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CompletedNCT01452373Updated Dec 11, 2013

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

A Phase 3 interventional study of Placebo and DHEA and Acolbifene in Vasomotor Symptoms and Hot Flushes, sponsored by EndoCeutics Inc.. Completed at 15 sites in Canada. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-11.

Sponsored by EndoCeutics Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
Female
01

Study 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.

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Conditions studied

  • 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
03

In context

Flushing

60 studies on the registry are indexed under Flushing; 7 are open to participants now.

This study's enrollment of 238 is above the median of 100 across 52 interventional studies indexed under Flushing.

Browse Flushing studies →

Lead sponsor

EndoCeutics Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Female
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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
238 participants (actual)

Study arms

  • Placebo comparator
    Control (placebo)

    Drug: Placebo

  • Experimental
    DHEA + Acolbifene

    Drug: DHEA and Acolbifene

Interventions

  • DrugPlacebo

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

  • DrugDHEA and Acolbifene

    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

06

What researchers measure

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).

    Time frame: 12 weeks

  2. Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.

    Time frame: 12 weeks

  3. Tolerance to systemic administration of DHEA and acolbifene.

    Time frame: 12 weeks

07

Study locations

15 sites
  • EndoCeutics site # 06
    Bathurst, New Brunswick E2A 4X7, Canada
  • EndoCeutics site # 70
    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
    Quebec City, Quebec G1S 2L6, Canada
  • EndoCeutics site # 01
    Quebec City, Quebec G1V 2L9, Canada
  • EndoCeutics site # 08
    Shawinigan, Quebec G9N 2H6, Canada
  • EndoCeutics site # 11
    Sherbrooke, Quebec J1H 1Z1, Canada
  • EndoCeutics site # 18
    St-Romuald, Quebec G6W 5M6, Canada
  • EndoCeutics site # 67
    Victoriaville, Quebec G6P 6P6, Canada
08

References and documents

Publications

  • 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. PubMed 17643129 ↗
  • 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. PubMed 20541662 ↗
  • 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. PubMed 17627814 ↗
  • 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. PubMed 14990642 ↗
  • 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. PubMed 10418981 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01452373
Lead sponsor
EndoCeutics Inc.
Responsible party
Sponsor
First posted
Oct 14, 2011
Start date
Oct 2011
Primary completion
Dec 2012
Completion
May 2013
Last update
Dec 11, 2013

Study contacts

Leonello Cusan, M.D., Ph.D.
principal investigator · Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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