NCT06804889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 20, 2025

Last Update Submit

January 27, 2025

Conditions

Menopause and Genitourinary Syndrome

Keywords

menopause, quality of life, cannabidiol, hyaluronic acid, vaginal suppositories

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    12 months

Secondary Outcomes (2)

  • Safety profile evaluation via adverse events reported

    12 months

  • Safety profile evaluation via CA-125 pathology marker analysis

    12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Received placebo vaginal suppositories.

Device: Placebo Suppositories

CANNEFF® VAG SUP

ACTIVE COMPARATOR

Received CANNEFF® VAG SUP vaginal suppositories.

Device: CANNEFF® VAG SUP vaginal suppositories

Interventions

CANNEFF® VAG SUP vaginal suppositoriesDEVICE

CANNEFF® VAG SUP vaginal suppositories containing 100 mg cannabidiol - CBD and 6.6 mg hyaluronic acid - HA.

CANNEFF® VAG SUP
Placebo SuppositoriesDEVICE

Received placebo vaginal suppositories with identical composition as for Active Comparator, but without both active ingredients (CBD - cannabidiol and HA - hyaluronic acid).

Placebo

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological female identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecology and Obstetrics Clinic Meda

Prague, Czechia, 180 00, Czechia

Location

Related Publications (3)

  • 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.

    PMID: 10443245BACKGROUND

  • 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.

    PMID: 28232276BACKGROUND

  • 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.

    PMID: 23860358BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Olomouc University Hospital

Study Record Dates

First Submitted

January 20, 2025

First Posted

February 3, 2025

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)