Back to resultsDose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PDC31
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring Open label, dose-finding Phase 1 study
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
Sites / Locations
- Innsbruck Medical University
- Medical University of Vienna
- University Hospital Hamburg-Eppendorf
- University of Mainz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PDC31
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of Dose-Limiting Toxicity
Secondary Outcome Measures
Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01250587
Brief Title
Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea
Official Title
A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PDC31 in Patients With Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PDC Biotech GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
Open label, dose-finding Phase 1 study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDC31
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PDC31
Intervention Description
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 Outcome Measure Information:
Title
Occurrence of Dose-Limiting Toxicity
Time Frame
Observed following PDC31 administration to 30 day follow-up
Secondary Outcome Measure Information:
Title
Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility
Time Frame
Observed immediately following PDC31 administration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Innsbruck Medical University
City
Innsbruck
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
University Hospital Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
University of Mainz
City
Mainz
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25164021
Citation
Bottcher B, Laterza RM, Wildt L, Seufert RJ, Buhling KJ, Singer CF, Hill W, Griffin P, Jilma B, Schulz M, Smith RP. A first-in-human study of PDC31 (prostaglandin F2alpha receptor inhibitor) in primary dysmenorrhea. Hum Reprod. 2014 Nov;29(11):2465-73. doi: 10.1093/humrep/deu205. Epub 2014 Aug 27.
Results Reference
derived
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Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea
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