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
Completed
- Conditions
- NApharmacokinetics of oxybutynin and gonadorelin1001027310004994
- Registration Number
- NL-OMON42626
- Lead Sponsor
- iGalli BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK parameters (Cmax, tmax, t1/2el, AUC) of oxybutynin and gonadorelin</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety endpoint such as<br /><br>((S)AEs).<br /><br>Concomitant medication<br /><br>Vital signs<br /><br>Vaginal examination</p><br>