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The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 0.25% DHEA | Experimental |
| |
| 0.5% DHEA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo vaginal suppository |
| |
| DHEA |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Vaginal pH | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Severity of Vaginal Dryness | 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. | Baseline and Week 12 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David F Archer, MD | Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EndoCeutics site # 39 | Montgomery | Alabama | 36117 | United States | ||
| EndoCeutics site # 14 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25734980 | Result | Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428. | |
| 25968836 | Result |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo vaginal suppository |
| FG001 | 0.25% DHEA | DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. |
|
|
| DHEA | Drug | Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. |
|
|
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | 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. | Baseline and Week 12 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| EndoCeutics site # 21 | Sacramento | California | 95821 | United States |
| EndoCeutics site # 30 | San Diego | California | 92108 | United States |
| EndoCeutics site # 17 | San Diego | California | 92120 | United States |
| EndoCeutics site # 36 | Denver | Colorado | 80218 | United States |
| EndoCeutics site # 42 | Milford | Connecticut | 06460 | United States |
| EndoCeutics site # 45 | Boynton Beach | Florida | 33472 | United States |
| EndoCeutics site # 26 | Jacksonville | Florida | 32207 | United States |
| EndoCeutics site # 23 | Sandy Springs | Georgia | 30328 | United States |
| EndoCeutics site # 10 | Meridian | Idaho | 83642 | United States |
| EndoCeutics site # 27 | Baltimore | Maryland | 21285-6815 | United States |
| EndoCeutics site # 22 | Kalamazoo | Michigan | 49009 | United States |
| EndoCeutics site # 25 | Lincoln | Nebraska | 68510 | United States |
| EndoCeutics site # 28 | Moorestown | New Jersey | 08057 | United States |
| EndoCeutics site # 44 | New Brunswick | New Jersey | 08901 | United States |
| EndoCeutics site # 19 | New York | New York | 10016 | United States |
| EndoCeutics site # 16 | Durham | North Carolina | 27713 | United States |
| EndoCeutics site # 05 | Cleveland | Ohio | 44122 | United States |
| EndoCeutics site # 15 | Columbus | Ohio | 43213 | United States |
| EndoCeutics site # 35 | Pittsburgh | Pennsylvania | 15206 | United States |
| EndoCeutics site # 09 | West Jordan | Utah | 84088 | United States |
| EndoCeutics site # 31 | Charlottesville | Virginia | 22903 | United States |
| EndoCeutics site # 03 | Norfolk | Virginia | 23507 | United States |
| EndoCeutics site # 13 | Calgary | Alberta | T2N 4L7 | Canada |
| EndoCeutics site # 06 | Bathurst | New Brunswick | E2A 4X7 | Canada |
| EndoCeutics site # 04 | Drummondville | Quebec | J2B 7T1 | Canada |
| EndoCeutics site # 12 | Montreal | Quebec | H4N 3C5 | Canada |
| EndoCeutics site # 02 | Québec | Quebec | G1S 2L6 | Canada |
| EndoCeutics site # 01 | Québec | Quebec | G1V 2L9 | Canada |
| EndoCeutics site # 18 | Saint Romuald | Quebec | G6W 5M6 | Canada |
| EndoCeutics site # 08 | Shawinigan | Quebec | G9N 2H6 | Canada |
| EndoCeutics site # 11 | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470. |
| 26972555 | Result | Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10. |
| FG002 | 0.50% DHEA | DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. |
| Safety Population |
|
| ITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo vaginal suppository |
| BG001 | 0.25% DHEA | DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. |
| BG002 | 0.50% DHEA | DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 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. | 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. | Posted | Mean | Standard Error | Percentage of parabasal cells | Baseline and Week 12 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | 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. | 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. | Posted | Mean | Standard Error | Percentage of superficial cells | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Week 12 in Vaginal pH | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Dryness | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
From Baseline up to 12 Weeks (+ 30-day follow-up period after last dose)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo vaginal suppository | 0 | 80 | 9 | 80 | ||
| EG001 | 0.25% DHEA | DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. | 3 | 86 | 12 | 86 | ||
| EG002 | 0.50% DHEA | DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks. | 1 | 87 | 10 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site discharge | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Data Analysis | Endoceutics | 418-653-0033 | 215 | celine.martel@endoceutics.com |
| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
Not provided
Not provided
| Black or African American |
|
| Asian |
|
| Other |
|
|
| Change from Baseline to Week 12 |
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