A Study of MF101 in Postmenopausal Women (HERBA)
|ClinicalTrials.gov Identifier: NCT00906308|
Recruitment Status : Unknown
Verified February 2012 by Bionovo.
Recruitment status was: Recruiting
First Posted : May 21, 2009
Last Update Posted : February 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hot Flushes Vasomotor Symptoms||Drug: MF101 5 g/day Drug: Placebo Drug: MF101 10 g/day||Phase 3|
Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.
MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||February 2013|
|Placebo Comparator: Placebo||
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
|Experimental: MF101 5 g/day||
Drug: MF101 5 g/day
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
|Experimental: MF101 10 g/day||
Drug: MF101 10 g/day
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
- Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo. [ Time Frame: 12 weeks ]Safety will be measured through clinically significant findings in physical examinations, laboratory parameters, endometrial changes, abnormal uterine bleeding and any other adverse events. Efficacy will be measured by the mean change in frequency of moderate to severe hot flushes from baseline to treatment week 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906308
|Contact: Jesse Langon, MPH||510-4204182|
|Study Director:||Mary Tagliaferri, M.D, L.Ac.||Bionovo Inc.|