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The purpose of this Phase III trial is to evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (placebo) | Placebo Comparator |
| |
| DHEA + Acolbifene | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes. | 12 weeks | |
| Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms). | 12 weeks | |
| Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonello Cusan, M.D., Ph.D. | Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EndoCeutics site # 06 | Bathurst | New Brunswick | E2A 4X7 | Canada | ||
| EndoCeutics site # 70 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17643129 | Background | Labrie F. Drug insight: breast cancer prevention and tissue-targeted hormone replacement therapy. Nat Clin Pract Endocrinol Metab. 2007 Aug;3(8):584-93. doi: 10.1038/ncpendmet0559. | |
| 20541662 | Background | Labrie F. DHEA, important source of sex steroids in men and even more in women. Prog Brain Res. 2010;182:97-148. doi: 10.1016/S0079-6123(10)82004-7. |
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| DHEA and Acolbifene | Drug | DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks. |
|
|
| 12 weeks |
| Tolerance to systemic administration of DHEA and acolbifene. | 12 weeks |
| Burlington |
| Ontario |
| L7M 4Y1 |
| Canada |
| EndoCeutics site # 69 | Corunna | Ontario | N0N 1G0 | Canada |
| EndoCeutics site # 73 | Kitchener | Ontario | N2G 1H6 | Canada |
| EndoCeutics site # 71 | London | Ontario | N5Y 5K7 | Canada |
| EndoCeutics site # 72 | Newmarket | Ontario | L3Y 5G8 | Canada |
| EndoCeutics site # 68 | Sarnia | Ontario | N7T 4X3 | 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 |
| EndoCeutics site # 67 | Victoriaville | Quebec | G6P 6P6 | Canada |
| 17627814 | Background | Labrie F, Belanger A, Labrie C, Candas B, Cusan L, Gomez JL. Bioavailability and metabolism of oral and percutaneous dehydroepiandrosterone in postmenopausal women. J Steroid Biochem Mol Biol. 2007 Oct;107(1-2):57-69. doi: 10.1016/j.jsbmb.2007.02.007. Epub 2007 Jun 8. |
| 14990642 | Background | Labrie F, Champagne P, Labrie C, Roy J, Laverdiere J, Provencher L, Potvin M, Drolet Y, Pollak M, Panasci L, L'Esperance B, Dufresne J, Latreille J, Robert J, Samson B, Jolivet J, Yelle L, Cusan L, Diamond P, Candas B. Activity and safety of the antiestrogen EM-800, the orally active precursor of acolbifene, in tamoxifen-resistant breast cancer. J Clin Oncol. 2004 Mar 1;22(5):864-71. doi: 10.1200/JCO.2004.05.122. |
| 10418981 | Background | Labrie F, Labrie C, Belanger A, Simard J, Gauthier S, Luu-The V, Merand Y, Giguere V, Candas B, Luo S, Martel C, Singh SM, Fournier M, Coquet A, Richard V, Charbonneau R, Charpenet G, Tremblay A, Tremblay G, Cusan L, Veilleux R. EM-652 (SCH 57068), a third generation SERM acting as pure antiestrogen in the mammary gland and endometrium. J Steroid Biochem Mol Biol. 1999 Apr-Jun;69(1-6):51-84. doi: 10.1016/s0960-0760(99)00065-5. |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| C012121 | ritetronium |
| 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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