Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000019404
Ethics application status
Approved
Date submitted
19/11/2024
Date registered
13/01/2025
Date last updated
22/06/2025
Date data sharing statement initially provided
13/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of StrataMGT and Estrogen Cream for Treating Genitourinary syndrome of menopause in Women: A Non-Inferiority Study
Query!
Scientific title
NICE: Non-Inferiority Comparison of Estrogen and StrataMGT for treating Genitourinary syndrome of menopause. A Non-inferiority Study
Query!
Secondary ID [1]
312655
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
NICE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Genitourinary Syndrome of Menopause
334620
0
Query!
Atrophic Vaginitis
334621
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
332524
332524
0
0
Query!
Menstruation and menopause
Query!
Renal and Urogenital
331205
331205
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
StrataMGT for the treatment of Genitourinary Syndrome of Menopause
The trial for the treatment of Genitourinary Syndrome of Menopause involves the use of a silicone-based gel known as StrataMGT, which forms a protective and hydrating membrane over the skin, aiming to reduce symptoms such as dryness, itching, burning, and discomfort during intercourse. Participants will receive informational materials including a patient information leaflet and detailed care instructions provided by the research coordinator. The intervention will be delivered by trained healthcare providers with relevant expertise, such as gynecologists or research nurses. These interactions will consist of a clinical examination of the area (around 15 minutes) and completion of a questionnaire (5-10 minutes).
Study personnel will receive training by thoroughly reviewing the study protocol. No additional training will be required for vaginal examinations, as these are standard routine procedures. For product application, research coordinators will be trained using the Patient Information Leaflet (PIL). During the Site Initiation Visit, the sponsor will provide a comprehensive explanation to ensure proper application of the product.
The mode of delivery will be a combination of face-to-face interactions during on-site visits and digital communication for online self-assessments. Participants will have two on-site visits (at the start and end of the study) and will complete two online self-assessments during the treatment period. The intervention will be administered individually, with participants using the gel as directed for three months.
Each participant will undergo a baseline assessment, after which they will be randomly assigned to receive either the StrataMGT or the estrogen vaginal cream Ovestin. The study includes a potential wash-out month for those currently on estrogen therapy, followed by the three-month treatment period. The location for on-site assessments will be a designated medical facility, while online assessments can be completed at the participants' convenience.
The intervention involves applying StrataMGT to the affected area at least twice daily for continuous contact, 24 hours a day, 7 days a week, over a period of three months. Participants should wash their hands before applying 3 to 5 drops of StrataMGT intravaginally and distribute it evenly. Additional applications are recommended after each urination, bowel movement, or wash, and the gel can be reapplied as needed throughout the day to ensure constant contact with the mucosa or skin and to reduce symptoms. No drying, rubbing, or massaging is required as the gel does not penetrate the mucosa or skin. This regimen is maintained long-term to support mucosal health
The study aims to enroll 100 female patients, who will be evaluated based on treatment success with either StrataMGT or Ovestin. Participants are required to adhere to the treatment regimen, complete monthly online questionnaires, and return all study products at the end of the study. This comprehensive approach ensures the accurate assessment of the investigational product's effectiveness compared to the control product.
Query!
Intervention code [1]
330080
0
Treatment: Other
Query!
Intervention code [2]
329175
0
Treatment: Devices
Query!
Comparator / control treatment
Ovestin cream is a hormonal replacement therapy. It is applied intravaginally to alleviate dryness, itching, and discomfort while supporting the restoration of the vaginal mucosa. Clinical studies have demonstrated its efficacy in improving symptoms with a favorable safety profile when used as directed.
At the start of the treatment, 1 g of cream (marked on the applicator) should be applied to the internal area daily for two weeks. Afterwards, the frequency of application should be reduced to 1 g of cream, two times a week until the end of the trial.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
338976
0
Non-inferiority of StrataMGT versus standard of care regarding the patient quality of life (QoL)
Query!
Assessment method [1]
338976
0
Vulvar Disease Quality of Life (VDQLI) Index questionnaire
Query!
Timepoint [1]
338976
0
The primary endpoint of this study is the change from baseline to Day 90 ±7 days (Week 12).
Query!
Secondary outcome [1]
443246
0
Presence of discomfort during intercourse
Query!
Assessment method [1]
443246
0
Dyspareunia is rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible.
Query!
Timepoint [1]
443246
0
This sympton will be evaluated at day 0, and months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Query!
Secondary outcome [2]
443241
0
Change in patient symptoms (itching, burning, dryness, pain, discomfort, dyspareunia)
Query!
Assessment method [2]
443241
0
Symptoms are rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible.
Query!
Timepoint [2]
443241
0
Change of patient symptoms will be evaluated at baseline and months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Query!
Secondary outcome [3]
443244
0
Changes in overall genital condition. The following parameters will be systematically evaluated: Dryness (lack of mucosal hydration) Tissue thinning (atrophic changes in the genital mucosa) Erosion/Ulcers (presence of superficial or deeper tissue disruptions) Fissures (linear cracks or breaks in the mucosa) Erythema (redness indicative of inflammation or irritation) Scarring/Adhesion (fibrotic changes or tissue adherence affecting anatomy) Contact bleeding (bleeding upon gentle manipulation or examination) Labial fusion (partial or complete adhesion of the labia) Labial reabsorption (loss or reduction of labial tissue volume) Contracture of the posterior introitus (narrowing or fibrosis of the vaginal opening) Other relevant findings as observed during the clinical examination These parameters will be documented descriptively in the medical records, with severity graded based on clinical judgment.
Query!
Assessment method [3]
443244
0
Signs are rated by the investigator during baseline and at all onsite visits (3, 6, 9 and 12 months), using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible.
Query!
Timepoint [3]
443244
0
Change of the genital condition will be evaluated at day 0 and at months 3, 6, 9 and 12, assessed by the investigator in the onsite visits.
Query!
Secondary outcome [4]
443245
0
Changes in pathology of the genital condition (genitourinary syndrome of menopause)
Query!
Assessment method [4]
443245
0
Severity of the visual pathology is rated by the investigator during baseline and at all onsite visits, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. Dryness (lack of mucosal hydration) Tissue thinning (atrophic changes in the genital mucosa) Erosion/Ulcers (presence of superficial or deeper tissue disruptions) Fissures (linear cracks or breaks in the mucosa) Erythema (redness indicative of inflammation or irritation) Scarring/Adhesion (fibrotic changes or tissue adherence affecting anatomy) Contact bleeding (bleeding upon gentle manipulation or examination) Labial fusion (partial or complete adhesion of the labia) Labial reabsorption (loss or reduction of labial tissue volume) Contracture of the posterior introitus (narrowing or fibrosis of the vaginal opening) Other relevant findings as observed during the clinical examination
Query!
Timepoint [4]
443245
0
Change of the pathology of the genital condition will be evaluated at day 0 and at months 3, 6, 9 and 12, assessed by the investigator in the onsite visits.
Query!
Secondary outcome [5]
438171
0
Safety endpoints will be evaluated based on report of product related Adverse Events and subsequent study product interruption.
Query!
Assessment method [5]
438171
0
Incidence of Adverse Events. This will be done during the clinical assessments, patients will inform the investigator about any possible adverse event they have experienced using the product
Query!
Timepoint [5]
438171
0
3, 6, 9 and 12 months after first dose
Query!
Eligibility
Key inclusion criteria
• Able to provide informed consent
• Confirmed postmenopausal age
• Diagnosed genitourinary syndrome of menopause
• Access to a smartphone, tablet or computer, and to a functional email address.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
• Contraindication for the use of estrogen therapy
• Unable to provide informed consent
• Patient unable to apply topical device
• Allergy or intolerance to ingredients or excipients of the formulation of studied products
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomized 1:1 to either the control or the treatment group in the eCRF software.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization with a random block size will be used
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Analysis will be performed by Stratpharma using standard statistical protocols.
Data will be pooled by groups and will be analyzed using descriptive statistics, i.e. mean and standard deviation.
Demographic information will be described using mean, standard deviation, or minimum and maximum (range), percentages or frequency tables, where appropriate.
Analyses will be adapted by the needs of the Sponsor or the principal investigator.
No studies evaluating the effect of Ovestin vs. placebo are available to date. Thus the non-inferiority margin (M) is based on expert opinion and the statistical outcomes of the pilot study with 10 patients (ref Winter). The maximum acceptable difference (non-inferiority margin M) between the mean treatment effect of Ovestin vs. StrataMGT is set to M=20% of the total scale score; i.e. on a scale from 0 – 10, M = 2.
Primary efficacy outcome, null and alternative hypotheses will be tested as follows:
- Improvement in quality of life: measured on a scale from 0=normal to 45=worst possible. M=9.
H01: StrataMGT – Ovestin = 9 (Ovestin superior to StrataMGT)
HA1: StrataMGT – Ovestin < 9 (StrataMGT not inferior to Ovestin
Reduction in adverse events: proportion of patients that experienced an adverse event. M=0.2 (relative value).
H06: StrataMGT – Ovestin= 0.2 (Ovestin superior to StrataMGT)
HA6: StrataMGT – Ovestin < 0.2 (StrataMGT not inferior to Ovestin)
Intention-to-Treat (ITT) Analysis Dataset: all study participants that received any study product.
• Per-Protocol Analysis Dataset: all study participants, that completed the study as per protocol and had used the product as directed (Ovestin: min. 3x per week; StrataMGT: 2x daily).
• Safety Analysis Dataset: all study participants
The proposed formal design will be an unblinded randomized, controlled study.
Descriptive statistics of categorical and continuous data will be presented with percentages, means with standard deviations and/or range (min.-max.).
All confidence intervals are calculated at the designated level of 95%, using two-tailed tests at a significance level of a=5%.
Descriptive
Inferential statistics (confident intervals, standard error)
Student t-test / Wilcoxon signed-rank test
ANOVA / Friedman test
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/07/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
18/11/2026
Query!
Actual
Query!
Sample size
Target
100
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
26890
0
St Andrew's War Memorial Hospital - Brisbane
Query!
Recruitment postcode(s) [1]
42951
0
4000 - Brisbane
Query!
Funding & Sponsors
Funding source category [1]
317088
0
Commercial sector/Industry
Query!
Name [1]
317088
0
Stratpharma AG
Query!
Address [1]
317088
0
Query!
Country [1]
317088
0
Switzerland
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Stratpharma AG
Query!
Address
Query!
Country
Switzerland
Query!
Secondary sponsor category [1]
319344
0
None
Query!
Name [1]
319344
0
Query!
Address [1]
319344
0
Query!
Country [1]
319344
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315838
0
Allendale Investigational Review Board
Query!
Ethics committee address [1]
315838
0
30 Neck Road Old Lyme, CT 06371
Query!
Ethics committee country [1]
315838
0
United States of America
Query!
Date submitted for ethics approval [1]
315838
0
30/08/2024
Query!
Approval date [1]
315838
0
05/09/2024
Query!
Ethics approval number [1]
315838
0
Query!
Summary
Brief summary
The main goal of the study is to determine the safety and efficacy of StrataMGT in the management of genitourinary syndrome of menopause. The primary objective of this study is to assess the improvement on patient quality of life for patients treating genitourinary syndrome of menopause with 940 compared to standard of care.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
135958
0
Dr Philip Hall
Query!
Address
135958
0
Pelvic Medicine Centre St Andrew’s War Memorial Hospital 457 Wickham Terrace Brisbane Qld 4000
Query!
Country
135958
0
Australia
Query!
Phone
135958
0
+61 07 3831 0519
Query!
Fax
135958
0
Query!
Email
135958
0
[email protected]
Query!
Contact person for public queries
Name
135959
0
Sofia Rodriguez
Query!
Address
135959
0
Stratpharma AG, Aeschenvorstadt 57, 4051, Basel-Stadt, Switzerland
Query!
Country
135959
0
Switzerland
Query!
Phone
135959
0
+41616911280
Query!
Fax
135959
0
Query!
Email
135959
0
[email protected]
Query!
Contact person for scientific queries
Name
135960
0
Eduardo Serrano
Query!
Address
135960
0
Stratpharma AG, Aeschenvorstadt 57, 4051, Basel-Stadt, Switzerland
Query!
Country
135960
0
Switzerland
Query!
Phone
135960
0
+41616911280
Query!
Fax
135960
0
Query!
Email
135960
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
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.
Download to PDF