A Clinical Trial Assessing Safety of MF101 for Hot Flushes

Bionovo

Status and phase

Unknown

Phase 1

Conditions

Hot Flashes

Treatments

Drug: MF101

Study type

Interventional

Funder types

Industry

Identifiers

NCT01300078

MF101-008

Details and patient eligibility

About

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.

Full description

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

Enrollment

40 estimated patients

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.