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A Study of MF101 in Postmenopausal Women

NCT00906308 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2012-02-08

No results posted yet for this study

Summary

This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.

Conditions

Interventions

DRUG

MF101 5 g/day

PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks

DRUG

Placebo

PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks

DRUG

MF101 10 g/day

PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks

Sponsors & Collaborators

  • Bionovo

    lead INDUSTRY

Principal Investigators

  • Mary Tagliaferri, M.D, L.Ac. · Bionovo Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT00906308 on ClinicalTrials.gov