Clinical trial NCT06804889: Effect of CBD-Based Vaginal Suppositories on Menopausal Symptoms
Official title: Effect of Cannabidiol-Based Vaginal Suppositories on Menopausal Symptoms: a Randomized Double-Blind Placebo-Controlled Clinical Trial Using MRS and MANSA Questionnaires
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause and Genitourinary Syndrome
Keywords: menopause, quality of life, cannabidiol, hyaluronic acid, vaginal suppositories
Lead sponsor: Palacky University
Sponsor class: OTHER
Collaborators: name: CB21 Pharma Ltd.
First posted: 2025-02-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Efficacy and safety of the medical device CANNEFF® vaginal suppositories containing two active ingredients cannabidiol (CBD) and hyaluronic acid (HA) in alleviating menopausal symptoms and improving quality of life in (post)menopausal women will be evaluated.

Detailed description: Current state of the art: Menopause is a significant transitional phase in a woman's life, marked by the cessation of ovarian function and a decline in estrogen levels, typically occurring between the ages of 40 and 55. This hormonal shift leads to various physiological and psychological symptoms, including hot flashes, sleep disturbances, mood swings, anxiety, depression, fatigue, and sexual dysfunction. These symptoms can profoundly impact daily activities and interpersonal relationships.

Study description: The study was designed as a randomised, double-blind, placebo-controlled clinical trial conducted at the Gynaecology and Obstetrics Clinic Meda, Prague 8, Czech Republic. The study adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines and the principles of the Declaration of Helsinki (1975, revised in 2013). Baseline assessments included MRS, MANSA questionnaires, hormone levels (FSH, LH, estradiol), and the CA-125. These assessments were repeated at the end of the 30-day treatment period for the MRS, MANSA scores, and CA-125 analysis. The primary outcome measures were the changes in MRS and MANSA scores from baseline to post-treatment. Secondary outcomes included changes in the CA-125 marker, as well as any adverse events reported during the study period.

Recruitment and study: Post/menopausal women presenting with significant climacteric symptoms and reporting partner sexual discomfort were initially assessed. Inclusion criteria included women older than 40y experiencing (post)menopausal symptoms and absence of microbial infection. Exclusion criteria included a history of gynaecological oncology, diabetes, current treatment with antidepressants, antibiotics, or any contraindications to vaginal suppository use, as well as users of cannabis or cannabis products.

Intervention: Participants were randomized into two groups: Group A received CANNEFF® vaginal suppositories containing 100 mg CBD and 6.6 mg HA per one suppository, and Group B received placebo suppositories of identical composition without the active ingredients. Both groups used one suppository for nightly for 30 days.

Evaluation of study results: Pre-treatment and post-treatment assessments included the Menopause Rating Scale (MRS) and the Manchester Short Assessment of Quality of Life (MANSA) validated questionnaires and the CA-125 marker monitoring. Hormone levels (FSH, LH, estradiol) were measured during pre-treatment assessments to confirm menopausal status. Secondary outcomes included changes in the CA-125 marker and any adverse events reported during the study.

Eligibility criteria: Inclusion Criteria:

Women experiencing (post)menopausal symptoms and absence of microbial infection.

Exclusion Criteria:

Women with history of gynaecological oncology, diabetes, current treatment with antidepressants, antibiotics, or any contraindications to vaginal suppository use, as well as users of cannabis or cannabis products.

Primary outcomes:
measure: Alleviating menopausal symptoms in (post)menopausal women
timeFrame: 12 months
measure: Improving quality of life in (post)menopausal women
timeFrame: 12 months
Secondary outcomes:
measure: Safety profile evaluation via adverse events reported
timeFrame: 12 months
measure: Safety profile evaluation via CA-125 pathology marker analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague 8
country: Czech Republic
facility: Gynaecology and Obstetrics Clinic Meda
state: Czechia
Study officials:
References:
citation: Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.
citation: Pisanti S, Malfitano AM, Ciaglia E, Lamberti A, Ranieri R, Cuomo G, Abate M, Faggiana G, Proto MC, Fiore D, Laezza C, Bifulco M. Cannabidiol: State of the art and new challenges for therapeutic applications. Pharmacol Ther. 2017 Jul;175:133-150. doi: 10.1016/j.pharmthera.2017.02.041. Epub 2017 Feb 22.
citation: Marino JL, Saunders CM, Emery LI, Green H, Doherty DA, Hickey M. Nature and severity of menopausal symptoms and their impact on quality of life and sexual function in cancer survivors compared with women without a cancer history. Menopause. 2014 Mar;21(3):267-74. doi: 10.1097/GME.0b013e3182976f46.