Clinical research programme

Clinical focus on Endometriosis

OMG Pharma is sponsoring a pharmacokinetic and open-label pilot study evaluating cannabidiol (CBD) suppositories for pelvic pain in adults with confirmed endometriosis — conducted with experienced research partners under appropriate human research ethics oversight.

The programme is designed to characterise absorption and physiological effects, assess feasibility and acceptability, and generate exploratory evidence on pain, quality of life and symptom burden over one menstrual cycle.

Background & rationale

Endometriosis is a chronic condition in which tissue similar to the uterine lining grows outside the uterus, often causing pelvic pain, dysmenorrhoea and reduced quality of life. Many people living with endometriosis continue to experience significant symptom burden despite available treatments.

CBD suppositories represent a novel cannabinoid-based formulation designed to provide localised, sustained release of therapeutic compounds directly to the pelvic region. This route of administration may offer distinct pharmacokinetic advantages over oral or systemic delivery, including enhanced bioavailability, reduced first-pass metabolism, and potentially superior tissue penetration to target sites of pain generation.

  • 1 in 10

    Women experience endometriosis

  • 190 Million

    people worldwide experience endometriosis

Study overview

CBD suppositories for endometriosis-associated pain: a pharmacokinetic and open-label pilot study comprises three integrated sub-studies:

  • A pharmacokinetic assessment to characterise the absorption, distribution and preliminary clinical effects of CBD rectal suppositories (75 mg) in individuals with confirmed endometriosis.
  • Transabdominal Doppler ultrasound (TADU) to assess any effect of CBD rectal suppositories on uterine artery perfusion, including pulsatility index (PI) and resistance index (RI), conducted alongside the pharmacokinetic visit.
  • An open-label intervention phase to assess feasibility and indicative subjective clinical responses on pain and quality of life, measured using the Endometriosis Health Profile 30 (EHP-30) and the Most Impactful Symptom of Endometriosis Questionnaire (MSIE-Q), in line with minimum dataset recommendations for endometriosis research.

  • 75 mg

    CBD per suppository dose

  • ~ 10 weeks

    Approximate duration per participant

  • 3

    Integrated sub-studies: pharmacokinetics, ultrasound and open-label pilot

Study objectives

Primary objectives

  • Characterise pharmacokinetic profiles of CBD suppositories following rectal administration, including absorption kinetics, peak plasma concentrations (Cmax), time to peak concentration (Tmax), area under the concentration-time curve (AUC) and elimination half-life.
  • Evaluate feasibility and acceptability of OMG CBD suppositories for pelvic pain management through patient-reported adherence and satisfaction measures.
  • Assess physiological effects on uterine artery perfusion through TADU imaging and explore correlations between plasma cannabinoid levels and uterine PI/RI.

Secondary objectives

  • Investigate impact on endometriosis-specific quality of life, most impactful symptom, work attendance and rescue analgesic medication requirements.
  • Explore effectiveness of once or twice daily 75 mg CBD suppositories in reducing menstrual and non-menstrual pain severity over one complete menstrual cycle.
  • Assess the safety profile of OMG CBD suppositories.

Who can participate

Key inclusion criteria

  • Aged 21 years or older
  • Confirmed endometriosis diagnosis via laparoscopy or expert imaging (TVUS or MRI)
  • Moderate-to-severe dysmenorrhoea requiring medical attention and/or analgesia
  • Regular menstrual cycle (21-35 days) through hormonal regulation (e.g. oral contraceptive with scheduled withdrawal bleeds)
  • Cannabis-naive or willing to abstain from cannabis and other cannabinoid medications for at least 4 weeks before entry and throughout the study
  • Able to attend scheduled visits, including an 8-hour pharmacokinetic sampling day
  • English comprehension sufficient for questionnaires and informed consent

Key exclusion criteria

  • Currently pregnant, breastfeeding or planning pregnancy during the study
  • Unwilling to use appropriate contraception if sexually active with pregnancy potential
  • Known allergy or hypersensitivity to cannabinoids or formulation components
  • Clinically significant abnormal liver or kidney function at screening, or hormonal suppression that does not allow regular withdrawal bleeding
  • Any condition that, in the investigator’s opinion, would compromise safety or data integrity

Full eligibility is determined at screening. This page is an overview only and does not replace the participant information and consent form.

Research collaboration

Meet our research partners

OMG Pharma’s endometriosis programme is delivered with experienced academic investigators under appropriate human research ethics oversight.

Associate Professor Mike Armour

Lead Researcher · NICM Health Research Institute

Associate Professor Mike Armour, PhD

Mike Armour is Associate Professor in Reproductive Health and Director of Research at the NICM Health Research Institute, Western Sydney University. He is an internationally recognised clinical investigator with a focused interest in medicinal cannabis, having led four prior clinical studies in the field and authored more than 140 peer-reviewed publications.

His research informs Australian clinical guidelines and is cited in international evidence-based resources such as UpToDate. Mike leads the clinical research collaboration with OMG Pharma at NICM, Western Sydney University.

NICM Health Research Institute, Western Sydney University

References

  1. World Health Organization (WHO) Endometriosis Fact Sheet, 2023

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Frequently asked questions

What is this study investigating?

OMG Pharma is sponsoring a pharmacokinetic and open-label pilot study evaluating cannabidiol (CBD) suppositories for pelvic pain in adults with confirmed endometriosis. The programme is designed to characterise absorption and physiological effects, assess feasibility and acceptability, and generate exploratory evidence on pain, quality of life and symptom burden over one menstrual cycle.

What does the study involve?

The study comprises three integrated sub-studies:

  • A pharmacokinetic assessment of CBD rectal suppositories (75 mg) in individuals with confirmed endometriosis.
  • Transabdominal Doppler ultrasound (TADU) to assess any effect on uterine artery perfusion, including pulsatility index (PI) and resistance index (RI).
  • An open-label intervention phase assessing feasibility and indicative responses on pain and quality of life using EHP-30 and MSIE-Q.
Who may be eligible to take part?

Key inclusion criteria include being aged 21 years or older, having a confirmed endometriosis diagnosis via laparoscopy or expert imaging (TVUS or MRI), and moderate-to-severe dysmenorrhoea requiring medical attention and/or analgesia. Full eligibility is determined at screening and does not replace the participant information and consent form.

What product format is being studied?

The study is evaluating OMG CBD rectal suppositories at a 75 mg dose, used once or twice daily during the open-label intervention phase. This research is investigational and is intended to generate evidence on pharmacokinetics, feasibility, safety and exploratory clinical outcomes — not to promote product availability.

What outcomes and measures are being assessed?

Primary objectives include characterising pharmacokinetic profiles (including Cmax, Tmax, AUC and elimination half-life), evaluating feasibility and acceptability, and assessing uterine artery perfusion through TADU imaging. Secondary objectives include endometriosis-specific quality of life, most impactful symptom, work attendance, rescue analgesic use, pain severity over one menstrual cycle, and safety.

How is participant safety and ethics oversight managed?

The study is conducted with experienced research partners under appropriate human research ethics oversight. Safety monitoring, informed consent and investigator oversight are embedded throughout the protocol. Approximate duration per participant is around 10 weeks.

How can I register interest or ask a question?

For general enquiries about OMG Pharma endometriosis research, use our contact form or email info@ozmedicann.com. Registering interest does not guarantee eligibility or enrolment in any study.