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Trial record 46 of 235 for:    PRASTERONE

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

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: NCT01256684
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : April 25, 2017
Last Update Posted : June 26, 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: DHEA
Enrollment 255
Recruitment Details A total of 464 subjects were screened at 33 medical/research sites located in the US (24 centers) and Canada (9 centers) and 255 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 29-JUL-2011.
Pre-assignment Details  
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description Placebo: Placebo vaginal suppository DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Period Title: Overall Study
Started 81 87 87
Safety Population 80 86 87
ITT Population 77 79 81
Completed 72 74 76
Not Completed 9 13 11
Reason Not Completed
Adverse Event             1             4             2
Withdrawal by Subject             4             0             2
Physician Decision             0             1             0
Lack of Efficacy             0             1             1
Entry criteria not met/non-compliance             4             7             6
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA Total
Hide Arm/Group Description Placebo: Placebo vaginal suppository DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 80 86 87 253
Hide Baseline Analysis Population Description
Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of DHEA or placebo, and who have any safety information available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 86 participants 87 participants 253 participants
58.81  (5.89) 59.37  (6.39) 57.51  (5.63) 58.55  (6.01)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 80 participants 86 participants 87 participants 253 participants
80
 100.0%
86
 100.0%
87
 100.0%
253
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 86 participants 87 participants 253 participants
White Caucasian
69
  86.3%
81
  94.2%
83
  95.4%
233
  92.1%
Black or African American
9
  11.3%
4
   4.7%
3
   3.4%
16
   6.3%
Asian
1
   1.3%
0
   0.0%
1
   1.1%
2
   0.8%
Other
1
   1.3%
1
   1.2%
0
   0.0%
2
   0.8%
1.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 cell 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 the 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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: Percentage of parabasal cells
Baseline 68.48  (4.41) 65.72  (4.56) 65.05  (4.63)
Week 12 66.86  (4.37) 28.43  (3.62) 17.65  (2.87)
Change from Baseline to Week 12 -1.62  (3.22) -37.29  (4.16) -47.40  (4.72)
2.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 cell 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 the 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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: Percentage of superficial cells
Baseline 0.73  (0.15) 0.68  (0.13) 0.68  (0.12)
Week 12 1.64  (0.33) 5.43  (0.57) 6.30  (0.59)
Change from Baseline to Week 12 0.91  (0.31) 4.75  (0.58) 5.62  (0.61)
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 6.51  (0.07) 6.48  (0.07) 6.47  (0.07)
Week 12 6.31  (0.09) 5.70  (0.11) 5.43  (0.10)
Change from Baseline to Week 12 -0.21  (0.08) -0.77  (0.10) -1.04  (0.11)
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.58  (0.06) 2.56  (0.06) 2.63  (0.05)
Week 12 1.71  (0.11) 1.54  (0.12) 1.36  (0.12)
Change from Baseline to Week 12 -0.87  (0.11) -1.01  (0.11) -1.27  (0.11)
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 have self-identified moderate to severe vaginal dryness at Baseline.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 60 70 62
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.33  (0.06) 2.20  (0.05) 2.37  (0.06)
Week 12 1.32  (0.12) 0.91  (0.10) 0.92  (0.10)
Change from Baseline to Week 12 -1.02  (0.14) -1.29  (0.11) -1.45  (0.12)
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 DHEA suppositories, 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 then 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
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.78  (0.08) 2.81  (0.07) 2.83  (0.08)
Week 12 2.36  (0.08) 2.10  (0.09) 1.95  (0.08)
Change from Baseline to Week 12 -0.42  (0.08) -0.71  (0.09) -0.88  (0.11)
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 DHEA suppositories, 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 then 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
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.58  (0.09) 2.57  (0.10) 2.57  (0.10)
Week 12 2.13  (0.09) 1.92  (0.09) 1.69  (0.09)
Change from Baseline to Week 12 -0.45  (0.08) -0.65  (0.09) -0.88  (0.10)
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 DHEA suppositories, 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 then 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
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.91  (0.07) 2.90  (0.08) 2.89  (0.07)
Week 12 2.57  (0.08) 2.32  (0.09) 2.14  (0.08)
Change from Baseline to Week 12 -0.34  (0.07) -0.58  (0.09) -0.75  (0.09)
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 DHEA suppositories, 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 then analyzed using the 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
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository
DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 77 79 81
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.82  (0.08) 2.94  (0.08) 2.94  (0.08)
Week 12 2.56  (0.08) 2.27  (0.10) 2.05  (0.09)
Change from Baseline to Week 12 -0.26  (0.07) -0.67  (0.09) -0.89  (0.10)
Time Frame From Baseline up to 12 Weeks (+ 30-day follow-up period after last dose)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description Placebo: Placebo vaginal suppository DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
All-Cause Mortality
Placebo 0.25% DHEA 0.50% DHEA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 0.25% DHEA 0.50% DHEA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   3/86 (3.49%)   1/87 (1.15%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage  1  0/80 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Hepatobiliary disorders       
Cholecystitis acute  1  0/80 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Infections and infestations       
Bone abscess  1  0/80 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Injury, poisoning and procedural complications       
Thoracic vertebral fracture  1  0/80 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Musculoskeletal and connective tissue disorders       
Kyphosis  1  0/80 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Psychiatric disorders       
Suicidal ideation  1  0/80 (0.00%)  0/86 (0.00%)  1/87 (1.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 0.25% DHEA 0.50% DHEA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/80 (11.25%)   12/86 (13.95%)   10/87 (11.49%) 
General disorders       
Application site discharge  1  5/80 (6.25%)  6/86 (6.98%)  5/87 (5.75%) 
Infections and infestations       
Urinary tract infection  1  4/80 (5.00%)  6/86 (6.98%)  5/87 (5.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Layout table for additonal information
Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT01256684     History of Changes
Other Study ID Numbers: ERC-231
First Submitted: December 3, 2010
First Posted: December 8, 2010
Results First Submitted: March 14, 2017
Results First Posted: April 25, 2017
Last Update Posted: June 26, 2017