Do You Have
Endometriosis or Uterine Fibroids?

Explore an oral contraceptive clinical study.
Now enrolling: The SERENE study for women 18 to 50 years of age.

  • The SERENE study is evaluating an investigational drug that can prevent pregnancy in adult women with uterine fibroids or endometriosis.
  • The study presents an opportunity for doctors to learn more about the safety and effectiveness of the drug, as well as determine its efficacy in preventing pregnancy.
  • Pharmaceutical companies use clinical research studies like this one to learn more about investigational drugs before they are made available to the public.
  • This medication is developed by MYOVANT Sciences. South Florida Clinical Research Institute was selected by MYOVANT Sciences to conduct clinical research for SERENE in South Florida.

The SERENE oral contraceptive research study is looking to prevent pregnancy in adult women with uterine fibroids or endometriosis.

 

This study provides doctors greater insight into an investigational drug that prevents pregnancy in women with uterine fibroids and endometriosis. Uterine fibroids are noncancerous growths of the uterus. Endometriosis occurs when tissue similar to the uterus lining grows on the walls of the abdominal and pelvic cavities, ovaries, bowel, and other organs in the pelvis.

 

The results from this study will help women and their doctors make informed decisions about contraception (birth control) methods.

Volunteers who qualify to take part in the study may receive compensation for time and travel.

This clinical study will research the safety and effectiveness of an investigational birth control pill to prevent pregnancy in adult women with uterine fibroids or endometriosis.

To be eligible for this study, at a minimum you must:

  • Be a premenopausal woman 18 to 50 years of age and have normal, regular menstrual cycles that are between 21 and 35 days
  • Be sexually active and have requested contraception from your doctor to avoid pregnancy
  • Have a diagnosis of either uterine fibroids with heavy menstrual bleeding or endometriosis with associated moderate to severe pain
  • Be willing to use an investigational product as the sole method of contraception for one year (for example: condoms, diaphragms, and withdrawal are not allowed)
  • Agree to complete a daily electronic diary (eDiary)

In this study, you will take the investigational drug by mouth once daily for up to one year. No other form of contraception (condoms, pills, patches, or rings) is allowed during your participation in the study. You’ll also complete an eDiary questionnaire daily and take a home pregnancy test every 28 days. The study site staff will provide training on completing the eDiary correctly. They will also explain how to take the study medication and the home pregnancy test. This study requires two years of your participation.

About the SERENE Study of Relugolix Contraception Method

This study provides doctors greater insight into an investigational drug that prevents pregnancy in women with uterine fibroids and endometriosis. Uterine fibroids are noncancerous growths of the uterus. Endometriosis occurs when tissue similar to the uterus lining grows on the walls of the abdominal and pelvic cavities, ovaries, bowel, and other organs in the pelvis. The results from this study will help women and their doctors make informed decisions about contraception (birth control) methods.

 

In this study, you will take the investigational drug by mouth once daily for up to one year. Throughout the two years you are monitored, you’ll have both a treatment and a post-treatment follow-up period, requiring you to visit the study center at least ten times. During the treatment period, you will take the investigational drug daily for up to one year and have on-site visits and safety follow-up care by phone. The post-treatment follow-up period will monitor your bone mineral density, which consists of three on-site visits over one year.

Who is eligible to participate in this study? To be eligible for this study, at a minimum you must:

  • Be a premenopausal woman 18 to 50 years of age and have normal, regular menstrual cycles that are between 21 and 35 days
  • Be sexually active and have requested contraception (birth control) from your doctor to avoid pregnancy (to be considered “sexually active” in this study you must be having vaginal intercourse at least once per month with a male partner who is not known to be infertile)
  • Have a diagnosis of either uterine fibroids with heavy menstrual bleeding or endometriosis with associated moderate to severe pain
  • Be willing to use an investigational product as the sole method of contraception for one year (for example: condoms, diaphragms, and withdrawal are not allowed)
  • Agree to complete a daily electronic diary (eDiary)
  • You will receive all study-related procedures and the investigational product at no cost.
What is a clinical study?
In a clinical study, participants are assigned to one or more investigational drugs to answer questions about the treatment’s effectiveness and possible side effects.
What is an investigational drug?

An investigational drug is a substance that’s undergoing a clinical study. An ethics committee has reviewed it for testing in people. It may or may not be approved by the government health agency to treat the condition in question.

Why should I take part in this study?
Clinical studies (also called clinical trials) are important for medical advances. Current treatments for diseases are only available because of research study volunteers.
Why is this study important?
In the SERENE study, doctors want to learn more about the safety and effectiveness of the study drug to prevent pregnancy in women 18 to 50 years of age with uterine fibroids or endometriosis.
Pharmaceutical companies use clinical research studies, such as this one, to learn more about investigational drugs before they are available to the public. Study volunteers play a vital role in this critical research. Your involvement is greatly appreciated.
What is the purpose of this study?

This study investigates the study drug to determine its safety and use in preventing pregnancy. A study drug (or investigational drug) is not yet approved for use by the general public.

Who can participate in this study?
To be eligible for this study, you must: 
  • Be a premenopausal woman 18 to 50 years of age and have regular menstrual cycles between every 21 and 35 days.
  • Be sexually active and have requested contraception (birth control) from your doctor to avoid pregnancy. To be considered “sexually active” in this study, you must be having vaginal intercourse at least once per month with a male partner who is not known to be infertile.
  • Have a diagnosis of either uterine fibroids with heavy menstrual bleeding or endometriosis with associated moderate to severe pain.
  • Be willing to use an investigational product as the sole method of contraception for one year (condoms, diaphragms, and withdrawal are not allowed).
  • Agree to complete a daily electronic diary (eDiary).
This is not a complete list of study requirements.
The study doctor will review the full requirements for this study with you.
How long will this study last?
This study will last over two years and requires at least ten on-site visits.
What can I expect if I decide to participate?
If you qualify for the study and decide to participate, you will take the investigational drug orally once daily for up to one year. No other form of birth control (condoms, pills, diaphragms, withdrawal) is allowed during this time. After the one-year treatment is complete, there will be a one-year post-treatment follow-up.
Throughout the study, you will complete an electronic diary (eDiary) questionnaire daily and take a home pregnancy test every 28 days. The study site staff will provide training to fill out the eDiary correctly. They will also discuss taking the study medication and home pregnancy test properly. Ten office visits are required throughout the study. Safety follow-up visits will be conducted by phone approximately six weeks following each on-site visit during the treatment period. During study visits, a medical professional will perform a physical exam. Participants will also occasionally be given assessments and questionnaires to fill out. After the treatment period, the post-treatment follow-up will monitor bone mineral density, which consists of three on-site visits over one year.
Lab tests, physical exams, bone density scans, and other assessments (such as transvaginal ultrasounds or mammograms, if applicable) will be conducted as part of this study.
What are my costs to take part in this study? 
The study is free of charge. We will not ask you to pay for the study drug, supplies, or tests throughout your participation in the research.
What risks are involved if I decide to participate?
There are possible risks involved with any clinical study. Your study doctor will review the risks with you, and you will be closely monitored throughout the study.

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