Safety and Efficacy of Cannabidiol-coated Tampons for Primary Dysmenorrhea: From Pre-Clinical Data to Post-Market Surveillance
Elena Provaggi1, Nicola Tempest23, Douglas Kell45, Abi Merriel2, Harry Baxter1, Valentina Milanova1*
1Anne’s Day Ltd, London, UK
2Department of Women’s and Children’s Health, University of Liverpool; Liverpool, UK
3Liverpool Women’s National Health Service Foundation Trust; Liverpool, UK
4Institute of Systems, Molecular and Integrative Biology, University of Liverpool; Liverpool, UK
5Department of Physiological Sciences, Stellenbosch University; Stellenbosch, South Africa
*Corresponding author, Anne’s Day Ltd, London, UK. Email address: valentina@yourdaye.com
Affiliationer
Abstract
Primary dysmenorrhea affects an estimated 73% of people who menstruate worldwide. This high global prevalence underscores the need for effective strategies to address the substantial burden of menstrual pain. Despite this, current treatment options remain limited. Cannabidiol (CBD) treatments have been proposed for managing primary dysmenorrhea; however, their safety and efficacy remain largely unstudied. This two-part study presents a comprehensive evaluation of the safety and efficacy of CBD-coated tampons. The first part focuses on preclinical assessments, including irritation, toxic shock syndrome risk, acute systemic toxicity, skin sensitisation, vaginal irritation, and material-mediated pyrogenicity. The second part combines post-market surveillance data, including clinical complications collected from 2019-2024, and survey data collected from 2022-2024, including Manonski pain scores for rating menstrual pain severity prior to and during CBD tampon use. In preclinical assessments, all safety benchmarks were met. A total of 148 clinical complications were reported in relation to CBD-coated tampon use, equating to a prevalence of 0.58% (148/25327, 95% Confidence interval [CI]:0.49 – 0.68%), below the predefined target of <1%. From 42,000 users who were sent the survey, we received 2,123 responses from CBD‑coated tampon users. Before CBD tampon use, the average self-reported Mankoski Pain Score was 6.35 (95% CI: 6.27–6.43, SD = 1.83). During use, mean scores were 3.78 (95% CI: 3.69–3.87, SD = 2.13), representing a mean reduction of 2.57 (95% CI: 2.45–2.69). These findings, corroborated by results from a previously published randomized controlled trial, provide complementary evidence that CBD-coated tampons may offer a safe and effective option for menstrual pain management. Future, large randomised control trials should explore optimum patterns of use of CBD-coated tampons.
Key words
Menstrual pain, primary dysmenorrhea, Cannabidiol, CBD
