*Volunteers will receive all study-related care at no cost, including the study drug for up to 1 year. If you qualify, you will be compensated approximately $100 per on-site study visit, and if you take part in the full duration of the study, the compensation for your time and efforts is up to $4,000.
Both endometriosis and uterine fibroids can cause bothersome symptoms especially during menstruation.
Both conditions can make an already uncomfortable time of the month unbearable. For some women, endometriosis can cause pain even in between menstrual cycles. Endometriosis affects nearly 10% of all women, while an estimated 20-50% of women in their reproductive years have fibroids. Both conditions may have serious negative effects on many aspects of life.
The SERENE Study is evaluating a study drug to see if it successfully prevents pregnancy in women with fibroids and endometriosis.
You may qualify for the SERENE Study if you:
- Have a confirmed diagnosis of endometriosis or fibroids
- Are a woman between the ages of 18-50 years of age
- Have periods that come at about the same time every month, when you are not on birth control
- Are sexually active with a male partner who has not had a vasectomy
* All study-related care will be provided at no cost, including the study drug for up to 1 year. You also will be eligible to receive compensation for your study visits, travel, and completion of electronic diary.
Sign Up
What happens if I sign up? We will match you to a research study location in your area that needs volunteers with endometriosis or fibroids. If there isn’t a study location in your area, we will notify you when one becomes available. The study team will then contact you, and you may have the opportunity to discuss the study and participate if you qualify.
If you think you might like to participate in the SERENE Study or would like more information, please complete your information below so we can see if you may qualify. If you qualify, we will contact you about next steps.
Your participation is completely voluntary, you can choose to withdraw at any time. The information you are providing here will only be used to match you to a clinical research study in your area. Please note the information you enter will be kept private, except when ordered by law, and only accessible to our Clinical Research Partners and affiliates and applicable regulatory agencies. If you have any questions regarding the handling of the information you have provided to autocruitment.com, or if you would like to make any changes, please contact us at info@autocruitment.com.
About Endometriosis and Fibroids
Endometriosis is a condition in which tissue that normally lines the uterus grows outside of the uterus. This tissue, which does not belong outside the uterus, becomes trapped and can cycle with your period, bleed, and cause symptoms like pain during and between periods.
Endometriosis is estimated to affect between 3% and 10% of reproductive-aged women.
Fibroids are non-cancerous growths that occur in the uterus during a woman’s childbearing years. The uterine fibroids can range in size from too small to detect, to very large and uncomfortable masses.
fibroids are extremely common and are estimated to affect between 20-50% of all women at some point in their life.
Both endometriosis and uterine fibroids can share similar symptoms, including pain during and between periods.
Other symptoms include:
- Painful sex
- Painful urination
- Painful bowel movements
- Depression and fatigue
These symptoms may affect your daily life and make it hard to want to be around friends and family.
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as non-steroidal anti-inflammatories (NSAIDs), which you may have used for headaches, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the SERENE Study?
The SERENE Study is evaluating how safe and how well a study drug works to prevent pregnancy in adult women with endometriosis or fibroids.
This study is a Phase 3 study, meaning this drug has already been tested in many clinical trials. The drug being used in this study is FDA-approved to manage moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. The SERENE study is testing whether it is also effective at preventing pregnancy in women who use it for their fibroid or endometriosis symptoms.
If you qualify and choose to participate, you will have access to this study drug at no cost for up to 1-year.
What will the SERENE Study involve?
The SERENE Study will enroll about 1,020 women with endometriosis or fibroids at approximately 130 sites throughout North America. The SERENE Study is assessing an investigational treatment option that may help prevent pregnancy, while also helping to manage symptoms associated with endometriosis or fibroids.
If you qualify, you will have about 11 office visits throughout the study and 4 check-in visits will take place over the telephone approximately 6 weeks following each on-site visit during the treatment period.
During the treatment phase, you will receive the study drug for up to 1 year at no cost to you. During this time, no other form of birth control other than the study drug may be used. Following the 1-year treatment period, you are welcome to use any birth control method of your choice.
Will I receive compensation?
Volunteers who qualify to take part in the study will receive compensation for study visits, travel, and completion of electronic diary. Participants will be compensated approximately $100 per on-site study visit, and if you take part in the full duration of the study, the compensation for your time and efforts is up to $4,000.
Is there a cost to participate?
No, there is no cost to participate in the SERENE Study. If you qualify, all study-related care and study drug will be provided at no cost to you.
What else do I need to consider?
Volunteers who qualify to take part in the study will receive compensation for study visits, travel, and completion of electronic diary. Participants will be compensated approximately $100 per on-site study visit, and if you take part in the full duration of the study, the compensation for your time and efforts is up to $4,000.
How far is the study center?
We match you to a study center within a close travel distance from your home. Compensation is available for travel and for completing study visits, please speak to the study team for more details. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out, and we will delete your details. If you would like to make any changes, please contact us at info@autocruitment.com.
About the SERENE Study
The SERENE Study will enroll about 1,020 women with endometriosis or fibroids at approximately 130 sites throughout the United States. The SERENE Study is investigating a drug that is FDA-approved for management of heavy menstrual bleeding associated with uterine fibroids or moderate to severe pain associated with endometriosis for the new purpose of also preventing pregnancy in these women.
If you qualify, you will be in the study for approximately 2 years. During these 2 years, you will be required to come to the research site for about 11 office visits throughout the study and 4 check-in visits during the treatment period.
During the treatment period you will take the study drug by mouth once daily for up to 1 year. No other form of birth control is allowed during the 1 year of treatment in the study because the purpose of this study is to evaluate how well this drug prevents pregnancy when used on its own. You can use other forms of birth control during the post treatment follow-up period, if desired.
*All study-related carewill be provided at no cost, including the study drug for up to 1 year. You also will be eligible to receive compensation for your study visits, travel, and completion of a daily electronic diary. Participants will be compensated approximately $100 per on-site study visit, and if you take part in the full duration of the study, the compensation for your time and efforts is up to $4,000.
Who can take part in the SERENE Study?
You may qualify for the SERENE Study if you:
- Have a confirmed diagnosis of endometriosis or fibroids
- Are a woman between the ages of 18-50 years of age
- Have periods that come at about the same time every month, when you are not on birth control
- Are sexually active with a male partner who has not had a vasectomy
The SERENE Study is evaluating how safe and how well a study drug acts to prevent pregnancy in adult women with endometriosis or fibroids.