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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014