Clinical Trial: A Clinical Trial Assessing Safety of MF101 for Hot Flushes

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

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

Current Primary Outcome: Evaluate the safety of MF101, 10 g/day and 15 g/day [ Time Frame: Randomization to 4 weeks ]

New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.


Original Primary Outcome: Same as current

Current Secondary Outcome: Compare the safety of MF101 10g/day and 15 g/day [ Time Frame: Randomization to 4 Weeks ]

To compare the safety of the 2 doses of MF101


Original Secondary Outcome: Same as current

Information By: Bionovo

Dates:
Date Received: February 16, 2011
Date Started: March 2011
Date Completion: June 2011
Last Updated: June 1, 2011
Last Verified: June 2011