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: Infertility; 10013356

• Registration Number: NL-OMON36196
• Lead Sponsor: Glycotope GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

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>