The ASPIRE-1 Study is for an investigational medicine, taken by mouth, to see if it can help reduce the frequency and severity of hot flashes (feeling flushed and/or sweaty) associated with menopause.
Many people think that hot flashes are a normal part of aging, but sometimes these symptoms can get in the way of daily activities and sleep.
About 360 women in 50 locations across the United States will take part in this study.
Participants will receive all study medication and study-related care from a specialist physician at no cost. The study will involve 1 - 2 visits a month to a study center in your area.
What are hot flashes?
A hot flash is a sudden sensation of heat or warmth that begins in the head and neck regions and can spread over the body, lasting from 30 seconds to a few minutes. They may be accompanied by redness of the skin, known as flushing, and excessive sweating.
Hot flashes are a characteristic symptom of menopause or postmenopause. They are thought to be caused by the complex hormonal changes that accompany the menopause transition. Hot flashes can occur 5+ years after menopause.
About 70% of women experience hot flashes at some point during menopause.
For many women hot flashes are most troubling at night when excess sweating can make it difficult to sleep.
What is a Clinical research study?
A clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about a potential new medication, such as: Does it work? All medications must be tested in clinical research studies before they can be prescribed to patients. Without people taking part in these studies, we would have no new medications.
What happens if I sign up?
We will match you or your family member to a clinical research study in your area that is seeking women who suffer from hot flashes (feeling flushed and/or sweaty) associated with menopause, or notify you when one becomes available. The study center will contact you to explain more about the study before you make your decision about participating. You may attend an in-person screening visit where a specialist physician will help determine if the study is right for you.
Frequently Asked Questions
You may be able to take part in the ASPIRE-1 Study if you:
- are a woman who has gone through menopause (stopped having periods)
- are bothered by hot flashes that include sweating about 7 times per day
- are not taking antidepressants or medicines that contain estrogen
The investigational medicine is thought to work by affecting how your body senses when something is cold. Researchers think this might help with hot flashes.
The ASPIRE-1 Study will include 7 study visits and at least 1 phone call over a period of about 20 weeks.
Compensation is available. Please discuss this with the study team when they contact you.
No, all study-related medical care, study medications, and study examinations will be provided to you at no cost.
The study center will be able to explain more about what the ASPIRE-1 Study will involve and it is up to you to decide if you want to take part. And remember – participation is entirely voluntary. Even if you decide to take part, it’s absolutely fine if you change your mind later. You will be able to leave the study at any time if you wish.