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Trial registered on ANZCTR


Registration number
ACTRN12625000085471p
Ethics application status
Submitted, not yet approved
Date submitted
26/11/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of the Estriol Eluting (E-Leviate) Vaginal Pessary to Treat Pelvic Organ Prolapse in Postmenopausal Women with Symptomatic Pelvic Organ Prolapse.
Scientific title
Safety and Efficacy of the Estriol Eluting Vaginal Pessary (E-Leviate) to Treat Pelvic Organ Prolapse in Postmenopausal Women with Symptomatic Pelvic Organ Prolapse.
Secondary ID [1] 313446 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse (POP) 335843 0
Genitourinary syndrome of menopause (GSM) 335844 0
Condition category
Condition code
Renal and Urogenital 332421 332421 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 332422 332422 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an early (phase IIb), unblinded, investigator led, proof-of-concept clinical intervention trial aiming to assess the safety and tolerability profiles of estriol eluting vaginal pessary as a non-surgical treatment for women with pelvic organ prolapse.

The Investigational Medicinal Product (IMP) is a homogenous vaginal pessary made of the chemically inert biocompatible silicone elastomer (MED-4470, Nusil) and loaded with the active pharmaceutical ingredient (API) estriol at a low concentration (1%w/w). The IMP carries potential clinical benefits for managing vaginal atrophy in menopausal women. It is the first to offer hormonal replacement and mechanical support. It will be provided in two ring sizes: 57mm and 69mm with the same drug profile.

Dose: sustained release of low estriol doses (0.00330-0.00550 mug/day)
Duration: 6 months
Mode: Vaginal pessary remaining insitu

The intervention will not be personalised. The size of vaginal pessary used for participants (57mm or 69mm) will be determined by best fit based on an individual ginal exam.
Adherence to the device will be recorded by confirmation that the device remains insitu and has not been removed or expelled at review appointment (1 month, 3 months, 6 months)




Intervention code [1] 330023 0
Treatment: Drugs
Intervention code [2] 330024 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339976 0
The 1st primary outcome measure is treatment of genitourinary syndrome of menopause (GSM) (or vaginal atrophy) as shown by change in the Vaginal Maturation Index (VMI) from postmenopausal range to pre menopausal range. .During menopause, the ratio of the three vaginal epithelial cell types (parabasal, intermediate, and superficial) changes. The proportion of these vaginal cell types is categorized by the VMI. The VMI provides an objective assessment of vaginal hormone response and overall hormonal environment.
Timepoint [1] 339976 0
Baseline, 1 month post insertion, 3 months post insertion, 6 months post insertion (primary end point)
Primary outcome [2] 340377 0
The 2nd primary outcome measure is treatment of genitourinary syndrome of menopause (GSM) (or vaginal atrophy) as shown by change in vaginal pH from postmenopausal range to pre menopausal range.
Timepoint [2] 340377 0
Baseline, 1 month post insertion, 3 months post insertion, 6 months post insertion (primary end point)
Secondary outcome [1] 442139 0
Continued usage of the allocated pessary at 6-months
Timepoint [1] 442139 0
6-months post pessary insertion.
Secondary outcome [2] 442140 0
Luteinizing Hormone (LH)
Timepoint [2] 442140 0
Baseline, 1 month post insertion, 3 months post insertion, 6 months post insertion.
Secondary outcome [3] 442141 0
Patient reported improvement of prolapse and genitourinary syndrome of menopause symptoms with pessary treatment.
Timepoint [3] 442141 0
6 months post insertion.
Secondary outcome [4] 442142 0
Treatment related adverse effects (TRAE)
Timepoint [4] 442142 0
Baseline, 1 month post insertion, 3 months post insertion, 6 months post insertion.
Secondary outcome [5] 442827 0
Follicle Stimulating Hormone (FSH)
Timepoint [5] 442827 0
Baseline, 1 month post insertion, 3 months post insertion, 6 months post insertion.
Secondary outcome [6] 443903 0
Level of satisfaction after pessary treatment
Timepoint [6] 443903 0
6 months post insertion.
Secondary outcome [7] 443904 0
Estriol level
Timepoint [7] 443904 0
Baseline, 1 month post insertion, 3 months post insertion, 6 months post insertion.

Eligibility
Key inclusion criteria
Women who have/who are:
• At least 18 years old with symptomatic prolapse and estrogen deficiency
• Able to comprehend and complete study materials
• Able to provide informed consent to participate in the study
• POP-Q Stage II symptomatic pelvic organ prolapse from any single compartment or multi-compartment prolapse
• Willing to use vaginal pessary
• Willing and able to adhere to follow up visits.
• Endometrial thickness <4mm on pelvic ultrasound scan within 6 months of pessary recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have/who are:
• Unable to provide informed consent to participate.
• Presence of abnormal uterine or undiagnosed vaginal bleeding
• Contraindication to estrogen use:
o thromboembolic disease or coagulopathies
o History of uterine cancer
• Advanced pelvic organ prolapse (stage III or IV) per POP-Q definition
• Wide genital hiatus (> 4 finger breadth)
• Short vagina (<6cm)
• Prior hysterectomy
• Prior prolapse surgery
• Active vaginal infection
• Chronic vaginal fungal infections such as Candida
• Prior systemic or topical vaginal estrogen therapy in the 3 months before the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
4/05/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27490 0
Joan Kirner Women’s and Children’s Hospital - St Albans
Recruitment postcode(s) [1] 43599 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 317886 0
Commercial sector/Industry
Name [1] 317886 0
E-Leviate Pharma Ltd
Country [1] 317886 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Bespoke Clinical Research
Address
Country
Australia
Secondary sponsor category [1] 320223 0
None
Name [1] 320223 0
Address [1] 320223 0
Country [1] 320223 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316570 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316570 0
Ethics committee country [1] 316570 0
Australia
Date submitted for ethics approval [1] 316570 0
27/11/2024
Approval date [1] 316570 0
Ethics approval number [1] 316570 0

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

Contacts
Principal investigator
Name 138282 0
Dr Rebecca McDonald
Address 138282 0
Pelvic Floor Unit, Department of Obstetrics and Gynaecology, Sunshine Hospital, Western Health., 176 Furlong Road, St Albans,Melbourne, Australia 3021
Country 138282 0
Australia
Phone 138282 0
+61 03 8345 1333
Fax 138282 0
Email 138282 0
[email protected]
Contact person for public queries
Name 138283 0
Kerry O'Sullivan
Address 138283 0
Physiotherapy Unit, Western Health, 176 Furlong Road, St Albans,Melbourne, Australia 3021
Country 138283 0
Australia
Phone 138283 0
+61 0434 854 355
Fax 138283 0
Email 138283 0
[email protected]
Contact person for scientific queries
Name 138284 0
Rebecca McDonald
Address 138284 0
Pelvic Floor Unit, Department of Obstetrics and Gynaecology, Sunshine Hospital, Western Health., 176 Furlong Road, St Albans,Melbourne, Australia 3021
Country 138284 0
Australia
Phone 138284 0
+61 03 8345 1333
Fax 138284 0
Email 138284 0
[email protected]

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.