Clinical trial NCT01250587: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dysmenorrhea
Keywords: Open label
dose-finding Phase 1 study
Lead sponsor: PDC Biotech GmbH
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Occurrence of Dose-Limiting Toxicity
timeFrame: Observed following PDC31 administration to 30 day follow-up
Secondary outcomes:
measure: Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility
timeFrame: Observed immediately following PDC31 administration
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Mainz
country: Germany
facility: University of Mainz
Study officials:
References:
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.