The PRIMROSE Study
Many women think that heavy menstrual bleeding is a normal part of their monthly cycle, but if you are experiencing menstrual bleedings that are either heavy and/or last for 5 or more days you may have Uterine Fibroids.
The PRIMROSE Study is researching if an investigational medication, taken by mouth can provide effective relief from heavy or lengthy menstrual bleeding in women who have Uterine Fibroids.
If you’ve been diagnosed with Uterine Fibroids or if you suffer from Heavy Menstrual Bleeding, or Bleeding that lasts more than 5 days, you might be eligible for the PRIMROSE Study.
Benefits of a clinical research study
Current treatments for uterine fibroids are limited in duration and long-term options are mainly surgical. By participating in a clinical research study, you will receive study-related care, study medication and sanitary protection at no cost. But most importantly, you may contribute to scientific developments that may lead to new treatment options.
With the combined efforts of researchers and clinical study participants, we hope to find better medications for future generations.
Who can take part in the PRIMROSE Study?
You may be able to take part in the PRIMROSE Study if you:
- are a woman aged 18 and older with no major health problems
- suffer or are bothered by Heavy Menstrual Bleeding or Menstrual Bleeding that lasts more than 5 days which is due to uterine fibroids
- are not planning to become pregnant in the next two years
What are Uterine Fibroids and how do I know if I have them?
Uterine fibroids are extremely common non-cancerous tumors that grow within the muscular wall of a woman’s uterus. They can vary in size and number and cause symptoms such as:
- Heavy menstrual bleeding
- Menstrual bleeding accompanied by the sensation of “gushing” or “flooding”
- Bleeding that affects work, school, or social activities
- Bleeding that lasts more than 5 days
- Abdominal pressure and pain
- Increased urinary frequency
- Reproductive dysfunction
In addition, uterine fibroids are associated with an increased risk of pregnancy complications such as infertility, miscarriage, placental abruption, and early onset of labor.
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 an investigational medication, such as: does it work? All medications must be tested in Clinical research studies before they can be approved to be prescribed to patients. Without people taking part in these studies, we would have no new medications.
What can you expect from the PRIMROSE Study
- The PRIMROSE Study will last up to 85 weeks, with up to 13 visits to a clinic in your location, plus calls as needed
- The study medication in an oral (taken by mouth) tablet or capsule which will be taken daily for up to 52 weeks
- Study related procedures will include vital signs, blood draws, bone mineral density testing, exams by a study physician and questionnaires
- You will be provided with an electronic study diary to keep track of your daily bleeding
- All study-related care is provided at no cost
How can I find out if I could participate in the study?
If you complete the online questionnaire below, you will be contacted by a qualified doctor or research nurse in your area who will explain more about the study before you make your decision about participating.
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.