Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

Phase 1 Completed 24 enrolled PDC Biotech GmbH

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2010-11
Primary completion: 2012-06
Completion: 2012-06

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PDC31	Unknown	0.01 mg/kg	Intravenous
Subject	PDC31	Unknown	0.05 mg/kg	Intravenous
Subject	PDC31	Unknown	0.15 mg/kg	Intravenous
Subject	PDC31	Unknown	0.3 mg/kg	Intravenous
Subject	PDC31	Unknown	0.5 mg/kg	Intravenous
Subject	PDC31	Unknown	1 mg/kg	Intravenous

Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

Summary

Timeline

Publications

Drugs

Indications