Dysmenorrhea
Conditions
Keywords
Open label, dose-finding Phase 1 study
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.
Interventions
DRUGPDC31
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.
Sponsors
PDC Biotech GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Dose-Limiting Toxicity | Observed following PDC31 administration to 30 day follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility | Observed immediately following PDC31 administration |
Countries
Austria, Germany
Outcome results
None listed