Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250587
• Other study ID #: PDC-3111
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2010
• Last updated: September 20, 2012
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: PDC Biotech GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

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.

Locations

Country	Name	City	State
Austria	Innsbruck Medical University	Innsbruck
Austria	Medical University of Vienna	Vienna
Germany	University Hospital Hamburg-Eppendorf	Hamburg
Germany	University of Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
PDC Biotech GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Dose-Limiting Toxicity		Observed following PDC31 administration to 30 day follow-up	Yes
Secondary	Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility		Observed immediately following PDC31 administration	No