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Selective Estrogen Receptor Modulator
MF101 10 grams/day for Hot Flashes
Phase 1
Waitlist Available
Led By Wulf Utian, PhD, DSc(Med), FRCOG, FACOG
Research Sponsored by Bionovo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to 4 weeks
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the safety of MF101, 10 g/day and 15 g/day
Secondary outcome measures
Compare the safety of MF101 10g/day and 15 g/day
Trial Design
2Treatment groups
Experimental Treatment
Group I: MF101 15 grams/dayExperimental Treatment1 Intervention
Group II: MF101 10 grams/dayExperimental Treatment1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BionovoLead Sponsor
7 Previous Clinical Trials
1,739 Total Patients Enrolled
2 Trials studying Hot Flashes
1,380 Patients Enrolled for Hot Flashes
Wulf Utian, PhD, DSc(Med), FRCOG, FACOGPrincipal Investigator
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