Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

PDC Biotech

Status and phase

Completed

Phase 1

Conditions

Dysmenorrhea

Treatments

Drug: PDC31

Study type

Interventional

Funder types

Industry

Identifiers

NCT01250587

PDC-3111

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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