Vasomotor Symptoms Clinical Trial
Official title:
A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women
This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.
Menopausal women often experience debilitating menopausal vasomotor symptoms and associated
insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are
very effective; however, randomized clinical trials have shown that postmenopausal
combination hormone therapy increases the risks for stroke, cardiovascular events, and
breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms
are therefore needed.
MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a
randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety
and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal
women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe
hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5
g/day and 10 g/day) compared to placebo after 12 weeks of treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04090957 -
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT01052454 -
Mindfulness-Based Stress Reduction for Hot Flashes
|
Phase 0 | |
Completed |
NCT00535288 -
Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)
|
Phase 3 | |
Completed |
NCT01452373 -
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT00560833 -
Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
|
Phase 3 | |
Completed |
NCT05033886 -
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
|
Phase 3 | |
Completed |
NCT05083884 -
A Survey About Hot Flashes in Women Going Through the Menopause
|
||
Completed |
NCT01178892 -
MsFLASH-02: Interventions for Relief of Menopausal Symptoms: A 3-by-2 Factorial Design Examining Yoga, Exercise, and Omega-3 Supplementation
|
N/A | |
Completed |
NCT00397176 -
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
|
Phase 1 | |
Recruiting |
NCT06122181 -
Study of HS-10384 in Participants of Chinese Postmenopausal Women
|
Phase 1 | |
Not yet recruiting |
NCT06393673 -
A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal Women
|
Phase 2 | |
Withdrawn |
NCT02202707 -
Vasomotor Symptoms and Cardiovascular Control
|
N/A | |
Completed |
NCT00356447 -
Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
|
Phase 3 | |
Completed |
NCT05312567 -
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
|
Phase 2 | |
Terminated |
NCT01353963 -
Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
|
Phase 4 | |
Completed |
NCT00446199 -
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
|
Phase 3 | |
Completed |
NCT05850338 -
Determination of the Effects of Autogenic Relaxation Exercise and Cold Pillow Application on Vasomotor Symptom Control and Quality of Life in Postmenopausal Women
|
N/A | |
Completed |
NCT02803268 -
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
|
Phase 1 | |
Completed |
NCT00683800 -
Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women
|
Phase 3 | |
Completed |
NCT03512002 -
HIRREM Hot Flashes Study
|
N/A |