Status:
COMPLETED
Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea
Lead Sponsor:
PDC Biotech GmbH
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01250587
Start Date
November 1 2010
End Date
June 1 2012
Last Update
September 24 2012
Active Locations (4)
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1
Innsbruck Medical University
Innsbruck, Austria
2
Medical University of Vienna
Vienna, Austria
3
University Hospital Hamburg-Eppendorf
Hamburg, Germany
4
University of Mainz
Mainz, Germany