None listed
Conditions
Brief summary
This research project is testing a new treatment. The new treatment is a vaginal ring pessary that delivers estriol to treat both pelvic organ prolapse (POP) and genitourinary syndrome of menopause (GSM) at the same time. We hypothesise that, compared to the existing vaginal pessary and estrogen therapy in the market, the estriol integrated vaginal pessary is an effective treatment for symptomatic pelvic organ prolapse and genitourinary syndrome of menopause (GSM) without additional treatment side effects.
Interventions
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 co
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)
Sponsors
Bespoke Clinical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed