About the Study
WHAT ARE HOT FLASHES?
Hot flashes are a common symptom that women experience while going through menopause. Women who experience hot flashes may have:
- a sudden feeling of warmth, especially through the face, neck, and chest
- a flushed appearance
- increased heart rate
- sweating, primarily on the upper body (Hot flashes are not related to the temperature of a room or how much clothing you are wearing and may be so intense that sweat soaks through nightclothes and bed sheets.)
WHAT IS THE OASIS STUDY?
The OASIS study is composed of three research studies investigating the safety and effectiveness of an investigational medication called elinzanetant to see if it may help reduce hot flashes associated with menopause. Elinzanetant is non-hormonal and is taken orally in the form of a capsule.
Once enrolled in the study, you will be randomly placed in one of two groups; one group gets the study medication, the other group receives a placebo which contains no active ingredients. If you are part of the study group being administered a placebo and depending on the study in which you are enrolled, you may be administered the active study drug at nearly the halfway point of your participation. Overall, the number of participants receiving the study drug compared to those receiving placebo is about a 2 to 1 ratio. Neither study participants, nor study doctors will know which participants are receiving the study drug versus the placebo.
WHAT HAPPENS DURING THE STUDY?
The study will include 3 phases; Screening, Treatment, and Follow-Up. During Screening, your study doctor and their staff will collect information about your condition and tests will be performed to help make sure it is safe for you to participate in the study. The Treatment phase of your participation includes taking the study medication orally, once daily (active or placebo). You will attend scheduled visits which may include physical examinations, blood draws, and questionnaires to fill out. You will also be given a handheld device on which you will make daily entries into an electronic diary. When you have finished the Treatment phase, and after you are finished taking the study medication, there will be a Follow-Up visit.
HOW LONG CAN I EXPECT TO BE IN THE STUDY?
Depending on which of the three studies you are enrolled in, your participation will last for a maximum of 9 to 15 months. It will include up to 11 visits to the study doctor’s clinic and one or two phone calls. Your participation in the study is completely voluntary and you may withdraw at any time for any reason.
WHAT ARE THE ELIGIBILITY REQUIREMENTS?
Among several other criteria, here are a few of the requirements for eligibility:
- You must be a female, aged 40 to 65.
- You have not had a menstrual period for at least 6 months.
- You are experiencing hot flashes associated with menopause.
- You are in generally good health with no history of malignancy, clinically significant heart problems, hypertension, or hyperthyroidism.
WHAT ARE THE BENEFITS TO BEING IN THE STUDY?
If you qualify for the OASIS study and decide to participate:
- All study-related medications, care, and examinations administered by medical doctors and clinicians are provided at no cost to you.
- You will gain valuable information about menopause and how to manage your symptoms.
- You may be compensated for your time and travel.
- You will be helping study doctors learn more about menopausal medications including their safety and effectiveness. This is a step toward possible future development of a medication that may bring relief to millions of women who experience menopausal hot flashes.
I AM INTERESTED. WHAT DO I DO NOW?
Click here to answer a few short questions to see if you may qualify to begin the screening process at a study site. If your answers match OASIS study requirements, you will be directed to select a study site from a provided list of sites near you.