Considering the KYRIAD clinical research study?

If you were diagnosed with functional hypothalamic amenorrhea (FHA), please know that you are not alone in your medical journey. FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly. Women with FHA often have very low body fat, due to using up a lot of energy in exercise or restrictive diets. Therefore, they have low amounts of a hormone called leptin that is made by the fat cells in the body. Low levels of leptin tell the brain that it should not send hormonal signals to the ovaries, and correcting this leptin signal might improve the way the brain and the ovaries are working.

FHA can affect every woman differently. It may be related to weight loss, intense exercise, or ongoing stress. Each cause can affect your body in its own way, which means your needs might be different depending on what’s behind your diagnosis. It’s also important to know that withdrawal bleeding from birth control is not the same as having a natural period. Restoring real menstrual cycles is an important step for your overall health, especially when it comes to protecting your fertility and keeping your bones strong. Getting care can make a real difference.

Currently, we are working on developing a potential treatment for FHA. KYRIAD is a phase 2 clinical research study that aims to see how well the study treatment helps the body restore the menstrual cycle and to assess its safety.

This clinical study is exploring a potential treatment that may support recovery of the menstrual cycle, ovulation and improvement of bone health.

Am I eligible?

What are the study treatments?

Investigational treatment: The study treatment will be administered as a subcutaneous injection (a needle below the skin).

Placebo: A placebo looks like a treatment but does not contain any real medicine. It will be administered the same way as the investigational treatment, as a subcutaneous injection. Researchers can tell whether an investigational treatment is effective by understanding if it works better than a placebo.

Once the study doctor confirms that you qualify, you will be randomly assigned to 1 of 2 treatment groups. You will have a 1 in 2 chance of receiving the study treatment over the placebo.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your role and responsibilities if you join the KYRIAD study. You may leave the study at any time without it affecting your regular health care.

If you join the study, there are certain things you will be expected to do. This includes attending study visits and undergoing certain assessments and procedures, including blood collection, bone scans and gynecological ultrasounds. Your participation may last up to 11 months with about 18 study visits.

Qualified participants may be reimbursed for travel to and from study visits. Medical care related to their participation, including the study treatment, will be provided at no cost. The study team is available to discuss all of this with you.

How can I take part?

If you wish to take part in KYRIAD, you can fill in a short pre-screener questionnaire to see if you may be eligible.

What else should I know?

As with all medicines, there are possible risks when taking the investigational treatment. If you qualify and choose to participate, you will be provided with an Informed Consent Form that explains any possible risks and side effects. It is also possible that the study treatment may affect you in unknown ways. Your health and safety are our top priorities and will be closely monitored throughout your participation.

There is no guarantee that you will receive a medical benefit from participating in this study. Your condition may get better, stay the same, or may even get worse. You are free to withdraw from the study for any reason and at any time.

Please note that this clinical trial will use investigational drug products, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities, and which has not received marketing authorization in any country.

Find a study site near you

To find out more about KYRIAD, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.