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

NCT01452373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2013-12-11

No results posted yet for this 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.

Conditions

Interventions

DRUG

Placebo

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

DRUG

DHEA and Acolbifene

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

Sponsors & Collaborators

  • EndoCeutics Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31
Completion
2013-05-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452373 on ClinicalTrials.gov