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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.
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF101 10 grams/day | Experimental |
| |
| MF101 15 grams/day | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF101 | Drug | MF101 10 g/day MF101 15 g/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of MF101, 10 g/day and 15 g/day | New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events. | Randomization to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the safety of MF101 10g/day and 15 g/day | To compare the safety of the 2 doses of MF101 | Randomization to 4 Weeks |
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Inclusion Criteria (partial list):
Exclusion Criteria (partial list):
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| Name | Affiliation | Role |
|---|---|---|
| Wulf Utian, PhD, DSc(Med), FRCOG, FACOG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta Bates, Jordan Research and Education Institute (REDI) | Berkeley | California | 94705 | United States | ||
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Clinical Trials Research |
| Lincoln |
| California |
| 95648 |
| United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |