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DHEA Against Vaginal Atrophy - Safety Study of 12 Months

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ClinicalTrials.gov Identifier: NCT01256671
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vaginal Atrophy
Intervention Drug: DHEA
Enrollment 530
Recruitment Details A total of 798 subjects were screened at 41 medical/research sites located in the US (31 centers) and Canada (10 centers) and 530 subjects were randomized. The first subject first visit was on 30-NOV-2010 and the last subject last visit was on 16-JUL-2012.
Pre-assignment Details  
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Period Title: Overall Study
Started 530
Safety Population 521
Completed 435
Not Completed 95
Reason Not Completed
Adverse Event             29
Lost to Follow-up             16
Withdrawal by Subject             31
Physician Decision             3
Lack of Efficacy             4
Non-compliance/Sponsor Decision/Other             12
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Baseline Participants 521
Hide Baseline Analysis Population Description
Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of DHEA, and who have any safety information available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 521 participants
57.95  (5.65)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 521 participants
521
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants
White Caucasian
478
  91.7%
Black or African American
31
   6.0%
Asian
3
   0.6%
American Indian or Alaska Native
3
   0.6%
Native Hawaiian or Other Pacific Islander
2
   0.4%
Other
4
   0.8%
1.Primary Outcome
Title Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium
Hide Description The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.
Time Frame Baseline and Week 52 (or discontinuation)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis.
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 457
Measure Type: Count of Participants
Unit of Measure: Participants
Endometrium: Atrophic/Inactive
421
  92.1%
Endometrium: No/Insufficient Tissue for Diagnosis
36
   7.9%
2.Primary Outcome
Title Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels
Hide Description The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52.
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 429
Mean (Standard Error)
Unit of Measure: pg/mL
DHEA: Baseline Number Analyzed 426 participants
2071.61  (65.70)
DHEA: Week 52 Number Analyzed 426 participants
2997.25  (85.23)
DHEA: Change from Baseline Number Analyzed 426 participants
925.65  (74.35)
E2: Baseline Number Analyzed 429 participants
6.05  (1.11)
E2: Week 52 Number Analyzed 429 participants
4.46  (0.32)
E2: Change from Baseline Number Analyzed 429 participants
-1.59  (1.13)
TESTO: Baseline Number Analyzed 429 participants
161.28  (6.93)
TESTO: Week 52 Number Analyzed 429 participants
189.44  (4.79)
TESTO: Change from Baseline Number Analyzed 429 participants
28.17  (6.55)
3.Secondary Outcome
Title Change From Baseline to Week 52 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroups of the Safety Population were used for analysis. The subgroup identified "ALL" includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup "VVA" only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)).
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 476
Mean (Standard Error)
Unit of Measure: percentage of parabasal cells
Baseline: Subgroup ALL Number Analyzed 454 participants
55.49  (2.03)
Week 52: Subgroup ALL Number Analyzed 454 participants
12.81  (0.97)
Change from Baseline: Subgroup ALL Number Analyzed 454 participants
-42.67  (1.84)
Baseline: Subgroup VVA Number Analyzed 292 participants
63.95  (2.41)
Week 52: Subgroup VVA Number Analyzed 292 participants
14.80  (1.27)
Change from Baseline: Subgroup VVA Number Analyzed 292 participants
-49.14  (2.22)
4.Secondary Outcome
Title Change From Baseline to Week 52 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroups of the Safety Population were used for analysis. The subgroup identified "ALL" includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup "VVA" only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)).
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 476
Mean (Standard Error)
Unit of Measure: percentage of superficial cells
Baseline: Subgroup ALL Number Analyzed 454 participants
2.02  (0.19)
Week 52: Subgroup ALL Number Analyzed 454 participants
9.42  (0.36)
Change from Baseline: Subgroup ALL Number Analyzed 454 participants
7.41  (0.38)
Baseline: Subgroup VVA Number Analyzed 292 participants
0.96  (0.08)
Week 52: Subgroup VVA Number Analyzed 292 participants
8.81  (0.41)
Change from Baseline: Subgroup VVA Number Analyzed 292 participants
7.85  (0.42)
5.Secondary Outcome
Title Change From Baseline to Week 52 of 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroups of the Safety Population were used for analysis. The subgroup identified "ALL" includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup "VVA" only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)).
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 476
Mean (Standard Error)
Unit of Measure: pH
Baseline: Subgroup ALL Number Analyzed 457 participants
6.23  (0.04)
Week 52: Subgroup ALL Number Analyzed 457 participants
5.09  (0.04)
Change from Baseline: Subgroup ALL Number Analyzed 457 participants
-1.14  (0.04)
Baseline: Subgroup VVA Number Analyzed 293 participants
6.40  (0.04)
Week 52: Subgroup VVA Number Analyzed 293 participants
5.13  (0.05)
Change from Baseline: Subgroup VVA Number Analyzed 293 participants
-1.27  (0.05)
6.Secondary Outcome
Title Change From Baseline to Week 52 of Self-assessment of VVA 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis "MS" dyspareunia only includes subjects having MS dyspareunia (being or not most bothersome (MBS)) (n=240); the analysis "MBS/MS" only includes subjects with MS dyspareunia being MBS (n=183).
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 476
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline: Subgroup MS Number Analyzed 240 participants
2.53  (0.03)
Week 52: Subgroup MS Number Analyzed 240 participants
0.85  (0.06)
Change from Baseline: Subgroup MS Number Analyzed 240 participants
-1.68  (0.06)
Baseline: Subgroup MBS/MS Number Analyzed 183 participants
2.57  (0.04)
Week 52: Subgroup MBS/MS Number Analyzed 183 participants
0.87  (0.07)
Change from Baseline: Subgroup MBS/MS Number Analyzed 183 participants
-1.69  (0.07)
7.Secondary Outcome
Title Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness
Hide Description The severity of vaginal dryness was evaluated by a questionnaire. 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis "MS" only includes subjects having MS dryness (being or not most bothersome (MBS)) (n=251); the analysis "MBS/MS" only includes subjects with MS dryness being MBS (n=81).
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 476
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline: Subgroup MS Number Analyzed 251 participants
2.22  (0.03)
Week 52: Subgroup MS Number Analyzed 251 participants
0.59  (0.05)
Change from Baseline: Subgroup MS Number Analyzed 251 participants
-1.63  (0.05)
Baseline: Subgroup MBS/MS Number Analyzed 81 participants
2.19  (0.04)
Week 52: Subgroup MBS/MS Number Analyzed 81 participants
0.67  (0.09)
Change from Baseline: Subgroup MBS/MS Number Analyzed 81 participants
-1.52  (0.09)
8.Secondary Outcome
Title Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching
Hide Description The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching 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 52 as well as the change from Baseline to Week 52 are presented.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis "MS" only includes subjects having MS irritation/itching (being or not most bothersome (MBS)) (n=86); the analysis "MBS/MS" only includes subjects with MS irritation/itching being MBS (n=23).
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description:
DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Overall Number of Participants Analyzed 476
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline: Subgroup MS Number Analyzed 86 participants
2.10  (0.03)
Week 52: Subgroup MS Number Analyzed 86 participants
0.60  (0.08)
Change from Baseline: Subgroup MS Number Analyzed 86 participants
-1.50  (0.09)
Baseline: Subgroup MBS/MS Number Analyzed 23 participants
2.13  (0.07)
Week 52: Subgroup MBS/MS Number Analyzed 23 participants
0.74  (0.14)
Change from Baseline: Subgroup MBS/MS Number Analyzed 23 participants
-1.39  (0.16)
Time Frame From Baseline to Week 52 (+ 30-day follow-up period after last dose)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.50% DHEA
Hide Arm/Group Description DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
All-Cause Mortality
0.50% DHEA
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
0.50% DHEA
Affected / at Risk (%)
Total   18/521 (3.45%) 
Gastrointestinal disorders   
Colitis ischaemic  1  1/521 (0.19%) 
Duodenal stenosis  1  1/521 (0.19%) 
Dyspepsia  1  1/521 (0.19%) 
Pancreatitis  1  1/521 (0.19%) 
Infections and infestations   
Infectious peritonitis  1  1/521 (0.19%) 
Staphylococcal infection  1  1/521 (0.19%) 
Injury, poisoning and procedural complications   
Femur fracture  1  1/521 (0.19%) 
Laceration  1  1/521 (0.19%) 
Muscle rupture  1  1/521 (0.19%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/521 (0.19%) 
Osteoarthritis  1  2/521 (0.38%) 
Pain in extremity  1  1/521 (0.19%) 
Spinal column stenosis  1  1/521 (0.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/521 (0.19%) 
Ovarian cancer stage III  1  1/521 (0.19%) 
Psychiatric disorders   
Anxiety  1  1/521 (0.19%) 
Reproductive system and breast disorders   
Uterine prolapse  1  1/521 (0.19%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/521 (0.19%) 
Skin and subcutaneous tissue disorders   
Angioedema  1  1/521 (0.19%) 
Surgical and medical procedures   
Cystocele repair  1  1/521 (0.19%) 
Hysterectomy  1  1/521 (0.19%) 
Rectocele repair  1  1/521 (0.19%) 
Vascular disorders   
Arteriovenous fistula  1  1/521 (0.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.50% DHEA
Affected / at Risk (%)
Total   177/521 (33.97%) 
General disorders   
Application site discharge  1  73/521 (14.01%) 
Infections and infestations   
Nasopharyngitis  1  51/521 (9.79%) 
Urinary tract infection  1  53/521 (10.17%) 
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
Publications of Results:
Layout table for additonal information
Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT01256671    
Other Study ID Numbers: ERC-230
First Submitted: December 3, 2010
First Posted: December 8, 2010
Results First Submitted: March 16, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017