Clinical Trials Logo

Clinical Trial Summary

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. The study medicines (also called investigational products, or IP) are tablets of fezolinetant or placebo. An investigational product means that the product is not yet licensed. In this study, a placebo is a dummy treatment that looks like fezolinetant but does not have any medicine in it. The study will compare fezolinetant with the placebo to learn if fezolinetant reduces the number and severity of hot flashes. Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. Women will be picked for 1 of 2 treatments (fezolinetant or placebo) by chance alone. Women who take part in the study will take 2 tablets every day for 24 weeks. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study medicines (fezolinetant or placebo). The women will continue recording information about their hot flashes on the electronic device or their phone. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic several times for a check-up. This will happen during Weeks 2, 4, 8, 12, 16, 20, 24, and 27. Some women may be able to have home visits instead, from Week 2 to Week 20. At the check-up, they will be asked if they have any medical problems. Other checks will include vital signs (heart rate, temperature and blood pressure) and some blood samples taken for laboratory tests. At some check-ups, the women will have a physical exam. In Week 2 and Week 24, the women will have an ECG to check their heart rhythm. Women who have a uterus will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last check-up (at Week 27) will be 3 weeks after they take their last tablets of study medicine (fezolinetant or placebo).

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05033886
Study type Interventional
Source Astellas Pharma Inc
Contact Astellas Pharma Global Development
Phone 800-888-7704
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date October 31, 2021
Completion date May 30, 2023

See also
  Status Clinical Trial Phase
Recruiting 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
Recruiting NCT00906308 - A Study of MF101 in Postmenopausal Women 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 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
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
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 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
Recruiting NCT03512002 - HIRREM Hot Flashes Study N/A
Recruiting NCT03122301 - Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer Phase 2
Completed NCT00894543 - MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women N/A
Completed NCT00651599 - Treatment of Vasomotor Symptoms in Korean Post Menopausal Women Phase 3
Recruiting NCT02907983 - Stellate Ganglion Blockade in Post-Menopausal Women Phase 2
Completed NCT01073397 - Effect of Yoga on Objective and Subjective Menopausal Hot Flashes N/A