Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01250587
Other study ID # PDC-3111
Secondary ID
Status Completed
Phase Phase 1
First received November 29, 2010
Last updated September 20, 2012
Start date November 2010
Est. completion date June 2012

Study information

Verified date September 2012
Source PDC Biotech GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PDC31
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.

Locations

Country Name City State
Austria Innsbruck Medical University Innsbruck
Austria Medical University of Vienna Vienna
Germany University Hospital Hamburg-Eppendorf Hamburg
Germany University of Mainz Mainz

Sponsors (1)

Lead Sponsor Collaborator
PDC Biotech GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of Dose-Limiting Toxicity Observed following PDC31 administration to 30 day follow-up Yes
Secondary Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility Observed immediately following PDC31 administration No
See also
  Status Clinical Trial Phase
Completed NCT04607382 - Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT00769964 - VA111913 TS: First in Human Study Phase 1
Completed NCT00746096 - Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea Phase 3
Completed NCT00104546 - Vitamin K Injections for the Treatment of Painful Menstruation Phase 1
Completed NCT06011928 - MOPEXE and RE in Treating Dysmenorrhea N/A
Not yet recruiting NCT06398990 - The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea N/A
Recruiting NCT02031523 - Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis Phase 4
Completed NCT01449305 - Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea N/A
Completed NCT00995917 - A Pilot Study of Acupoint Injection for Primary Dysmenorrhea N/A
Completed NCT02910167 - Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Not yet recruiting NCT05461846 - Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Not yet recruiting NCT03697746 - Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea N/A
Recruiting NCT03394547 - Pulsed Electromagnetic Field Treatment for Painful Periods N/A
Recruiting NCT06294743 - Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea Early Phase 1
Active, not recruiting NCT01738204 - The Women's Health Study: From Adolescence to Adulthood
Completed NCT01462370 - Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1) Phase 3
Completed NCT00951561 - A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen N/A
Completed NCT03972917 - Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy