Menu
Recruiting NCT07271030

The Use of Cannabidiol Suppositories for Sexual Pain

No phase Interventional Well-Being, Psychological Quality of Life Sexual Behavior Sexual Pain Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabidiol suppository intervention 1, Cannabidiol suppository intervention 2, Cannabidiol suppository intervention 3, Non cannabidiol group control.
Who it may be relevant to
Registry conditions: Well-Being, Psychological, Quality of Life, Sexual Behavior, Sexual Pain Disorder. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Use of Cannabidiol Suppositories for Sexual Pain: A Randomised Controlled Study

Overview

Research aim: To determine how cannabidiol suppositories might reduce sexual pain during intimacy. Outcomes are also hoped to increase sexual functioning, well-being, and quality of life. Research intention: If cannabidiol suppository intervention reduces sexual pain and increases general well-being, then this research would be repeated on a larger scale, targeting psychosexual services. A brief overview of the intervention: Quantitatively, randomisation of cannabidiol suppositories will be into dose-specific groups. The intervention will be delivered over a period of one month, with follow-up scheduled at 12 weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.

Detailed description

Sexual pain is a constellation of biopsychosocial disorders which affects men, women and their partners.

Cannabidiol is one of approximately 100 cannabinoids found in cannabis, alongside tetrahydrocannabinol. Cannabidiol is non-intoxicating and regarded as a safe product to use. Cannabidiol has many applications, including in sexual health. Two studies have examined cannabidiol suppositories for supporting sexual function and reducing sexual pain. In both studies, outcomes suggested the pain relieving qualities of cannabidiol oil for both men and women.

This research aims to establish the effectiveness of varied doses of cannabidiol oil to minimise sexual pain and increase well-being. This research is a preliminary study looking at how cannabidiol suppositories aim to reduce pain and support sexual function, wellbeing and quality of life among those experiencing sexual discomfort or pain during intercourse or masturbation.

There will be four groups, where cannabidiol will be randomised to dose-specific groups, approximately 30, 50, and 100mg, under the guidance of a medical practitioner. There will also be a care as usual group.

It is hypothesised that:

Higher levels of sexual functioning, quality of life and wellbeing with lower levels of sexual pain will be reported among those using cannabidiol suppositories at the follow-up after intervention compared to care as usual group.

It is further hypothesised that higher doses of cannabidiol suppositories will have higher levels of sexual pain-reducing outcomes.

Interventions

  • Dietary supplement Cannabidiol suppository intervention 1
    Cannabidiol suppository dose specific 30mg
  • Dietary supplement Cannabidiol suppository intervention 2
    Cannabidiol suppository dose specific 50mg
  • Dietary supplement Cannabidiol suppository intervention 3
    Cannabidiol suppository dose specific 100mg
  • Other Non cannabidiol group control
    Care as usual group

Primary outcome measures

  • The Female Sexual Function Index [Time frame: 0, 4 and 12 weeks]
  • The Short Warwick Edinburgh Mental Well-being Scale [Time frame: 0, 4 and 12 weeks]
  • Brief Quality of Life Scale [Time frame: Weeks 0, 4 and 12]
  • Changes in levels of anal pain taken [Time frame: Weeks 0, 4 and 12]

Eligibility criteria

Inclusion criteria

  • Has previously used cannabidiol in any capacity and has not experienced any allergic reaction
  • Is experiencing sexual pain
  • There will be an absence of co occurring difficulties
  • Has attempted sexual intercourse in the last month
  • Age 18 years or older
  • Read and write English
  • Patient Health Questionnaire 9 screening score range between 0-9 mild
  • General Anxiety Disorder 7 screening score range between 0-9 mild
  • There are no restrictions on sex, gender, sexuality, or disability

Exclusion criteria

Has experienced an allergic reaction to cannabidiol in any capacity

  • Has not attempted sexual intercourse in the last month
  • Has co occurring difficulties
  • Aged below 18 years old
  • Are not experiencing sexual pain
  • Patient Health Questionnaire 9 screening score range between moderate to severe - 10-27
  • General Anxiety Disorder 7 screening score range between 10- 21.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • School of Social Sciences and Professions — London

Publications

  • Mitchell KR, Geary R, Graham CA, Datta J, Wellings K, Sonnenberg P, Field N, Nunns D, Bancroft J, Jones KG, Johnson AM, Mercer CH. Painful sex (dyspareunia) in women: prevalence and associated factors in a British population probability survey. BJOG. 2017 Oct;124(11):1689-1697. doi: 10.1111/1471-0528.14518. Epub 2017 Jan 25. PMID 28120373
  • Nimbi FM, Rossi V, Tripodi F, Luria M, Flinchum M, Tambelli R, Simonelli C. Genital Pain and Sexual Functioning: Effects on Sexual Experience, Psychological Health, and Quality of Life. J Sex Med. 2020 Apr;17(4):771-783. doi: 10.1016/j.jsxm.2020.01.014. Epub 2020 Feb 13. PMID 32063471
  • Lo LA, Christiansen AL, Strickland JC, Pistawka CA, Eadie L, Vandrey R, MacCallum CA. Does acute cannabidiol (CBD) use impair performance? A meta-analysis and comparison with placebo and delta-9-tetrahydrocannabinol (THC). Neuropsychopharmacology. 2024 Aug;49(9):1425-1436. doi: 10.1038/s41386-024-01847-w. Epub 2024 Mar 25. PMID 38528133
  • Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e. PMID 20393420
  • Damon W, Rosser BR. Anodyspareunia in men who have sex with men: prevalence, predictors, consequences and the development of DSM diagnostic criteria. J Sex Marital Ther. 2005 Mar-Apr;31(2):129-41. doi: 10.1080/00926230590477989. PMID 15859372
  • Haroutounian S, Ratz Y, Ginosar Y, Furmanov K, Saifi F, Meidan R, Davidson E. The Effect of Medicinal Cannabis on Pain and Quality-of-Life Outcomes in Chronic Pain: A Prospective Open-label Study. Clin J Pain. 2016 Dec;32(12):1036-1043. doi: 10.1097/AJP.0000000000000364. PMID 26889611
  • Rosser BR, Short BJ, Thurmes PJ, Coleman E. Anodyspareunia, the unacknowledged sexual dysfunction: a validation study of painful receptive anal intercourse and its psychosexual concomitants in homosexual men. J Sex Marital Ther. 1998 Oct-Dec;24(4):281-92. doi: 10.1080/00926239808403963. PMID 9805288
  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PMID 10782451

Identifiers

NCT: NCT07271030 · LondonsMUSB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗