urinary urge incontinence
Conditions
Interventions
Trade Name: Oxybutynin Hydrochloride
Pharmaceutical Form: Solution for infusion in administration system
Sponsors
Ligalli BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 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. 11. Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 21 days prior to dosing. 12. Use of alcohol during the 24 hours prior to Day 1 of the study. 13. Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject. 14. Presence of significant postvoid residual urine determined as >100 ml estimated by ultrasound immediately postvoiding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the influence of intravaginal oxybutynin administration by the MedRing on bladder filling phase in OAB patients;Secondary Objective: To assess the safety and tolerability of the intra-vaginal delivery of oxybutynin via the MedRing in OAB patients;Primary end point(s): The primary endpoints, related to PD will be evaluated based on the subject’s response on the sensation meter. The sensation meter has been studied before for this purpose and the endpoints are based on these studies [9,10,11]. This study will assess the plasma level of oxybutynin at the various stages of urge sensations to evaluate the possible direct effect of local (vaginal) administration of oxybutynin, before the maximum plasma level is reached. ;Timepoint(s) of evaluation of this end point: Cycle 3: Direct effect. oStarts drinking protocol oactivation ring 10 minutes before expected bladder sensation (from Cycle 1 and2). oAt 50% / 75% and 100% of full bladder sensation – PK blood sample taken. oFill questionnaire anticholinergic side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will focus on safety and are: • all AEs with a focus on treatment-emergent and serious AEs, as a general safety endpoint. • Anticholinergic side effects (dry mouth, headache, abdominal pain) to assess the expected anticholinergic side effects related to the use oxybutynin. • Local effects (irritation) to assess the local tolerance of the MedRing in combination with vaginal delivery of oxybutynin. • Physical examination (vital signs and in speculum examination as a general safety endpoint. ;Timepoint(s) of evaluation of this end point: CYcle 3 and 4 | — |
Countries
Belgium
Contacts
Public Contactregina Hart
Ligalli BV
Outcome results
None listed