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MycoMedica 26-MLS101-104


About the Study

This study is indicated for premenopausal adult females living with Premenstrual Dysphoric Disorder (PMDD).

The goal of this study is to assess the safety and tolerability of intermittent low doses of MLS101 (psilocybin) compared with placebo, administered approximately every 72 hours in the luteal phase of the menstrual cycle. This study involves 10 on-site visits, including 6 dosing days, and up to 7 phone call visits. The dosing day appointments are 8 to 9 hours long. Participants are randomized to receive 6 doses of either placebo or MLS101 at 2mg, 4mg, or 6mg.

This study is sponsored by MycoMedica Life Sciences, PBC.


Eligibility

You may be eligible to participate in this study if you:

  • are biologically female and premenopausal

  • are between 18-50 years of age

  • have an existing diagnosis of PMDD and have a history of at least one prior or current medically-supervised treatment for PMDD

  • have regular menstrual cycles to allow estimation of menses onset with accuracy

  • are willing and able to commit to 8-9 hour long dosing days


If chosen for this study, you will be compensated for every study visit that you complete and we can provide transportation if needed.

If you are interested in participating in this clinical trial, please call our friendly staff at 773-989-8313 ext. 116 today. You can also fill out the contact form below.