Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

September 20, 2012 updated by: PDC Biotech GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Innsbruck Medical University
      • Vienna, Austria
        • Medical University of Vienna
  • Germany
      • Hamburg, Germany
        • University Hospital Hamburg-Eppendorf
      • Mainz, Germany
        • University of Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Dose-Limiting Toxicity
Time Frame: Observed following PDC31 administration to 30 day follow-up
Observed following PDC31 administration to 30 day follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility
Time Frame: Observed immediately following PDC31 administration
Observed immediately following PDC31 administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PDC Biotech GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (ESTIMATE)

December 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDC-3111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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