Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 66 of 236 for:    PRASTERONE

Topical DHEA Against Vaginal Atrophy

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: NCT01846442
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : April 28, 2017
Last Update Posted : August 29, 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 (0.25%)
Drug: DHEA (0.5%)
Drug: DHEA (1.0%)
Enrollment 218
Recruitment Details A total of 403 subjects were screened at 8 medical/research sites located in the US (2 centers) and Canada (6 centers) and 218 subjects were randomized. The first subject first visit was on 28-JUN-2007 and the last subject last visit was on 23-MAY-2008.
Pre-assignment Details  
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Period Title: Overall Study
Started 54 54 56 54
Safety Population 54 53 56 54
ITT Population 53 53 56 54
Completed 48 48 52 51
Not Completed 6 6 4 3
Reason Not Completed
Adverse Event             2             4             2             1
Lost to Follow-up             0             0             1             0
Withdrawal by Subject             3             2             0             1
Left the city/Lost medication             1             0             1             1
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA Total
Hide Arm/Group Description Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 54 53 56 54 217
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 54 participants 53 participants 56 participants 54 participants 217 participants
59.00  (5.40) 57.68  (6.31) 58.45  (5.55) 59.44  (4.63) 58.65  (5.50)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 54 participants 53 participants 56 participants 54 participants 217 participants
54
 100.0%
53
 100.0%
56
 100.0%
54
 100.0%
217
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 53 participants 56 participants 54 participants 217 participants
White Caucasian
50
  92.6%
51
  96.2%
54
  96.4%
53
  98.1%
208
  95.9%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   5.6%
1
   1.9%
1
   1.8%
1
   1.9%
6
   2.8%
Other
1
   1.9%
1
   1.9%
1
   1.8%
0
   0.0%
3
   1.4%
1.Primary Outcome
Title Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)
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
The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 26 29 30 29
Mean (Standard Error)
Unit of Measure: percentage of parabasal cells
Baseline 46.7  (8.64) 65.5  (6.92) 53.4  (7.49) 61.8  (6.88)
Week 12 47.8  (7.52) 16.9  (3.66) 11.0  (3.43) 6.90  (1.77)
Change from Baseline 1.1  (3.62) -48.6  (6.78) -42.4  (7.36) -54.9  (6.60)
2.Primary Outcome
Title Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)
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
The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 26 29 30 29
Mean (Standard Error)
Unit of Measure: percentage of superficial cells
Baseline 0.6  (0.2) 0.4  (0.15) 0.4  (0.11) 0.4  (0.16)
Week 12 0.5  (0.19) 5.7  (1.33) 5.2  (1.19) 6.5  (1.53)
Change from Baseline -0.1  (0.23) 5.3  (1.39) 4.8  (1.20) 6.1  (1.54)
3.Primary Outcome
Title Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.
Hide Description A pH strip was applied directly to the lateral wall of the vagina using forceps. 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
The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 26 29 30 29
Mean (Standard Error)
Unit of Measure: pH
Baseline 6.5  (0.13) 6.6  (0.10) 6.6  (0.09) 6.5  (0.11)
Week 12 6.0  (0.22) 5.5  (0.19) 5.2  (0.17) 5.1  (0.12)
Change from Baseline -0.5  (0.16) -1.1  (0.16) -1.5  (0.18) -1.4  (0.15)
4.Primary Outcome
Title Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia
Hide Description The severity of dyspareunia was evaluated by a questionnaire. 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
The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe dyspareunia as their Most Bothersome Symptom of vulvovaginal atrophy (VVA) and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 26 29 30 29
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.8  (0.08) 2.8  (0.08) 2.7  (0.08) 2.6  (0.09)
Week 12 2.3  (0.18) 1.4  (0.22) 1.1  (0.22) 1.2  (0.20)
Change from Baseline -0.4  (0.16) -1.3  (0.20) -1.6  (0.21) -1.4  (0.18)
5.Secondary Outcome
Title Change From Baseline to Week 12 of Vaginal Secretions
Hide Description To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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
The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 53 53 56 54
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 3.1  (0.09) 3.1  (0.09) 3.2  (0.09) 3.0  (0.08)
Week 12 2.7  (0.12) 1.9  (0.10) 1.8  (0.12) 1.5  (0.09)
Change from Baseline -0.4  (0.10) -1.2  (0.12) -1.4  (0.13) -1.4  (0.11)
6.Secondary Outcome
Title Change From Baseline to Week 12 of Vaginal Epithelial Integrity
Hide Description To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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
The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 53 53 56 54
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 2.8  (0.13) 2.7  (0.12) 2.8  (0.11) 2.7  (0.11)
Week 12 2.4  (0.13) 1.7  (0.11) 1.5  (0.10) 1.4  (0.09)
Change from Baseline -0.4  (0.12) -1.0  (0.14) -1.3  (0.12) -1.3  (0.11)
7.Secondary Outcome
Title Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness
Hide Description To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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
The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 53 53 56 54
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 3.0  (0.10) 2.9  (0.08) 3.1  (0.09) 3.0  (0.08)
Week 12 2.6  (0.12) 1.9  (0.11) 1.8  (0.11) 1.6  (0.10)
Change from Baseline -0.4  (0.10) -1.0  (0.12) -1.3  (0.12) -1.4  (0.12)
8.Secondary Outcome
Title Change From Baseline to Week 12 of Vaginal Color
Hide Description To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, 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
The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Overall Number of Participants Analyzed 53 53 56 54
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 3.1  (0.09) 3.0  (0.10) 3.1  (0.09) 3.1  (0.07)
Week 12 2.7  (0.11) 2.0  (0.12) 1.8  (0.11) 1.6  (0.10)
Change from Baseline -0.5  (0.11) -1.0  (0.13) -1.3  (0.14) -1.5  (0.12)
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 0.25% DHEA 0.50% DHEA 1.00% DHEA
Hide Arm/Group Description Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
All-Cause Mortality
Placebo 0.25% DHEA 0.50% DHEA 1.00% DHEA
Affected / at Risk (%) 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 1.00% DHEA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   1/53 (1.89%)   1/56 (1.79%)   0/54 (0.00%) 
Surgical and medical procedures         
Cholecystectomy  1  0/54 (0.00%)  1/53 (1.89%)  0/56 (0.00%)  0/54 (0.00%) 
Appendicetomy  1  0/54 (0.00%)  0/53 (0.00%)  1/56 (1.79%)  0/54 (0.00%) 
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 0.25% DHEA 0.50% DHEA 1.00% DHEA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/54 (62.96%)   32/53 (60.38%)   46/56 (82.14%)   39/54 (72.22%) 
Gastrointestinal disorders         
Abdominal pain  1  4/54 (7.41%)  2/53 (3.77%)  3/56 (5.36%)  5/54 (9.26%) 
General disorders         
Fatigue  1  1/54 (1.85%)  3/53 (5.66%)  4/56 (7.14%)  5/54 (9.26%) 
Infections and infestations         
Nasopharyngitis  1  5/54 (9.26%)  6/53 (11.32%)  4/56 (7.14%)  4/54 (7.41%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  5/54 (9.26%)  2/53 (3.77%)  4/56 (7.14%)  5/54 (9.26%) 
Nervous system disorders         
Headache  1  3/54 (5.56%)  6/53 (11.32%)  6/56 (10.71%)  4/54 (7.41%) 
Reproductive system and breast disorders         
Hot flush  1  4/54 (7.41%)  2/53 (3.77%)  4/56 (7.14%)  4/54 (7.41%) 
Vaginal discharge  1  3/54 (5.56%)  4/53 (7.55%)  6/56 (10.71%)  2/54 (3.70%) 
Vulvovaginal burning sensation  1  4/54 (7.41%)  1/53 (1.89%)  3/56 (5.36%)  4/54 (7.41%) 
Vulvovaginal pruritus  1  3/54 (5.56%)  4/53 (7.55%)  5/56 (8.93%)  5/54 (9.26%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/54 (3.70%)  2/53 (3.77%)  7/56 (12.50%)  1/54 (1.85%) 
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: NCT01846442     History of Changes
Other Study ID Numbers: ERC-210
First Submitted: May 1, 2013
First Posted: May 3, 2013
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: August 29, 2017