A Clinical Trial Assessing Safety of MF101 for Hot Flushes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MF101 10 grams/day

Group Type EXPERIMENTAL

MF101

Intervention Type DRUG

MF101 10 g/day MF101 15 g/day

MF101 15 grams/day

Group Type EXPERIMENTAL

MF101

Intervention Type DRUG

MF101 10 g/day MF101 15 g/day

Interventions

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MF101

MF101 10 g/day MF101 15 g/day

Intervention Type DRUG

Other Intervention Names

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Menerba

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women aged 40-65 years.
* Provide informed consent.
* Currently receive medical care from a health care provider. Other inclusions apply.

Exclusion Criteria

* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes