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 |
|---|---|---|---|
| NCT07732452 |
Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition |
NOT_YET_RECRUITING | PHASE4 |
| NCT07729150 |
Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes |
NOT_YET_RECRUITING | NA |
| NCT07660315 |
Goji Berry and Vasomotor Symptoms Pilot Study |
NOT_YET_RECRUITING | NA |
| NCT07568236 |
A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07511660 |
Intra Ovarian Muse Cell Injection for Perimenopause Symptom Relief and Ovarian Function Restoration (MUSE-OVARY) |
ENROLLING_BY_INVITATION | |
| NCT07408115 |
Herbal Dietary Supplementation on Vasomotor Symptoms in Menopausal Women |
COMPLETED | NA |
| NCT07335224 |
Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture |
RECRUITING | NA |
| NCT07238478 |
JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women |
RECRUITING | NA |
| NCT07229404 |
A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants |
COMPLETED | PHASE1 |
| NCT07112651 |
Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause |
RECRUITING | NA |
