Menopause and Genitourinary SyndromeGyno-CBDNCT06804889
Effect of CBD-Based Vaginal Suppositories on Menopausal Symptoms
A study testing CANNEFF® VAG SUP vaginal suppositories in people with Menopause and Genitourinary Syndrome, run by Palacky University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Menopause and Genitourinary Syndrome
- What is being tested?
- CANNEFF® VAG SUP vaginal suppositories
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women experiencing (post)menopausal symptoms and absence of microbial infection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause and Genitourinary Syndrome
- Being tested
- CANNEFF® VAG SUP vaginal suppositories, Placebo Suppositories
- Keywords
- menopause, quality of life, cannabidiol, hyaluronic acid, vaginal suppositories
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANNEFF® VAG SUP vaginal suppositoriesDevice
CANNEFF® VAG SUP vaginal suppositories containing 100 mg cannabidiol - CBD and 6.6 mg hyaluronic acid - HA.
Placebo SuppositoriesDevice
Received placebo vaginal suppositories with identical composition as for Active Comparator, but without both active ingredients (CBD - cannabidiol and HA - hyaluronic acid).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Received placebo vaginal suppositories. Receives: Device: Placebo Suppositories |
| CANNEFF® VAG SUP | Active comparator | Received CANNEFF® VAG SUP vaginal suppositories. Receives: Device: CANNEFF® VAG SUP vaginal suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alleviating menopausal symptoms in (post)menopausal women
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).
Measured: 12 months
Improving quality of life in (post)menopausal women
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).
Measured: 12 months
Secondary outcomes (2)
Safety profile evaluation via adverse events reported
The secondary outcome measure was the number of adverse events reported during the study period by patients or physician.
Measured: 12 months
Safety profile evaluation via CA-125 pathology marker analysis
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Menopause and Genitourinary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Collaborators
- CB21 Pharma Ltd.
- Responsible party
- Principal investigator, Jan Vacek, Palacky University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804889
- Sponsor's protocol ID
- 194/22
- Acronym
- Gyno-CBD
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10443245Pisanti 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.
PubMed 28232276Marino 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.
PubMed 23860358
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabidiol-Based Vaginal Suppositories on Menopausal Symptoms: a Randomized Double-Blind Placebo-Controlled Clinical Trial Using MRS and MANSA Questionnaires
- ClinicalTrials.gov ID
- NCT06804889
- Acronym / sponsor ID
- Gyno-CBD / 194/22
- Conditions
- Menopause and Genitourinary Syndrome
- Keywords
- menopause, quality of life, cannabidiol, hyaluronic acid, vaginal suppositories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Collaborators
- CB21 Pharma Ltd.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: Placebo SuppositoriesReceived placebo vaginal suppositories. |
| CANNEFF® VAG SUP | Active comparator | Device: CANNEFF® VAG SUP vaginal suppositoriesReceived CANNEFF® VAG SUP vaginal suppositories. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women experiencing (post)menopausal symptoms and absence of microbial infection.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CANNEFF® VAG SUP vaginal suppositoriesCANNEFF® VAG SUP vaginal suppositories containing 100 mg cannabidiol - CBD and 6.6 mg hyaluronic acid - HA. | Device | CANNEFF® VAG SUP |
| Placebo SuppositoriesReceived placebo vaginal suppositories with identical composition as for Active Comparator, but without both active ingredients (CBD - cannabidiol and HA - hyaluronic acid). | Device | Placebo |
Primary outcome
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).
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).
2 secondary outcomes
Safety profile evaluation via adverse events reported
Time frame: 12 months
Safety profile evaluation via CA-125 pathology marker analysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 10443245Priebe 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.
- Background: PubMed 28232276Pisanti 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.
- Background: PubMed 23860358Marino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CANNEFF® VAG SUP vaginal suppositories in people with Menopause and Genitourinary Syndrome, run by Palacky University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alleviating menopausal symptoms in (post)menopausal women (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804889, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.