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NCT Number: NCT05810116

Effectiveness of PEA Compared to Placebo on Acute Menstrual Pain

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Palmitoylethanolamide (PEA) compared to placebo on menstrual pain in otherwise healthy participants 18 years and over.

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Key information

Conditions

Menstrual Pain Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

RDC Clinical Pty Ltd

New Farm, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who experience mild to moderate menstruating pain
  • Aged 18 years or over
  • History of over the counter (OTC) analgesic use for the treatment of menstrual pain
  • Self-reported history of menstrual cramp pain occurring during four of the past six menstrual cycles.
  • Typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, ibuprofen or acetaminophen taken on at least 1 day of menstrual cycle for the treatment of mild to moderate menstrual cramp, and normally experiences pain relief from these medications.
  • Otherwise healthy
  • Able to provide informed consent
  • Regular menstrual cycle (28 days ± 7 days) and period
  • Agree not to participate in any other clinical trial while enrolled in this trial

Exclusion criteria

  • Secondary cause for dysmenorrhea (i.e. endometriosis, adenomyosis, uterine fibroids or infection)
  • Any bleeding disorders, recent surgery or concurrent blood thinning treatment
  • Unstable or serious illness (e.g., kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma, diagnosed psychological or mood disorder) (1)
  • Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
  • Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
  • Pregnant or lactating women
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  • Chronic past and/or current alcohol use (>14 alcoholic drinks week)
  • Allergic or hypersensitive to any of the ingredients in active or placebo formula
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
  • Participated in any other clinical trial during the past 1 month
  • An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

Treatment and study plan

Levagen+

Drug

Daily dose of 1-2 capsules (1 capsule containing 350mg Levagen+ equivalent to 300mg PEA)

Microcrystalline Cellulose

Drug

Daily dose of 1-2 capsules (1 capsule containing 350mg)

Primary outcomes

  1. Change in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS)

    Time frame: 4 menstrual pain events over a maximum of 16 weeks

    Reduction in acute menstrual pain severity, analgesic effect via Numeric Rating Scale (NRS) a pain assessment tool commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". The higher the score the worse the pain.

Secondary outcomes

  1. Change in categorical pain levels via categorical pain relief scale

    Time frame: 4 menstrual pain events over a maximum of 16 weeks

    Reduction in categorical pain levels via categorical pain relief scale (better, much better, no change, worse, much worse)

  2. Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: 4 menstrual pain events over a maximum of 16 weeks

    Effectiveness of the Treatment via Global Satisfaction scale of the Treatment Satisfaction Questionnaire for Medication (TSQM). To assess the overall level of satisfaction or dissatisfaction with medication patients are taking. Higher scores indicate higher satisfaction.

  3. Change in rescue medication use via self-report

    Time frame: 4 menstrual pain events over a maximum of 16 weeks

    Change in rescue medication use via self-report

  4. Safety of Use

    Time frame: From enrolment and until 4 menstrual pain events are recorded - a maximum of 16 weeks

    Safety via Adverse Event reporting

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study title

Effect of Palmitoylethanolamide (PEA) Compared to a Placebo on Acute Menstrual Pain in an Adult Population - a Double-blind, Crossover, Randomised Controlled Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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