Dysmenorrhea Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Innsbruck Medical University | Innsbruck | |
Austria | Medical University of Vienna | Vienna | |
Germany | University Hospital Hamburg-Eppendorf | Hamburg | |
Germany | University of Mainz | Mainz |
Lead Sponsor | Collaborator |
---|---|
PDC Biotech GmbH |
Austria, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of Dose-Limiting Toxicity | Observed following PDC31 administration to 30 day follow-up | Yes | |
Secondary | Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility | Observed immediately following PDC31 administration | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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