Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PDC Biotech GmbH

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