Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
NCT ID: NCT01452373
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
238 participants
INTERVENTIONAL
2011-10-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control (placebo)
Placebo
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
DHEA + Acolbifene
DHEA and Acolbifene
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
Interventions
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Placebo
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
DHEA and Acolbifene
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women between 40 and 75 years of age.
* Willing to participate in the study and sign an informed consent.
* Women having many moderate to severe hot flushes.
* For non-hysterectomized women, willing to have an endometrial biopsy at baseline and end of-study.
Exclusion Criteria
* Hypertension equal to or above 140/90 mm Hg.
* The administration of any investigational drug within 30 days of screening visit.
* Endometrial hyperplasia (simple or complex hyperplasia with or without atypia), cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
40 Years
75 Years
FEMALE
No
Sponsors
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EndoCeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Leonello Cusan, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
Locations
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EndoCeutics site # 06
Bathurst, New Brunswick, Canada
EndoCeutics site # 70
Burlington, Ontario, Canada
EndoCeutics site # 69
Corunna, Ontario, Canada
EndoCeutics site # 73
Kitchener, Ontario, Canada
EndoCeutics site # 71
London, Ontario, Canada
EndoCeutics site # 72
Newmarket, Ontario, Canada
EndoCeutics site # 68
Sarnia, Ontario, Canada
EndoCeutics site # 04
Drummondville, Quebec, Canada
EndoCeutics site # 12
Montreal, Quebec, Canada
EndoCeutics site # 02
Québec, Quebec, Canada
EndoCeutics site # 01
Québec, Quebec, Canada
EndoCeutics site # 18
Saint Romuald, Quebec, Canada
EndoCeutics site # 08
Shawinigan, Quebec, Canada
EndoCeutics site # 11
Sherbrooke, Quebec, Canada
EndoCeutics site # 67
Victoriaville, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ERC-207
Identifier Type: -
Identifier Source: org_study_id