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Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

Primary Purpose

Vasomotor Symptoms, Hot Flushes

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Placebo
DHEA and Acolbifene
Sponsored by
EndoCeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Symptoms focused on measuring Hot flush(es), Hot flash(es), Vasomotor symptoms, Dehydroepiandrosterone (DHEA), Prasterone, Acolbifene, Selective estrogen receptor modulator (SERM), Antiestrogen, Menopause, Postmenopausal women

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • EndoCeutics site # 06
  • EndoCeutics site # 70
  • EndoCeutics site # 69
  • EndoCeutics site # 73
  • EndoCeutics site # 71
  • EndoCeutics site # 72
  • EndoCeutics site # 68
  • EndoCeutics site # 04
  • EndoCeutics site # 12
  • EndoCeutics site # 02
  • EndoCeutics site # 01
  • EndoCeutics site # 08
  • EndoCeutics site # 11
  • EndoCeutics site # 18
  • EndoCeutics site # 67

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control (placebo)

DHEA + Acolbifene

Arm Description

Outcomes

Primary Outcome Measures

Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.

Secondary Outcome Measures

Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).
Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.
Tolerance to systemic administration of DHEA and acolbifene.

Full Information

First Posted
October 12, 2011
Last Updated
December 10, 2013
Sponsor
EndoCeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01452373
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoCeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (placebo)
Arm Type
Placebo Comparator
Arm Title
DHEA + Acolbifene
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
DHEA and Acolbifene
Other Intervention Name(s)
Prasterone; dehydroepiandrosterone; EM-652.HCl
Intervention Description
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
Primary Outcome Measure Information:
Title
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
Time Frame
12 weeks
Title
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).
Time Frame
12 weeks
Title
Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.
Time Frame
12 weeks
Title
Tolerance to systemic administration of DHEA and acolbifene.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonello Cusan, M.D., Ph.D.
Organizational Affiliation
Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
EndoCeutics site # 06
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
EndoCeutics site # 70
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
EndoCeutics site # 69
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
EndoCeutics site # 73
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1H6
Country
Canada
Facility Name
EndoCeutics site # 71
City
London
State/Province
Ontario
ZIP/Postal Code
N5Y 5K7
Country
Canada
Facility Name
EndoCeutics site # 72
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
EndoCeutics site # 68
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
EndoCeutics site # 04
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 7T1
Country
Canada
Facility Name
EndoCeutics site # 12
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
EndoCeutics site # 02
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
EndoCeutics site # 01
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 2L9
Country
Canada
Facility Name
EndoCeutics site # 08
City
Shawinigan
State/Province
Quebec
ZIP/Postal Code
G9N 2H6
Country
Canada
Facility Name
EndoCeutics site # 11
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
EndoCeutics site # 18
City
St-Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
EndoCeutics site # 67
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17643129
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.
Results Reference
background
PubMed Identifier
20541662
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.
Results Reference
background
PubMed Identifier
17627814
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.
Results Reference
background
PubMed Identifier
14990642
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.
Results Reference
background
PubMed Identifier
10418981
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.
Results Reference
background

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Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

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