Clinical trial NCT01452373: Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
Official title: DHEA + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women (Placebo Controlled, Double Blind and Randomized Phase III Study to Evaluate the Effects of 12-Week Treatment With DHEA (Prasterone) and Acolbifene on Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms
Hot Flushes
Keywords: Hot flush(es)
Hot flash(es)
Vasomotor symptoms
Dehydroepiandrosterone (DHEA)
Prasterone
Acolbifene
Selective estrogen receptor modulator (SERM)
Antiestrogen
Menopause
Postmenopausal women
Lead sponsor: EndoCeutics Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 238
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Main Inclusion Criteria:

* Postmenopausal women (non-hysterectomized or hysterectomized).
* 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.

Main Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* 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.

Primary outcomes:
measure: Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
timeFrame: 12 weeks
measure: Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).
timeFrame: 12 weeks
measure: Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.
timeFrame: 12 weeks
measure: Tolerance to systemic administration of DHEA and acolbifene.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bathurst
country: Canada
facility: EndoCeutics site # 06
state: New Brunswick
city: Burlington
country: Canada
facility: EndoCeutics site # 70
state: Ontario
city: Corunna
country: Canada
facility: EndoCeutics site # 69
state: Ontario
city: Kitchener
country: Canada
facility: EndoCeutics site # 73
state: Ontario
city: London
country: Canada
facility: EndoCeutics site # 71
state: Ontario
city: Newmarket
country: Canada
facility: EndoCeutics site # 72
state: Ontario
city: Sarnia
country: Canada
facility: EndoCeutics site # 68
state: Ontario
city: Drummondville
country: Canada
facility: EndoCeutics site # 04
state: Quebec
city: Montreal
country: Canada
facility: EndoCeutics site # 12
state: Quebec
city: Quebec City
country: Canada
facility: EndoCeutics site # 02
state: Quebec
city: Quebec City
country: Canada
facility: EndoCeutics site # 01
state: Quebec
city: Shawinigan
country: Canada
facility: EndoCeutics site # 08
state: Quebec
city: Sherbrooke
country: Canada
facility: EndoCeutics site # 11
state: Quebec
city: St-Romuald
country: Canada
facility: EndoCeutics site # 18
state: Quebec
city: Victoriaville
country: Canada
facility: EndoCeutics site # 67
state: Quebec
Study officials:
affiliation: Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
name: Leonello Cusan, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.