Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00906308
Study type Interventional
Source Bionovo
Contact Jesse Langon, MPH
Phone 510-4204182
Status Recruiting
Phase Phase 3
Start date October 2011

See also
  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