NCT01452373 is a Phase 3 clinical trial of DHEA and Acolbifene in Vasomotor Symptoms, sponsored by EndoCeutics Inc..

Who is sponsoring NCT01452373?

NCT01452373 is sponsored by EndoCeutics Inc..

What drugs are being tested in NCT01452373?

Interventions in NCT01452373: Placebo, DHEA and Acolbifene.

What condition does NCT01452373 study?

NCT01452373 studies Vasomotor Symptoms, Hot Flushes.

Is NCT01452373 still recruiting?

NCT01452373 is currently completed. Last updated 10 December 2013.

Last reviewed 2013-12-10 · How we verify

NCT01452373

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 3 Last updated 10 December 2013

What this trial tests

Phase 3 trial testing Placebo in Vasomotor Symptoms in 238 participants. Completed in 1 May 2013.

Timeline

1 October 2011

Primary endpoint
1 December 2012

1 May 2013

Quick facts

Lead sponsor	EndoCeutics Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	238
Start date	1 October 2011
Primary completion	1 December 2012
Estimated completion	1 May 2013
Sites	15 locations across Canada

Drugs / interventions tested

Placebo
DHEA and Acolbifene — full drug profile →

Conditions studied

Vasomotor Symptoms — all drugs for Vasomotor Symptoms →
Hot Flushes — all drugs for Hot Flushes →

Sponsor

EndoCeutics Inc. — full company profile →

Who can join

Adults 40 to 75, female only, with Vasomotor Symptoms or Hot Flushes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Vasomotor Symptoms

Currently open trials in the same condition.

NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
NCT07112651 — Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause · NA · recruiting
NCT07042516 — Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS). · Phase 2 · recruiting
NCT06628388 — Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong · NA · recruiting

Other EndoCeutics Inc. trials

Trials by the same sponsor.

NCT03619005 — Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study · Phase 3 · withdrawn
NCT03740945 — Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Can · Phase 3 · withdrawn
NCT03287232 — Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01452373 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EndoCeutics Inc.
Last refreshed: 10 December 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01452373.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing