Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000510549p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2024
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to find out if Myrecil® topical cream can help manage genitourinary symptoms in menopausal women.
Scientific title
A Randomized, Double Blind, Placebo-Controlled Study to evaluate the efficacy and safety of Myrecil® in women with Genitourinary Syndrome of Menopause
Secondary ID [1] 311547 0
Nil known
Secondary ID [2] 311548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genitourinary Syndrome of Menopause (GSM) 332905 0
Condition category
Condition code
Reproductive Health and Childbirth 329619 329619 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Myrecil® 3% , vaginal cream, one 2mg application daily (in the evening) for 56 days. Compliance will be assessed at Day 14 and at each in-clinic visit (D28 and D56) during the treatment period. In addition, at Day 28 and Day 56 the Investigator or designee will also question the participant about whether she has complied with the study dosing regimen and will review the participant completed daily dosing study diary.
Intervention code [1] 328001 0
Treatment: Drugs
Comparator / control treatment
Myrecil®. will be compared to Placebo in a 2:1 ratio.
The placebo will have the same dosage forms, content of excipients, physical appearance and packaging and labelling as the active study drug. The formulation of the placebo contains Water BP, Cetearyl Alcohol BP, Caprylic Capric Triglycerides USP-NF/EP, Polysorbate 60 USP-NF/EP, Phenoxyethanol, Sorbitan stearate USP-NF/EP, Cetyl palmitate USP-NF, Rose Geranium Oil, Yellow dye, Brown dye.
Control group
Placebo

Outcomes
Primary outcome [1] 337408 0
Change from Baseline to Day 56 of vaginal dryness, burning (pain), itching symptoms.
Vaginal dryness, burning (pain), itching symptoms will be assessed as a composite primary outcome
Timepoint [1] 337408 0
VAS Screening (baseline), Day 0, Day 28 and Day56 (primary timepoint) post-initiation of treatment.
Primary outcome [2] 337409 0
Change from Baseline to Day 56 in vaginal health.
Timepoint [2] 337409 0
VHS Screening (baseline) and Day 56 post-initiation of treatment
Secondary outcome [1] 431763 0
Improvement in Quality of Life as assessed by items 1 – 16 on the Vulvovaginal Symptom Questionnaire (VSQ).
Timepoint [1] 431763 0
Screening (baseline) Day 0, Day 28 and Day 56 post-initiation of treatment
Secondary outcome [2] 431764 0
Change from Baseline to Day 56 on Vaginal pH.
Timepoint [2] 431764 0
Screening (baseline), Day 0 and Day 56 post-initiation of treatment.
Secondary outcome [3] 433428 0
Change from Baseline to Day 56 on vaginal pH
Timepoint [3] 433428 0
Screening (baseline), Day 0 and D56 post -initiation of treatment.
Secondary outcome [4] 433429 0
Change from Baseline to Day 56 in VAS score of vaginal dryness
Timepoint [4] 433429 0
Screening (baseline), D0, D28 and D56 post-initiation of treatment
Secondary outcome [5] 433430 0
Adverse Events (AEs) including;
• Incidence of treatment emergent events (TEAEs).
• Serious Adverse Events (SAES)
• Treatment emergent serious adverse events (TESAEs)
• TEAEs leading to discontinuation
Myrecil® has been widely used in skin care products and has a very low risk of side effects. About 0.3% (three in a thousand) reported some allergic response to Myrecil® or the ingredients in the product, To avoid risk of an allergy at the screening visit, an allergy test will be performed, participants will apply about 2g of Myrecil® to the crook of their elbow or inside of the arm, the participant will then be contacted after 48hrs to self-report redness or other potential allergic response to Myrecil®. If an allergic response is reported the participant will not be eligible for the study.
In the studies completed with Myrecil® in patients who had eczema there was a slight weight increase between baseline and V4 (p=0.032), which disappeared by V5.
Timepoint [5] 433430 0
AEs will be recorded from the time of signing the ICF until the final study visit. AEs will be assessed at D0, D28 and D56 post initiation of treatment.

Eligibility
Key inclusion criteria
1. Postmenopausal women as defined by female with amenorrhea for greater than 12 months.
2. Current symptoms of GSM including at least two of the following that have a subjective assessment greater or equal to 4cm on the visual analogue scale: vaginal dryness, burning (pain), itching.
3. A Vestibular Health Score (VHS) greater or equal to 3 to less or equal to 12
4. Capable of giving informed consent.
5. Ambulatory.
6. Capable and willing to follow all study-related procedures.
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are > 65 years of age
2. Use of laser therapy for treatment of GSM at any time in the past.
3. Use of any HRT (systemic or local) or raloxifene within six months of the Screening Visit through study follow up.
4. Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of Investigational product start through study follow up.
5. History of allergic reaction to any component of the study treatment.
6. Pelvic organ prolapse greater than stage II (according to the POP-Q system).
7. Any pelvic surgery within 6 months.
8. Genitourinary bleeding without a definitive diagnosis.
9. Prior vaginal or pelvic irradiation.
10. Active vaginal or urinary tract infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation process is concealed and Central randomization by phone/fax/computer will be used to randomize subjects into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization schedule will be employed to facilitate effective randomization. The schedule will utilise a permuted block randomization technique, randomly assigning participants within blocks based on a 2:1 (Myrecil®:Placebo) allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Forty-five participants will be randomized using a permuted block 2:1 allocation, active Myrecil® to Placebo. A total sample size of 45 participants (30:15) is sufficient to observe effect sizes > 0.9 as statistically significant (two tailed a=0.05) with 80% power.
The co-primary endpoints will be analyzed using an analysis of covariance (ANCOVA). In the analysis, the change in the endpoint to day 56 will be modelled as a function of the fixed treatment group effect and the value of the efficacy variable at baseline (covariate). The appropriateness of this parametric approach will be verified by inspection of the residuals from these models and if the assumptions are not met then comparisons will be undertaken using appropriate non-parametric methods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/05/2024
Actual
Date of last participant enrolment
Anticipated
29/07/2024
Actual
Date of last data collection
Anticipated
15/10/2024
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 26146 0
New Zealand
State/province [1] 26146 0

Funding & Sponsors
Funding source category [1] 315843 0
Commercial sector/Industry
Name [1] 315843 0
WEIR Science Ltd
Country [1] 315843 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
WEIR Science Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 317976 0
None
Name [1] 317976 0
None
Address [1] 317976 0
Country [1] 317976 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314698 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314698 0
Ethics committee country [1] 314698 0
New Zealand
Date submitted for ethics approval [1] 314698 0
16/04/2024
Approval date [1] 314698 0
Ethics approval number [1] 314698 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132434 0
Dr Sylvia Rosevear
Address 132434 0
Mercy Ascott Hospital, 90 Greenlane East Road, Remuera, Auckland, 1051.
Country 132434 0
New Zealand
Phone 132434 0
+64 27 473 3974
Fax 132434 0
Email 132434 0
[email protected]
Contact person for public queries
Name 132435 0
Sylvia Rosevear
Address 132435 0
Mercy Ascott Hospital, 90 Greenlane East Road, Remuera, Auckland, 1051.
Country 132435 0
New Zealand
Phone 132435 0
+64 27 473 3974
Fax 132435 0
Email 132435 0
[email protected]
Contact person for scientific queries
Name 132436 0
Sylvia Rosevear
Address 132436 0
Mercy Ascott Hospital, 90 Greenlane East Road, Remuera, Auckland, 1051.
Country 132436 0
New Zealand
Phone 132436 0
+64 27 473 3974
Fax 132436 0
Email 132436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.