What side effects are associated with this type of intervention?

Common treatments for hot flashes include nonhormonal drugs such as SSRIs and SNRIs, which can cause side effects like nausea, dizziness, and insomnia. Gabapentin may lead to drowsiness, dizziness, and peripheral edema. Clonidine can cause dry mouth, drowsiness, and constipation. Soy isoflavones are generally well-tolerated but can occasionally cause gastrointestinal issues. Nonpharmacological interventions like acupuncture and yoga have minimal side effects, primarily limited to mild discomfort or soreness at needle sites for acupuncture.

What prior FDA approvals exist?

Several FDA-approved therapies for the treatment of hot flashes in postmenopausal women include low-dose transdermal estradiol, paroxetine mesylate, and bazedoxifene/conjugated estrogens. These treatments have been shown to effectively reduce the frequency and severity of hot flashes. Additionally, megestrol acetate has demonstrated significant efficacy in reducing vasomotor symptoms in women with breast cancer. These treatments are similar to MF101, which is currently being studied for its potential to reduce moderate to severe hot flushes.

What other types of research exist?

Promising, novel alternatives to MF101 for the reduction of hot flushes in postmenopausal women include the single-capsule 17β-estradiol-progesterone (TX-001HR) and esmirtazapine. Both have shown efficacy in recent clinical trials for treating moderate-to-severe vasomotor symptoms.

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Hormone Therapy

MF101 for Hot Flashes (HERBA Trial)

Phase 3

Waitlist Available

Research Sponsored by Bionovo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed postmenopausal women aged 40-65

Be older than 18 years old

Must not have

Known carrier of BRCA1 or BRCA2

Clinical evidence of active ischemic heart disease, history of cardiovascular disease, uncontrolled hypertension, or a history of transient ischemic attacks or cerebrovascular accidents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests MF101, a plant-based treatment, on postmenopausal women aged 40-65 with moderate to severe hot flushes. It aims to reduce hot flushes using natural ingredients without hormones. The study will compare its safety and effectiveness over a few months. MF101 has been previously shown to be safe and effective in reducing hot flashes in postmenopausal women.

Who is the study for?

This trial is for postmenopausal women aged 40-65 who have moderate to severe hot flashes. Participants must not have a history of certain cancers, genetic mutations (BRCA1/2), or chronic liver and heart conditions. They should not be on medications that affect hormones or treat hot flashes within specific timeframes before the trial.

What is being tested?

The study tests MF101's safety and effectiveness in reducing hot flash frequency in postmenopausal women. It compares two doses of MF101 (5 g/day and 10 g/day) against a placebo to see which works better.

What are the potential side effects?

While the side effects are not detailed here, potential risks may include typical reactions seen with hormonal treatments such as digestive issues, changes in mood or weight, headaches, and possibly increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 40-65 and have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I carry the BRCA1 or BRCA2 gene mutation.

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I have heart disease, high blood pressure, or a history of strokes or mini-strokes.

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I have stopped taking certain hormone therapies or antidepressants as required.

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I have a history of blood clots, severe bowel issues, or unexplained weight loss.

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I have an active liver or gall bladder disease.

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I regularly use morphine or similar painkillers.

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I have a history of chronic hepatitis or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: MF101 5 g/dayExperimental Treatment1 Intervention

Group II: MF101 10 g/dayExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hot flashes include hormone therapy (HT), non-hormonal medications, and emerging treatments like MF101. Hormone therapy typically involves estrogen or a combination of estrogen and progestin, which helps stabilize fluctuating hormone levels that cause hot flashes. Non-hormonal treatments, such as neurokinin 3 receptor antagonists, work by targeting the central nervous system pathways involved in thermoregulation. MF101, a non-hormonal treatment under study, aims to reduce the frequency of hot flashes by modulating estrogen receptors without the risks associated with traditional hormone therapy. Understanding these mechanisms is crucial for patients, as it helps them and their doctors choose the most appropriate and safe treatment based on individual health profiles and preferences.

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms.Is placebo as effective as estrogen regimens on vasomotor symptoms in women with surgical menopause?Vasomotor symptoms in menopause: physiologic condition and central nervous system approaches to treatment.