A Study of MF101 in Postmenopausal Women (HERBA)

Bionovo

Status and phase: Unknown; Phase 3

Conditions: Hot Flushes; Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: MF101 10 g/day; Drug: MF101 5 g/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00906308

MF-101-004

Details and patient eligibility

About

This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.

Full description

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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (limited):

• Confirmed postmenopausal women aged 40-65
• Provide written informed consent

Exclusion Criteria (limited):

• History of malignancy, with the exception of certain types of skin cancer or cervical cancer
• Known carrier of BRCA1 or BRCA2
• Abnormal mammogram or breast examination suggestive of cancer within 9 months of screening
• Endometrial hyperplasia, polyps or abnormal uterine masses (with the exception of fibroids)
• Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents
• History of deep vein thrombosis, pulmonary embolism, severe chronic diarrhea, chronic constipation, uncontrolled inflammatory bowel syndrome or disease (IBS or IBD), or unexplained weight loss
• Active liver disease or gall bladder disease
• History of chronic hepatitis B, hepatitis C, hepatitis within 3 months, or HIV infection
• Use of prescription medications or herbal/dietary supplements for the treatment of hot flushes or those with known estrogenic/progestogenic activity within required wash-out timeframes
• Use of selective receptor modulators (SERMs), aromatase inhibitors, gonadotropin-releasing hormone agonists, selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin or clonidine within required wash-out timeframes
• Chronic use of morphine or other opiates

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

MF101 5 g/day

Experimental group

Treatment:

Drug: MF101 5 g/day

MF101 10 g/day

Experimental group

Treatment:

Drug: MF101 10 g/day