A phase I, mono-center, randomized, placebo and comparator controlled, single blind, rising dose, clinical study to determine single dose pharmacokinetics, pharmacodynamics, safety and tolerability of four doses of FSH-GEX* according to adaptive design (25, 75, 150 and 300 IU) administered subcutaneously in healthy pituitary-suppressed female volunteers
Completed
- Conditions
- Infertility10013356
- Registration Number
- NL-OMON36196
- Lead Sponsor
- Glycotope GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Healthy female subjects
Exclusion Criteria
Clinical significant abnormalities at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To assess the safety and (local) tolerability of test compound following<br /><br>single rising dose administration by subcutaneous injection<br /><br>- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of<br /><br>test compound following single rising dose administration<br /><br>by subcutaneous injection.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the pharmacodynamic effect of test compound following single<br /><br>rising dose administration by subcutaneous injection as<br /><br>determined by Estradiol (E2) and inhibin B concentrations and ovarian<br /><br>follicle size, as determined by transvaginal ultrasonography (TVUS)</p><br>