17%)  0/26 (0.00%) 
Hot flush  1  2/24 (8.33%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shelli Graham, PhD
Organization: TherapeuticsMD
Phone: 561-961-1900
EMail: Shelli.Graham@TherapeuticsMD.com
Layout table for additonal information
Responsible Party: TherapeuticsMD
ClinicalTrials.gov Identifier: NCT02449902     History of Changes
Other Study ID Numbers: TXV13-01
First Submitted: May 18, 2015
First Posted: May 20, 2015
Results First Submitted: July 23, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015