Cannabidiol use in women with endometriosis and chronic pelvic pain: evaluation in pain and quality of life

Cannabidiol use in women with endometriosis and chronic pelvic pain: a randomized duble-blind clinical trial for evaluation in pan and quality of life

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-6ryrpjs

Enrollment

Unknown

Registered

2021-05-28

Start date

2020-12-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, pelvic pain

Interventions

The evaluation will be with 30 patients, divided into two groups: one treated with Cannabidiol and another control receiving placebo, each one with 15 patients. The proposed medication will be HempFl

D26.660

D02.455.849.090.100

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients diagnosed with endometriosis, with an suggestive image exam, who maintain pain (visual analogue scale more than 5) even in the course of drug treatment with hormonal contraceptives for at least 3 months before the inclusion of the study

Exclusion criteria

Exclusion criteria: Other types of clinical hormonal treatment (anastrozole, gestrinone, GnRh analogue); patients undergoing complementary treatment with physiotherapy, acupuncture, meditation; patients using other herbal medicines (Uncaria tomentosa); patients planning to become pregnant, pregnant and / or lactating women; patients with allergies to medication components; patients with psychiatric disorders; patients with liver disease, heart disease and / or kidney disease; patients taking medications with potential interactions (clonazepam, n-desmethylclobazam, topiramate, stiripentol, zonizamide, eslicarbazepine, rufinamide)

Design outcomes

Primary

Measure	Time frame
To evaluate the use of Cannabidiol, derived from Cannabis sativa, in response to pain and quality of life in patients with endometriosis. The success criteria will be considered according to the responses to the questionnaires, such as a greater than 50% decrease in pain on the visual analog scale (VAS) and the statistical variation found in the responses to the Quality of Life Questionnaire focused on endometriosis (EHP 30 - Endometriosis Health Profile Questionnaire - translated and validated into Portuguese).	—

Measure

Time frame

To evaluate the use of Cannabidiol, derived from Cannabis sativa, in response to pain and quality of life in patients with endometriosis. The success criteria will be considered according to the responses to the questionnaires, such as a greater than 50% decrease in pain on the visual analog scale (VAS) and the statistical variation found in the responses to the Quality of Life Questionnaire focused on endometriosis (EHP 30 - Endometriosis Health Profile Questionnaire - translated and validated into Portuguese).

—

Secondary

Measure	Time frame
Indirect efficacy will also be assessed through the reported use of rescue medications and even the need to hospital care via the first aid for medications, to be informed in a report completed by the patient during the study.	—

Countries

Brazil

Contacts

Public ContactThaís Federico

drathais.ginecologia@gmail.com+55 11 99616 2659

Outcome results

None listed

Source: REBEC (via WHO ICTRP)