NCT01250587

Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PDC31 in Patients With Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PDC Biotech GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.

Detailed description

This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	PDC31	This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-12-01
• Last updated: 2012-09-24

Locations

4 sites across 2 countries: Austria, Germany