Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 235 for:    PRASTERONE

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02013544
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Vaginal Atrophy
Interventions Drug: Placebo
Drug: Prasterone (DHEA)
Enrollment 558
Recruitment Details A total of 1226 subjects were screened at 38 medical/research sites located in the US (24 centers) and Canada (14 centers) and 558 subjects were randomized. The first subject first visit was on 11-FEB-2014 and the last subject last visit was on 06-JAN-2015.
Pre-assignment Details  
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Period Title: Overall Study
Started 182 376
Safety Population 180 374
ITT Population 157 325
Completed 171 356
Not Completed 11 20
Reason Not Completed
Adverse Event             5             5
Lost to Follow-up             2             3
Withdrawal by Subject             2             8
Physician Decision             0             1
Entry criteria not met/non-compliance             2             3
Arm/Group Title Placebo 0.50% Prasterone (DHEA) Total
Hide Arm/Group Description Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks. Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 180 374 554
Hide Baseline Analysis Population Description
Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of prasterone or placebo, and who have any safety information available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 374 participants 554 participants
59.55  (5.75) 59.51  (6.78) 59.53  (6.46)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 180 participants 374 participants 554 participants
180
 100.0%
374
 100.0%
554
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 374 participants 554 participants
White Caucasian
163
  90.6%
338
  90.4%
501
  90.4%
Black or African American
13
   7.2%
28
   7.5%
41
   7.4%
Asian
2
   1.1%
4
   1.1%
6
   1.1%
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.2%
Native hawaiian or Other Pacific Islander
0
   0.0%
1
   0.3%
1
   0.2%
Other
2
   1.1%
2
   0.5%
4
   0.7%
1.Primary Outcome
Title Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear
Hide Description The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: Percentage of superficial cells
Baseline 1.04  (0.11) 1.02  (0.08)
Week 12 2.78  (0.27) 11.22  (0.56)
Change from Baseline to Week 12 1.75  (0.27) 10.20  (0.57)
2.Primary Outcome
Title Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear
Hide Description The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: Percentage of parabasal cells
Baseline 51.66  (3.00) 54.25  (2.14)
Week 12 39.68  (2.68) 12.74  (1.02)
Change from Baseline to Week 12 -11.98  (2.36) -41.51  (2.01)
3.Primary Outcome
Title Change From Baseline to Week 12 in Vaginal pH
Hide Description A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 6.32  (0.05) 6.34  (0.04)
Week 12 6.05  (0.07) 5.39  (0.05)
Change from Baseline to Week 12 -0.27  (0.06) -0.94  (0.05)
4.Primary Outcome
Title Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia
Hide Description The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.56  (0.04) 2.54  (0.03)
Week 12 1.50  (0.08) 1.13  (0.05)
Change from Baseline to Week 12 -1.06  (0.08) -1.42  (0.06)
5.Secondary Outcome
Title Change From Baseline to Week 12 in Severity of Vaginal Dryness
Hide Description The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe vaginal dryness at Baseline.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 132 273
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.30  (0.04) 2.30  (0.03)
Week 12 1.13  (0.08) 0.86  (0.05)
Change from Baseline to Week 12 -1.17  (0.09) -1.44  (0.06)
6.Secondary Outcome
Title Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions
Hide Description To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.63  (0.05) 2.70  (0.04)
Week 12 2.24  (0.06) 1.97  (0.04)
Change from Baseline to Week 12 -0.39  (0.06) -0.73  (0.04)
7.Secondary Outcome
Title Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity
Hide Description To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.43  (0.06) 2.45  (0.05)
Week 12 2.06  (0.06) 1.75  (0.04)
Change from Baseline to Week 12 -0.37  (0.07) -0.69  (0.05)
8.Secondary Outcome
Title Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness
Hide Description To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.76  (0.05) 2.83  (0.03)
Week 12 2.41  (0.05) 2.09  (0.04)
Change from Baseline to Week 12 -0.36  (0.06) -0.74  (0.05)
9.Secondary Outcome
Title Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color
Hide Description To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description:
Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
Overall Number of Participants Analyzed 157 325
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.67  (0.05) 2.75  (0.03)
Week 12 2.34  (0.05) 2.03  (0.04)
Change from Baseline to Week 12 -0.33  (0.06) -0.73  (0.05)
Time Frame From Baseline to Week 12 (+ 30-day follow-up period after last dose)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 0.50% Prasterone (DHEA)
Hide Arm/Group Description Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks. Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks
All-Cause Mortality
Placebo 0.50% Prasterone (DHEA)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 0.50% Prasterone (DHEA)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   5/374 (1.34%) 
Gastrointestinal disorders     
Colitis ulcerative  1  0/180 (0.00%)  1/374 (0.27%) 
Injury, poisoning and procedural complications     
Post-procedural complication  1  0/180 (0.00%)  1/374 (0.27%) 
Upper limb fracture  1  0/180 (0.00%)  1/374 (0.27%) 
Surgical and medical procedures     
Gastric bypass  1  0/180 (0.00%)  1/374 (0.27%) 
Hernia hiatus repair  1  0/180 (0.00%)  1/374 (0.27%) 
Knee arthroplasty  1  0/180 (0.00%)  1/374 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 0.50% Prasterone (DHEA)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/180 (5.56%)   24/374 (6.42%) 
General disorders     
Application site discharge  1  10/180 (5.56%)  24/374 (6.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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 shall provide to the SPONSOR 30 days prior to submission all documents for publication, presentation, etc that report any trial results. The SPONSOR shall have editorial rights on documents and the right to review/comment with regard to (1) proprietary information, (2) accuracy of the information, (3) correctness of the scientific evaluation/conclusions and (4) to ensure that the information is fairly balanced and in compliance with regulations.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Data Analysis
Organization: Endoceutics
Phone: 418-653-0033 ext 215
EMail: celine.martel@endoceutics.com
Publications of Results:
Layout table for additonal information
Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT02013544     History of Changes
Other Study ID Numbers: ERC-238
First Submitted: December 9, 2013
First Posted: December 17, 2013
Results First Submitted: March 15, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017