An open-label, two-way cross-over, randomized study to assess the pharmacokinetics and safety/tolerability of intra-vaginal delivery of gonadorelin and oxybutynin in healthy female volunteers

An open-label, two-way cross-over, randomized study to assess the pharmacokinetics and safety/tolerability of intra-vaginal delivery of gonadorelin and oxybutynin in healthy female volunteers - Pharmacokinetics of intravaginal drug delivery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42626

Enrollment

Registered

2015-09-16

Start date

2015-11-06

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NA pharmacokinetics of oxybutynin and gonadorelin

Interventions

Intravaginal administration of a single dose of oxybutynin (1 mg) and gonadoreline (1 mg) on 2 different occasions

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Healthy female subjects aged between 18 and 40 years (inclusive) 2. Body mass index between 18-32 kg*m2 (inclusive); 3. Using oral contraceptives of second generation containing ethinylestradiol and progesterone derivate.

Exclusion criteria

Exclusion criteria: 1. Clinically significant abnormalities in laboratory test, vital signs and ECG 2. Being a virgin. 3. History of sexual abuse/violence. 4. Being pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
PK parameters (Cmax, tmax, t1/2el, AUC) of oxybutynin and gonadorelin	—

Secondary

Measure	Time frame
Safety endpoint such as ((S)AEs). Concomitant medication Vital signs Vaginal examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)