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 ]
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 ]
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