Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

Phase 1

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: PDC31

• Registration Number: NCT01250587
• Lead Sponsor: PDC Biotech GmbH

Brief 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Otherwise healthy females with a history of primary dysmenorrhea
• Using effective birth control excluding intrauterine contraceptive device (IUCD)
• Must be 18 years of age or older
• Must give written informed consent to participate in this study

Exclusion Criteria

• Patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study
• Patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis
• Patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study
• Patients who are breastfeeding
• Patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the Investigator at screening
• Patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study
• Patients who have been exposure to any investigational drug within 4 weeks prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDC31	PDC31	-

Primary Outcome Measures

Name	Time	Method
Occurrence of Dose-Limiting Toxicity	Observed following PDC31 administration to 30 day follow-up

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility	Observed immediately following PDC31 administration

Trial Locations

Locations (4)

Innsbruck Medical University; 🇦🇹 Innsbruck, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

University of Mainz; 🇩🇪 Mainz, Germany

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany