The FDA removed black box warnings related to breast cancer, cardiovascular disease and dementia from six hormone replacement therapies for menopausal women, following a comprehensive review of scientific literature.
The FDA has approved labeling changes to six menopausal hormone therapy products, removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia that had been in place since 2003.
Vistagen reported fiscal Q3 2026 results with $61.8 million in cash as of December 31, 2025, while advancing its PALISADE-4 Phase 3 trial of fasedienol for social anxiety disorder and preparing an IND submission for refisolone in menopause symptoms.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07602530 |
A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice |
RECRUITING | |
| NCT07535541 |
A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (Prostate 007) |
RECRUITING | NA |
| NCT07533097 |
The Effect of Cold Packs on Hot Flushes and Depression in Women Going Through the Climacteric Period |
NOT_YET_RECRUITING | NA |
| NCT07455812 |
A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause |
ACTIVE_NOT_RECRUITING | |
| NCT07422727 |
Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Therapy |
ENROLLING_BY_INVITATION | NA |
| NCT07419542 |
Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes |
NOT_YET_RECRUITING | NA |
| NCT07408115 |
Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women |
COMPLETED | NA |
| NCT07402096 |
Effect of a Mindfulness-Based Stress Reduction Program on Hot Flashes and Sleep Quality in Menopausal Women: A Randomized Controlled Trial |
NOT_YET_RECRUITING | NA |
| NCT07335224 |
Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture |
RECRUITING | NA |
| NCT07294339 |
A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer |
NOT_YET_RECRUITING | NA |
