A Clinical Trial Assessing Safety of MF101 for Hot Flushes

A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.

Study Overview

• Status: Unknown
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: MF101

Detailed Description

MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94705
      • Alta Bates, Jordan Research and Education Institute (REDI)
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Sacramento, California, United States, 95821
      • Northern California Research
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria (partial list):

• Postmenopausal women aged 40-65 years.
• Provide informed consent.
• Currently receive medical care from a health care provider. Other inclusions apply.

Exclusion Criteria (partial list):

• History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening.
• Unexplained uterine bleeding within 6 months prior to Screening.
• History of deep vein thrombosis or pulmonary embolism.
• Active liver disease or a history of impaired.
• Active gallbladder disease. Other exclusions apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MF101 10 grams/day	Drug: MF101; MF101 10 g/day MF101 15 g/day; Other Names: Menerba
EXPERIMENTAL: MF101 15 grams/day	Drug: MF101; MF101 10 g/day MF101 15 g/day; Other Names: Menerba

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety of MF101, 10 g/day and 15 g/day	New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.	Randomization to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the safety of MF101 10g/day and 15 g/day	To compare the safety of the 2 doses of MF101	Randomization to 4 Weeks

Collaborators and Investigators

• Sponsor: Bionovo
• Investigators: Principal Investigator: Wulf Utian, PhD, DSc(Med), FRCOG, FACOG

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ANTICIPATED): June 1, 2011
• Study Completion (ANTICIPATED): June 1, 2011

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (ESTIMATE): February 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2011
• Last Update Submitted That Met QC Criteria: June 1, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Vasomotor Symptoms; Hot Flashes; Menopausal Symptoms; Hot Flushes
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: MF101-008