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Trial registered on ANZCTR


Registration number
ACTRN12625000019404
Ethics application status
Approved
Date submitted
19/11/2024
Date registered
13/01/2025
Date last updated
13/01/2025
Date data sharing statement initially provided
13/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Silicone Gel 940 and Estrogen Cream for Treating Genitourinary syndrome of menopause in Women: A Non-Inferiority Study
Scientific title
NICE-940: Non-Inferiority Comparison of Estrogen and Silicone Gel 940 for treating Genitourinary syndrome of menopause. A Non-inferiority Study
Secondary ID [1] 312655 0
None
Universal Trial Number (UTN)
Trial acronym
NICE-940
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genitourinary Syndrome of Menopause 334620 0
Atrophic Vaginitis 334621 0
Condition category
Condition code
Renal and Urogenital 331205 331205 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 332524 332524 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Silicone Gel 940 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 940, 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 silicone gel 940 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 the silicone gel 940 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 940 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 940 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.
Intervention code [1] 329175 0
Treatment: Devices
Intervention code [2] 330080 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 338976 0
Non-inferiority of 940 versus standard of care regarding the patient quality of life (QoL)
Timepoint [1] 338976 0
pretreatment, 30, 60, 90 (primary timepoint) days after post-first dose
Secondary outcome [1] 438171 0
Safety endpoints will be evaluated based on report of product related Adverse Events and subsequent study product interruption.
Timepoint [1] 438171 0
90 days after post-first dose. Adverse events will be only recorded during the final visit, since this is an onsite visit in which patients will be able to report the adverse event to the investigator
Secondary outcome [2] 443241 0
Change in patient symptoms (itching, burning, dryness, pain, discomfort, dyspareunia)
Timepoint [2] 443241 0
The change of patient symptoms will be evaluated at day 0, 30, 60 and 90
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.
Timepoint [3] 443244 0
Change of the genital condition will be evaluated at day 0 and 90, assessed by the investigator in the onsite visits.
Secondary outcome [4] 443245 0
Changes in pathology of the genital condition (genitourinary syndrome of menopause)
Timepoint [4] 443245 0
Change of the pathology of the genital condition will be evaluated at day 0 and 90, assessed by the investigator in the onsite visits.

Secondary outcome [5] 443246 0
Presence of discomfort during intercourse
Timepoint [5] 443246 0
This sympton will be evaluated at day 0, 30, 60 and 90

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

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)
Patients will be randomized 1:1 to either the control or the treatment group in the eCRF software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization with a random block size will be used
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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. 940 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: 940 – Ovestin = 9 (Ovestin superior to 940)
HA1: 940 – Ovestin < 9 (940 not inferior to Ovestin

Reduction in adverse events: proportion of patients that experienced an adverse event. M=0.2 (relative value).
H06: 940 – Ovestin= 0.2 (Ovestin superior to 940)
HA6: 940 – Ovestin < 0.2 (940 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; 940: 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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
18/11/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26890 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 42951 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 317088 0
Commercial sector/Industry
Name [1] 317088 0
Stratpharma AG
Country [1] 317088 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Stratpharma AG
Address
Country
Switzerland
Secondary sponsor category [1] 319344 0
None
Name [1] 319344 0
Address [1] 319344 0
Country [1] 319344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315838 0
Allendale Investigational Review Board
Ethics committee address [1] 315838 0
30 Neck Road Old Lyme, CT 06371
Ethics committee country [1] 315838 0
United States of America
Date submitted for ethics approval [1] 315838 0
30/08/2024
Approval date [1] 315838 0
05/09/2024
Ethics approval number [1] 315838 0

Summary
Brief summary
The main goal of the study is to determine the safety and efficacy of 940 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135958 0
Dr Philip Hall
Address 135958 0
Pelvic Medicine Centre St Andrew’s War Memorial Hospital 457 Wickham Terrace Brisbane Qld 4000
Country 135958 0
Australia
Phone 135958 0
+61 07 3831 0519
Fax 135958 0
Email 135958 0
[email protected]
Contact person for public queries
Name 135959 0
Sofia Rodriguez
Address 135959 0
Stratpharma AG, Aeschenvorstadt 57, 4051, Basel-Stadt, Switzerland
Country 135959 0
Switzerland
Phone 135959 0
+41616911280
Fax 135959 0
Email 135959 0
[email protected]
Contact person for scientific queries
Name 135960 0
Eduardo Serrano
Address 135960 0
Stratpharma AG, Aeschenvorstadt 57, 4051, Basel-Stadt, Switzerland
Country 135960 0
Switzerland
Phone 135960 0
+41616911280
Fax 135960 0
Email 135960 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.