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

PDC Biotech GmbH4 sites in 2 countries24 target enrollmentNovember 2010

ConditionsDysmenorrhea

InterventionsPDC31

DrugsPDC31

Overview

Phase: Phase 1
Intervention: PDC31
Conditions: Dysmenorrhea
Sponsor: PDC Biotech GmbH
Enrollment: 24
Locations: 4
Primary Endpoint: Occurrence of Dose-Limiting Toxicity
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

PDC Biotech GmbH

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

PDC31

Intervention: PDC31

Outcomes

Primary Outcomes

Occurrence of Dose-Limiting Toxicity

Time Frame: Observed following PDC31 administration to 30 day follow-up

Secondary Outcomes

Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility(Observed immediately following PDC31 administration)