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The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo vaginal ovule daily for 12 weeks |
|
| Prasterone | Experimental | Prasterone (DHEA) vaginal ovule daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Prasterone (DHEA) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear | 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. | Baseline and Week 12 |
| Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 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. | 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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Inclusion Criteria:
Main criteria:
Exclusion Criteria:
Main criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernand Labrie, M.D., Ph.D. | EndoCeutics Inc. | Study Chair |
| David F Archer, M.D. | 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 |
|---|---|---|---|
| 26291918 | Result | Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration. J Steroid Biochem Mol Biol. 2015 Nov;154:186-96. doi: 10.1016/j.jsbmb.2015.08.016. Epub 2015 Aug 17. | |
| 26597311 |
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A total of 1226 subjects were screened at 38 medical/research sites located in the US (24 centers) and Canada (14 centers) and 558 subjects were randomized. The first subject first visit was on 11-FEB-2014 and the last subject last visit was on 06-JAN-2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks |
| FG001 | 0.50% Prasterone (DHEA) | Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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 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. | 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 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. | 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 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. | 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 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. | Baseline and Week 12 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| EndoCeutics site # 21 | Sacramento | California | 95821 | United States |
| EndoCeutics site # 83 | San Diego | California | 92103 | United States |
| EndoCeutics site # 30 | San Diego | California | 92108 | United States |
| EndoCeutics site # 36 | Denver | Colorado | 80209 | United States |
| EndoCeutics site # 52 | Denver | Colorado | 80220 | United States |
| EndoCeutics site # 45 | Boynton Beach | Florida | 33472 | United States |
| EndoCeutics site # 60 | Lake Worth | Florida | 33461 | United States |
| EndoCeutics site # 54 | North Miami | Florida | 33161 | United States |
| EndoCeutics site # 80 | West Palm Beach | Florida | 33409 | United States |
| EndoCeutics site # 23 | Atlanta | Georgia | 30328 | United States |
| EndoCeutics site # 55 | Wichita | Kansas | 67226 | United States |
| EndoCeutics site # 86 | Louisville | Kentucky | 40291 | United States |
| EndoCeutics site # 27 | Lutherville | Maryland | 21093 | United States |
| EndoCeutics site # 87 | Lawrenceville | New Jersey | 08648 | United States |
| EndoCeutics site # 81 | Plainsboro | New Jersey | 08536 | United States |
| EndoCeutics site # 05 | Cleveland | Ohio | 44122 | United States |
| EndoCeutics site # 15 | Columbus | Ohio | 43213 | United States |
| EndoCeutics site # 75 | Philadelphia | Pennsylvania | 19114-1029 | United States |
| EndoCeutics site # 84 | Corpus Christi | Texas | 78414 | United States |
| EndoCeutics site # 82 | Houston | Texas | 77030 | United States |
| EndoCeutics site # 03 | Norfolk | Virginia | 23507 | United States |
| EndoCeutics site # 76 | Seattle | Washington | 98105 | United States |
| EndoCeutics site # 85 | Burlington | Ontario | L7R 4B8 | Canada |
| EndoCeutics site # 69 | Corunna | Ontario | N0N1G0 | Canada |
| EndoCeutics site # 68 | Sarnia | Ontario | N7T 4X3 | Canada |
| EndoCeutics site # 73 | Waterloo | Ontario | N2J 1C4 | Canada |
| EndoCeutics site # 04 | Drummondville | Quebec | J2B 7T1 | Canada |
| EndoCeutics site # 12 | Montreal | Quebec | H4N 3C5 | Canada |
| EndoCeutics site # 79 | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| EndoCeutics site # 02 | Québec | Quebec | G1S 2L6 | Canada |
| EndoCeutics site # 01 | Québec | Quebec | G1V 2L9 | Canada |
| EndoCeutics site # 77 | Québec | Quebec | G1W 4R4 | Canada |
| EndoCeutics site # 78 | Québec | Quebec | G3K 2P8 | Canada |
| EndoCeutics site # 18 | Saint Romuald | Quebec | G6W 5M6 | Canada |
| EndoCeutics site # 74 | Sherbrooke | Quebec | J1J 2G2 | Canada |
| EndoCeutics site # 67 | Victoriaville | Quebec | G6P 6P6 | Canada |
| Result |
| Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23. |
| 26517756 | Result | Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group. Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner. Climacteric. 2015;18(6):817-25. doi: 10.3109/13697137.2015.1077508. Epub 2015 Oct 30. |
| 26731686 | Result | Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571. |
| 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. |
| 26634942 | Result | Montesino M, Labrie F, Archer DF, Zerhouni J, Cote I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3):240-5. doi: 10.3109/09513590.2015.1110140. Epub 2016 Jan 6. |
| Safety Population |
|
| ITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks. |
| BG001 | 0.50% Prasterone (DHEA) | Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks. |
| BG002 | 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 Superficial Cells in the Maturation Index of the Vaginal Smear | 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. | 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 |
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| Primary | Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear | 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. | 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 |
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| 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 |
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| 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 |
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| 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 had self-identified moderate to severe vaginal dryness at Baseline. | Posted | Mean | Standard Error | units on a scale | Baseline and Week 12 |
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| 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 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. | 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 |
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| 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 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. | 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 |
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| 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 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. | 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 |
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| 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 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. | 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 |
|
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From Baseline to Week 12 (+ 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 ovule; daily dosing with one ovule for 12 weeks. | 0 | 180 | 10 | 180 | ||
| EG001 | 0.50% Prasterone (DHEA) | Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks | 5 | 374 | 24 | 374 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Post-procedural complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Gastric bypass | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Hernia hiatus repair | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site discharge | General disorders | MedDRA 16.1 | Systematic Assessment |
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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 |
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| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native hawaiian or Other Pacific Islander |
|
| Other |
|
| Change from Baseline to Week 12 |
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| Participants |
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