A Clinical Trial Assessing Safety of MF101 for Hot Flushes

A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01300078

Enrollment

Registered

2011-02-21

Start date

2011-03-31

Completion date

2011-06-30

Last updated

2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

Hot Flashes, Hot Flushes, Vasomotor Symptoms, Menopausal Symptoms

Brief summary

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.

Detailed description

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

Interventions

DRUGMF101

MF101 10 g/day MF101 15 g/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety of MF101, 10 g/day and 15 g/day	Randomization to 4 weeks	New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events.

Secondary

Measure	Time frame	Description
Compare the safety of MF101 10g/day and 15 g/day	Randomization to 4 Weeks	To compare the safety of the 2 doses of MF101

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026