Effect of CBD-Based Vaginal Suppositories on Menopausal Symptoms (Gyno-CBD)

January 27, 2025 updated by: Jan Vacek, Palacky University

Effect of Cannabidiol-Based Vaginal Suppositories on Menopausal Symptoms: a Randomized Double-Blind Placebo-Controlled Clinical Trial Using MRS and MANSA Questionnaires

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
    • Czechia
      • Prague 8, Czechia, Czech Republic, 180 00
        • Gynaecology and Obstetrics Clinic Meda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Received placebo vaginal suppositories.
Device: Placebo Suppositories
Received placebo vaginal suppositories with identical composition as for Active Comparator, but without both active ingredients (CBD - cannabidiol and HA - hyaluronic acid).
Active Comparator: CANNEFF® VAG SUP
Received CANNEFF® VAG SUP vaginal suppositories.
Device: CANNEFF® VAG SUP vaginal suppositories
CANNEFF® VAG SUP vaginal suppositories containing 100 mg cannabidiol - CBD and 6.6 mg hyaluronic acid - HA.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alleviating menopausal symptoms in (post)menopausal women
Time Frame: 12 months
The primary outcome measure was the changes in MRS (Menopause Rating Scale) scores from baseline to post-treatment. The MRS questionnaire covers 11 symptoms in somatic-vegetative, psychological and urogenital domains. The respondents evaluate the intensity of the various symptoms using a Likert scale 0-4 (0 - none; 1 - minor; 2 - medium; 3 - major; 4 - unbearable difficulties).
12 months
Improving quality of life in (post)menopausal women
Time Frame: 12 months
The primary outcome measure was the changes in MANSA (Manchester Short Assessment of Quality of Life) scores from baseline to post-treatment. 16-item questionnaire evaluating quality of life was used, rated from 1 (could not be worse) to 7 (could not be better).
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety profile evaluation via adverse events reported
Time Frame: 12 months
The secondary outcome measure was the number of adverse events reported during the study period by patients or physician.
12 months
Safety profile evaluation via CA-125 pathology marker analysis
Time Frame: 12 months
The secondary outcome measure was the changes in CA-125 marker monitored. CA-125 is a pathology marker commonly used in gynecology, with a reference range of 0 to 35 kU/L. Within this range = no pathology during the intervention. The value > 35 kU/L = pathological changes during the intervention.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Palacky University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CB21 Pharma Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 194/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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