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Trial record 17 of 235 for:    PRASTERONE

Dehydroepiandrosterone (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: NCT01358760
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : June 12, 2017
Last Update Posted : June 12, 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 450
Recruitment Details A total of 897 subjects were screened at 42 medical/research sites located in the US (32 centers) and Canada (10 centers) and 450 subjects were randomized. The first subject first visit was on 21-JUN-2011 and the last subject last visit was on 12-APR-2012.
Pre-assignment Details  
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Period Title: Overall Study
Started 152 148 150
Safety Population 150 143 148
ITT Population 139 134 134
Completed 130 128 125
Not Completed 22 20 25
Reason Not Completed
Adverse Event             3             4             3
Lost to Follow-up             1             1             3
Withdrawal by Subject             5             3             2
Physician Decision             1             0             1
Entry criteria not met/Non-compliance             12             12             16
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA Total
Hide Arm/Group Description Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. Total of all reporting groups
Overall Number of Baseline Participants 150 143 148 441
Hide Baseline Analysis Population Description
Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of DHEA (prasterone) or placebo, and who have any safety information available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 143 participants 148 participants 441 participants
57.59  (6.47) 58.41  (6.02) 58.33  (6.16) 58.11  (6.22)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 150 participants 143 participants 148 participants 441 participants
150
 100.0%
143
 100.0%
148
 100.0%
441
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 143 participants 148 participants 441 participants
White caucasian
135
  90.0%
132
  92.3%
131
  88.5%
398
  90.2%
Black or African American
12
   8.0%
9
   6.3%
13
   8.8%
34
   7.7%
Asian
1
   0.7%
1
   0.7%
1
   0.7%
3
   0.7%
American Indian or Alaska Native
1
   0.7%
0
   0.0%
0
   0.0%
1
   0.2%
Other
1
   0.7%
1
   0.7%
3
   2.0%
5
   1.1%
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 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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: percentage of parabasal cells
Baseline 60.66  (3.40) 56.74  (3.69) 59.54  (3.41)
Week 12 62.22  (3.49) 39.23  (3.15) 33.02  (3.09)
Change from Baseline to Week 12 1.56  (1.98) -17.51  (2.74) -26.52  (2.94)
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 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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: percentage of superficial cells
Baseline 0.97  (0.13) 1.12  (0.13) 0.93  (0.11)
Week 12 1.80  (0.29) 3.43  (0.34) 3.58  (0.41)
Change from Baseline to Week 12 0.83  (0.26) 2.31  (0.32) 2.66  (0.41)
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; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: pH units
Baseline 6.34  (0.05) 6.27  (0.06) 6.29  (0.06)
Week 12 6.06  (0.08) 5.69  (0.09) 5.67  (0.08)
Change from Baseline to Week 12 -0.28  (0.06) -0.58  (0.07) -0.62  (0.07)
4.Primary Outcome
Title Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness
Hide Description The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of 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 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; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.38  (0.04) 2.37  (0.04) 2.35  (0.04)
Week 12 1.27  (0.07) 1.10  (0.07) 1.13  (0.08)
Change from Baseline to Week 12 -1.12  (0.08) -1.28  (0.08) -1.22  (0.08)
5.Secondary Outcome
Title Change From Baseline to Week 12 in Severity 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 on dyspareunia were performed on a subgroup 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 dyspareunia at Baseline.
Arm/Group Title Placebo 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 99 93 100
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.56  (0.05) 2.58  (0.05) 2.60  (0.05)
Week 12 1.78  (0.11) 1.48  (0.12) 1.54  (0.10)
Change from Baseline to Week 12 -0.78  (0.10) -1.10  (0.12) -1.06  (0.10)
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.71  (0.05) 2.55  (0.06) 2.55  (0.06)
Week 12 2.33  (0.06) 2.07  (0.08) 2.07  (0.06)
Change from Baseline to Week 12 -0.38  (0.05) -0.48  (0.08) -0.48  (0.07)
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.32  (0.07) 2.19  (0.07) 2.19  (0.08)
Week 12 1.94  (0.07) 1.74  (0.07) 1.69  (0.07)
Change from Baseline to Week 12 -0.38  (0.06) -0.46  (0.07) -0.50  (0.08)
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.78  (0.06) 2.66  (0.06) 2.72  (0.06)
Week 12 2.40  (0.07) 2.25  (0.07) 2.16  (0.06)
Change from Baseline to Week 12 -0.38  (0.06) -0.40  (0.07) -0.56  (0.07)
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 0.25% DHEA 0.50% DHEA
Hide Arm/Group Description:
Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Overall Number of Participants Analyzed 139 134 134
Mean (Standard Error)
Unit of Measure: Severity score
Baseline 2.66  (0.05) 2.60  (0.06) 2.65  (0.06)
Week 12 2.31  (0.07) 2.16  (0.07) 2.12  (0.06)
Change from Baseline to Week 12 -0.35  (0.06) -0.45  (0.07) -0.53  (0.07)
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
Hide Arm/Group Description Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks. DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 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   5/150 (3.33%)   1/143 (0.70%)   1/148 (0.68%) 
Gastrointestinal disorders       
Gastritis erosive  1  1/150 (0.67%)  0/143 (0.00%)  0/148 (0.00%) 
Pancreatitis  1  1/150 (0.67%)  0/143 (0.00%)  0/148 (0.00%) 
Small intestinal obstruction  1  1/150 (0.67%)  0/143 (0.00%)  0/148 (0.00%) 
Infections and infestations       
Cellulitis  1  0/150 (0.00%)  0/143 (0.00%)  1/148 (0.68%) 
Nervous system disorders       
Movement disorder  1  0/150 (0.00%)  1/143 (0.70%)  0/148 (0.00%) 
Psychiatric disorders       
Stress  1  1/150 (0.67%)  0/143 (0.00%)  0/148 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/150 (0.67%)  0/143 (0.00%)  0/148 (0.00%) 
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   19/150 (12.67%)   17/143 (11.89%)   23/148 (15.54%) 
Infections and infestations       
Nasopharyngitis  1  10/150 (6.67%)  7/143 (4.90%)  9/148 (6.08%) 
Urinary tract infection  1  9/150 (6.00%)  10/143 (6.99%)  14/148 (9.46%) 
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: NCT01358760     History of Changes
Other Study ID Numbers: ERC-234
First Submitted: May 20, 2011
First Posted: May 24, 2011
Results First Submitted: March 17, 2017
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017