Vasomotor SymptomsPhase 3NCT01452373
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
A Phase 3 study testing DHEA and Acolbifene in people with Vasomotor Symptoms and Hot Flushes, run by EndoCeutics Inc. at 15 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Vasomotor Symptoms, Hot Flushes
- What is being tested?
- DHEA and Acolbifene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 15 sitesCanada
- Study dates
- Oct 2011to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
EndoCeutics site # 06
Bathurst, New Brunswick, E2A 4X7
EndoCeutics site # 70
Burlington, Ontario, L7M 4Y1
EndoCeutics site # 69
Corunna, Ontario, N0N 1G0
EndoCeutics site # 04
Drummondville, Quebec, J2B 7T1
EndoCeutics site # 73
Kitchener, Ontario, N2G 1H6
EndoCeutics site # 71
London, Ontario, N5Y 5K7
EndoCeutics site # 12
Montreal, Quebec, H4N 3C5
EndoCeutics site # 72
Newmarket, Ontario, L3Y 5G8
EndoCeutics site # 02
Québec, Quebec, G1S 2L6
EndoCeutics site # 01
Québec, Quebec, G1V 2L9
EndoCeutics site # 18
Saint Romuald, Quebec, G6W 5M6
EndoCeutics site # 68
Sarnia, Ontario, N7T 4X3
EndoCeutics site # 08
Shawinigan, Quebec, G9N 2H6
EndoCeutics site # 11
Sherbrooke, Quebec, J1H 1Z1
EndoCeutics site # 67
Victoriaville, Quebec, G6P 6P6
About this study
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)
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.
- Conditions
- Vasomotor Symptoms, Hot Flushes
- Being tested
- Placebo, DHEA and Acolbifene
- Keywords
- Hot flush(es), Hot flash(es), Vasomotor symptoms, Dehydroepiandrosterone (DHEA), Prasterone, Acolbifene, Selective estrogen receptor modulator (SERM), Antiestrogen, Menopause, Postmenopausal women
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
DHEA and AcolbifeneDrug
Also called Prasterone; dehydroepiandrosterone; EM-652.HCl
DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control (placebo) | Placebo comparator | Not described Receives: Drug: Placebo |
| DHEA + Acolbifene | Experimental | Not described Receives: Drug: DHEA and Acolbifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
Measured: 12 weeks
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.
Measured: 12 weeks
Secondary outcomes (3)
Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).
Measured: 12 weeks
Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.
Measured: 12 weeks
Tolerance to systemic administration of DHEA and acolbifene.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoCeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonello Cusan, M.D., Ph.D., Principal investigator, Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452373
- Sponsor's protocol ID
- ERC-207
- Status last verified
- Dec 2013
- First submitted
- 12 Oct 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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 17643129Labrie 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 20541662Labrie 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 17627814Labrie 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 14990642Labrie 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01452373
- Acronym / sponsor ID
- ERC-207
- Conditions
- Vasomotor Symptoms, Hot Flushes
- Keywords
- Hot flush(es), Hot flash(es), Vasomotor symptoms, Dehydroepiandrosterone (DHEA), Prasterone, Acolbifene, Selective estrogen receptor modulator (SERM), Antiestrogen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- EndoCeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (placebo) | Placebo comparator | Drug: Placebo |
| DHEA + Acolbifene | Experimental | Drug: DHEA and Acolbifene |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks. | Drug | Control (placebo) |
| DHEA and AcolbifeneAlso: Prasterone; dehydroepiandrosterone; EM-652.HClDHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks. | Drug | DHEA + Acolbifene |
Primary outcome
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes.
Time frame: 12 weeks
Co-primary endpoint: change from baseline to week 12 in severity of moderate to severe hot flushes.
Time frame: 12 weeks
3 secondary outcomes
Change from baseline to week 12 on vaginal atrophy parameters (superficial cells, parabasal cells, pH, vaginal atrophy symptoms).
Time frame: 12 weeks
Change from baseline to week 12 on sexual function and quality of life as evaluated by appropriate questionnaires.
Time frame: 12 weeks
Tolerance to systemic administration of DHEA and acolbifene.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 17643129Labrie 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.
- Background: PubMed 20541662Labrie 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.
- Background: PubMed 17627814Labrie 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.
- Background: PubMed 14990642Labrie 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.
- Background: PubMed 10418981Labrie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonello Cusan, M.D., Ph.D. principal investigator
Clinique de Recherche en Traitements Hormonaux, 2785 blvd Laurier - Suite SS5, Quebec, QC, Canada
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DHEA and Acolbifene in people with Vasomotor Symptoms and Hot Flushes, run by EndoCeutics Inc. at 15 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary endpoint: change from baseline to week 12 in frequency of moderate to severe hot flushes. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452373, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.