A Study of MF101 in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hot Flushes, Vasomotor Symptoms

Intervention / Treatment
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* Drug: MF101 5 g/day
* Drug: Placebo
* Drug: MF101 10 g/day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks<br>|
| Experimental: MF101 5 g/day<br> | Drug: MF101 5 g/day<br>* PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks<br>|
| Experimental: MF101 10 g/day<br> | Drug: MF101 10 g/day<br>* PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo. | 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. | 12 weeks |