Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

NCT01250587 | Completed Phase 1 DMC

• 1 other identifier: PDC-3111
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 4

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.

Conditions

Dysmenorrhea

Keywords

Open label; dose-finding Phase 1 study

Outcome Measures

Primary Outcomes (1)

• Occurrence of Dose-Limiting Toxicity

  Observed following PDC31 administration to 30 day follow-up

Secondary Outcomes (1)

• Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility

  Observed immediately following PDC31 administration

Study Arms (1)

PDC31

EXPERIMENTAL

Drug: PDC31

Interventions

PDC31 DRUG

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.

PDC31

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PDC Biotech GmbH: lead

Study Sites (4)

Innsbruck Medical University

Innsbruck, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

University Hospital Hamburg-Eppendorf

Hamburg, Germany

Location

University of Mainz

Mainz, Germany

Location

Related Publications (1)

• 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.

  PMID: 25164021 DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

AU (2); DE (2)