Hot Flashes - Postmenopausal Women - Valley Village CA

Summary:

This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman’s last period. Hot flashes can interrupt a woman’s daily life.

The purpose of this study, SKYLIGHT, is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the “adverse events.” Those are the side effects that study participants have while they are in the study. 

The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.)

Women in the SKYLIGHT study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks. The duration of the entire study is about 14 months. 17-18 clinic visits throughout the entire study. 

This study is “double-blinded.” That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo). There will be about 1500 women in the United States will participate in this study. 

 

To qualify for SKYLIGHT, Hot Flash study, you must be:

1. Women between the ages of 40 to 65
2. Suffer from several hot flashes a day
3. Postmenopausal
4. BMI between 18-38
5. NOT on any hormonal or herbal supplements for hot flashes

Qualified Participants May Receive:

Patient who qualify to participate the SKYLIGHT study will receive the following services during the study visits:

1. Bone Density Scan (if applicable)
2. Mammogram exam if no prior mammogram completed within 9 months
3. Transvaginal Ultrasound
4. Endometrial Biopsy
5. Pap smear if no prior pap smear completed within 9 months. 
6. Physical Exam
7. Blood/ Lab Result
8. Urine Result
9. ECG report
10. eDiary to record hot flashes on a daily basis
11. Study Medication to hopefully alleviate hot flashes symptoms
12. $75 per completed study visits, up to 18 visits.