Testing a new cannabidiol cream for vulvar pain relief: what the research shows
| ISRCTN | ISRCTN78323046 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78323046 |
| Secondary identifying numbers | SDSM-2024-01.1 |
- Submission date
- 05/07/2025
- Registration date
- 11/07/2025
- Last edited
- 07/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study is looking at a condition called vestibulodynia (VBD), which causes chronic pain around the opening of the vagina. Many women with VBD feel burning, stinging, or sharp pain, especially during sex or when using tampons. The study aims to test whether a gel containing cannabidiol (CBD) and myrcene—two natural substances with anti-inflammatory and pain-relieving properties—can help reduce this pain. Researchers believe that using these ingredients together might work better than using either one alone.
Who can participate?
Women aged 18 or older who have not yet gone through menopause can take part. They must have had VBD for at least six months, experience moderate to severe pain during most sexual activity, and have pain limited to the vestibule (the area around the vaginal opening). Participants must also have a stable sexual partner and be willing to try sexual activity during the study.
What does the study involve?
Participants will be randomly assigned to use either the CBD plus myrcene gel or a placebo gel (which looks the same but has no active ingredients). They will apply the gel once a day for 60 days. The study includes medical exams, pain assessments using rating scales, and questionnaires at the beginning and end of the study. Doctors will also check for any side effects.
What are the possible benefits and risks of participating?
Participants may experience relief from pain and discomfort. However, there is no guarantee of benefit. As with any treatment, there may be side effects, although the gel is expected to be safe. Participants will be monitored closely throughout the study.
Where is the study run from?
Ospedale dei Bambini Vittore Buzzi (Italy)
When is the study starting and how long is it expected to run for?
January 2024 to August 2025.
Who is funding the study?
Italian Vulvodynia Association
Who is the main contact?
Professor Filippo Murina, filippo.murina@unimi.it
Contact information
Public, Scientific, Principal Investigator
Via Castelvetro 24
Milan
20124
Italy
 ORCID ID |
0000-0002-9966-6448 |
|---|---|
| Phone | +390263635420 |
| filippo.murina@unimi.it |
Study information
| Study design | Randomized double blind multicentric controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Efficacy and safety of topical 5% cannabidiol plus myrcene for the treatment of vestibulodynia: a multi-centric randomized controlled trial. RElief with topicaL cannAbinoids for VestibulodyniA |
| Study acronym | RELEVA |
| Study objectives | The Research Hypothesis for the present study is to prospectively document the efficacy and safety of the topical association cannabidiol (CBD) plus myrcene in patients with vestibilodynia (VBD)21. The abundant distribution of cannabinoid receptors on skin nerve fibers and mast cells provides implications for an anti-inflammatory, anti-nociceptive action of cannabinoid receptor agonists and suggests their putatively broad therapeutic potential |
| Ethics approval(s) |
Approved 21/01/2024, V. Buzzi Hospital (Via Castelvetro 24, Milan, 20124, Italy; +390263635420; prenotagine@asst-fbf-sacco.it), ref: protocol code 14/2024 |
| Health condition(s) or problem(s) studied | Tretment of patients with vestibulodynia, the most common manifestation of the vulvodynia |
| Intervention | One or more members of the staff who do not work directly with the subject will be responsible for assignment to active or placebo treatment based on random assignment. The patients will be trained to apply the gel to the vulvar vestibule (2 puff of the dispenser) once a day for 60 days, before the bedtime, with a follow-up after 60 days after the end of therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Cannabidiol (CBD) plus myrcene (brand name Edonelle Plus) |
| Primary outcome measure | 1. Pain intensity is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days 2. Dyspareunia is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days 3. Vestibular pain sensitivity is measured using the cotton swab test at baseline, 60 days, and 120 days 4. Percentage change in pain scores is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days 5. Absolute change in pain scores is measured using a 0–10 point visual analog scale (VAS) at baseline, 60 days, and 120 days |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 21/01/2024 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 100 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Women are at least 18 years of age and premenopausal, defined as having menstruated within the past 12 months 2. Women experience moderate to severe pain, defined as a minimum score of 4 out of 10 on a numeric rating scale, in at least one of three parameters (pain, dyspareunia, or swab test) during at least 90% of sexual intercourse attempts 3. Pain is localized to the vestibule during vaginal intercourse and during activities that exert pressure on the vestibule, such as tampon insertion, wearing tight jeans or pants, cycling, or horseback riding 4. Women have had a diagnosis of vestibulodynia (VBD) for at least 6 months, confirmed using a standardized gynecological examination protocol |
| Key exclusion criteria | 1. Women have active vulvovaginal infections at the time of their gynecological examination 2. Women have genital bleeding of unknown origin 3. Women are concurrently enrolled in other interventional clinical trials 4. Women are unwilling to provide informed consent to participate in the trial 5. Women have used topical drugs in the past 30 days |
| Date of first enrolment | 15/03/2025 |
| Date of final enrolment | 30/03/2025 |
Locations
Countries of recruitment
- Italy
Study participating centres
Milan
20124
Italy
Catania
95124
Italy
Sponsor information
Hospital/treatment centre
Via Castelvetro 24
Milan
20124
Italy
| Phone | +390263635420 |
|---|---|
| prenotagine@asst-fbf-sacco.it | |
| Website | https://ospedaledeibambini.it/noi-e-il-buzzi/ |
"ROR" |
https://ror.org/044ycg712 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to legal and ethical and local institutional rules. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 07/07/2025 | No | No |
Additional files
Editorial Notes
07/07/2025: Trial's existence confirmed by V. Buzzi Hospital.
