A Clinical Trial Assessing Safety of MF101 for Hot Flushes

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01300078
• Other study ID #: MF101-008
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 16, 2011
• Last updated: June 1, 2011
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Bionovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• MF101
MF101 10 g/day MF101 15 g/day

Locations

Country	Name	City	State
United States	Alta Bates, Jordan Research and Education Institute (REDI)	Berkeley	California
United States	Clinical Trials Research	Lincoln	California
United States	Northern California Research	Sacramento	California
United States	Medical Center for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Bionovo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes