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Completed

NCT Number: NCT01250587

Dose-Finding Study 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.

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Innsbruck Medical University, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDC31

Drug

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.

Primary outcomes

  1. Occurrence of Dose-Limiting Toxicity

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

Secondary outcomes

  1. Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility

    Time frame: Observed immediately following PDC31 administration

Sponsors and collaborators

Lead sponsor

PDC Biotech GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2010
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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