This trial is active, not recruiting.

Condition hot flashes
Treatment mf101
Phase phase 1
Sponsor Bionovo
Start date March 2011
End date June 2011
Trial size 40 participants
Trial identifier NCT01300078, MF101-008


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
mf101 Menerba
MF101 10 g/day MF101 15 g/day
mf101 Menerba
MF101 10 g/day MF101 15 g/day

Primary Outcomes

Evaluate the safety of MF101, 10 g/day and 15 g/day
time frame: Randomization to 4 weeks

Secondary Outcomes

Compare the safety of MF101 10g/day and 15 g/day
time frame: Randomization to 4 Weeks

Eligibility Criteria

Female participants from 40 years up to 65 years old.

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.

Additional Information

Official title A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
Principal investigator Wulf Utian, PhD, DSc(Med), FRCOG, FACOG
Description MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Bionovo.