NCT01452373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.2 years

First QC Date

October 12, 2011

Last Update Submit

December 10, 2013

Conditions

Vasomotor SymptomsHot Flushes

Keywords

Hot flush(es)Hot flash(es)Vasomotor symptomsDehydroepiandrosterone (DHEA)PrasteroneAcolbifeneSelective estrogen receptor modulator (SERM)AntiestrogenMenopausePostmenopausal women

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • 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.

    12 weeks

  • Tolerance to systemic administration of DHEA and acolbifene.

    12 weeks

Study Arms (2)

Control (placebo)

PLACEBO COMPARATOR
Drug: Placebo

DHEA + Acolbifene

EXPERIMENTAL
Drug: DHEA and Acolbifene

Interventions

PlaceboDRUG

Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.

Control (placebo)
DHEA and AcolbifeneDRUG

DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.

Also known as: Prasterone; dehydroepiandrosterone; EM-652.HCl
DHEA + Acolbifene

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

EndoCeutics site # 06

Bathurst, New Brunswick, E2A 4X7, Canada

Location

EndoCeutics site # 70

Burlington, Ontario, L7M 4Y1, Canada

Location

EndoCeutics site # 69

Corunna, Ontario, N0N 1G0, Canada

Location

EndoCeutics site # 73

Kitchener, Ontario, N2G 1H6, Canada

Location

EndoCeutics site # 71

London, Ontario, N5Y 5K7, Canada

Location

EndoCeutics site # 72

Newmarket, Ontario, L3Y 5G8, Canada

Location

EndoCeutics site # 68

Sarnia, Ontario, N7T 4X3, Canada

Location

EndoCeutics site # 04

Drummondville, Quebec, J2B 7T1, Canada

Location

EndoCeutics site # 12

Montreal, Quebec, H4N 3C5, Canada

Location

EndoCeutics site # 02

Québec, Quebec, G1S 2L6, Canada

Location

EndoCeutics site # 01

Québec, Quebec, G1V 2L9, Canada

Location

EndoCeutics site # 18

Saint Romuald, Quebec, G6W 5M6, Canada

Location

EndoCeutics site # 08

Shawinigan, Quebec, G9N 2H6, Canada

Location

EndoCeutics site # 11

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

EndoCeutics site # 67

Victoriaville, Quebec, G6P 6P6, Canada

Location

Related Publications (5)

  • 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.

    PMID: 17643129BACKGROUND

  • 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.

    PMID: 20541662BACKGROUND

  • 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.

    PMID: 17627814BACKGROUND

  • 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.

    PMID: 14990642BACKGROUND

  • 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.

    PMID: 10418981BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Interventions

Dehydroepiandrosteroneritetronium

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Leonello Cusan, M.D., Ph.D.

    Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 14, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

CA(15)