An Open-Label, Non-Randomized Trial of a High-Cannabidiol Suppository for Menstrual-Related Pain and Discomfort

The endocannabinoid system is involved in both natural and pathological gynecological functions, indicating potential for cannabinoid-based therapies. Cannabidiol (CBD) is a promising cannabinoid for alleviating menstrual-related pain and discomfort; however, thus far, no clinical trials have been conducted. This open-label, non-randomized, trial was conducted as a national survey, and assessed PRN use of a hemp-derived, broad-spectrum, high-CBD (100mg) vaginal suppository (Foria®) for menstrual-related pain and discomfort compared to a treatment-as-usual (TAU) group (CBD n=77, TAU n=230). Assessments were collected at baseline and two monthly follow-ups (~2 menstrual cycles). After completing baseline assessments, participants were provided with information to receive study product directly from the study sponsor (Foria®) but were not required to use the product. This study design was necessary due to federal regulations preventing the principal investigator from administering the study product to participants. Results indicated the CBD group demonstrated significantly reduced frequency and severity of menstrual-related symptoms, impact of symptoms on daily functioning, need for analgesics, and number of analgesics used relative to the TAU group (ps ≤.017). Most CBD participants reported at least moderate improvement of symptoms (follow-up 1=72.9%, follow-up 2=81.1%). The CBD group reported greater improvement of symptoms during menstruation including pain, concentration, behavioral changes, autonomic reactions, water retention, and negative affect (ps ≤.032); improvement of premenstrual symptoms was also noted for behavioral changes and autonomic reactions (ps ≤.007). Increased number of suppositories used was significantly associated with greater reduction of menstrual-related symptoms, impact of symptoms on daily functioning, and need for analgesics (ps ≤.017). Results provide preliminary evidence supporting the efficacy of a broad-spectrum, high-CBD suppository to address a range of menstrual-related symptoms with correlation analyses indicating a potential dose-dependent response. Future studies (including randomized trials) assessing pharmacokinetics/pharmacodynamics, mechanism(s) of action, efficacy for other gynecological indications, and potential adverse events (e.g., drug-drug interactions) are indicated.