drugset / Trial / NCT05664477
PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition
Phase 2
Active not recruiting
100 enrolled
Roberta Brinton
ADM Diagnostics · collabCornell University · collabNational Institute on Aging (NIA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a proof-of-concept phase 2 clinical trial to investigate the safety and effect of the phytoestrogenic supplement PhytoSERM on regional brain metabolism by fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in peri- and postmenopausal women. The investigators hypothesize that there will be a significant difference between the PhytoSERM group and placebo group in glucose brain metabolism.
Timeline
- Start
- 2024-01-10
- Primary completion
- 2027-01-31
- Completion
- 2027-01-31
Publications
- Background Hernandez G, Zhao L, Franke AA, Chen YL, Mack WJ, Brinton RD, Schneider LS. Pharmacokinetics and safety profile of single-dose administration of an estrogen receptor beta-selective phytoestrogenic (phytoSERM) formulation in perimenopausal and postmenopausal women. Menopause. 2018 Feb;25(2):191-196. doi: 10.1097/GME.0000000000000984.
- Background Schneider LS, Hernandez G, Zhao L, Franke AA, Chen YL, Pawluczyk S, Mack WJ, Brinton RD. Safety and feasibility of estrogen receptor-beta targeted phytoSERM formulation for menopausal symptoms: phase 1b/2a randomized clinical trial. Menopause. 2019 Aug;26(8):874-884. doi: 10.1097/GME.0000000000001325.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PhytoSERM | Other / unclassified | 50 mg | Oral |