INFLUENCE OF OXYBUTYNIN - MEDRING LIGALLI ON OVERACTIVE BLADDER SYMPTOMS IN WOMEN - MedRing-04

igalli BV0 sites9 target enrollmentAugust 18, 2022

Overview

No summary available.

Registry

who.int

Start Date

August 18, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

igalli BV

•1\.Willing to give written informed consent and willing and able to comply with the study protocol.
•2\.Female subjects aged between 18 and 70 years (inclusive)
•3\.Women diagnosed with OAB according to the definition of the International Continence Society (ICS), and responding with a score 3 or higher on question 5a of the ICIQ questionnaire do you have to rush to the toilet to urinate”?
•4\.Subject is in good general health, according to the investigator’s judgement based on medical history, vital signs, physical examination, electrocardiogram (ECG), and laboratory tests performed.
•5\.Body mass index between 18\-32 kg·m2 (inclusive) and with a minimum body weight of 50 kg at screening.
•6\.Ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions.
•7\.Using adequate contraception (if applicable).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\.Presence of virginity.
•2\.History of sexual abuse/violence.
•3\.Menstrual bleeding or withdrawal bleeding from oral contraceptive pill expected to occur during conduction of the study.
•4\.Positive urinary pregnancy test at screening or at baseline and/or lactating.
•5\.Having given birth vaginally or by caesarean section 6 months prior to screening
•6\.Having had sexual intercourse or objects inserted vaginally that could potentially lacerate or damage the vaginal wall 24 hours prior to dosing.
•7\.Medical history of intra\- and/or transvaginal operations that in the opinion of the investigator may interfere with placement or stability of the MedRing or absorption of oxybutynin.
•8\.Any known significant allergic reactions (urticaria or anaphylaxis) against oxybutynin, or multiple drug allergies (non\-active hay fever is acceptable), or known hypersensitivity to components of the MedRing (polypropylene, styrene triblock copolymer, coloring agents, coating, glue).
•9\.Participation in any marketed or investigational drug or device study within 3 months or 5 half\-lives (whichever is longer) prior to dosing.
•10\.Botox administration in the pelvic area less than 12 months ago.