Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PDC Biotech GmbH
ClinicalTrials.gov Identifier:
NCT01250587
First received: November 29, 2010
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Dysmenorrhea
Drug: PDC31
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PDC31 in Patients With Primary Dysmenorrhea

Further study details as provided by PDC Biotech GmbH:

Primary Outcome Measures:
  • Occurrence of Dose-Limiting Toxicity [ Time Frame: Observed following PDC31 administration to 30 day follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility [ Time Frame: Observed immediately following PDC31 administration ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDC31 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250587

Locations
Austria
Innsbruck Medical University
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany
University of Mainz
Mainz, Germany
Sponsors and Collaborators
PDC Biotech GmbH
  More Information

No publications provided

Responsible Party: PDC Biotech GmbH
ClinicalTrials.gov Identifier: NCT01250587     History of Changes
Other Study ID Numbers: PDC-3111
Study First Received: November 29, 2010
Last Updated: September 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by PDC Biotech GmbH:
Open label
dose-finding Phase 1 study

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014