A Phase IIa study investigating the efficacy and safety of the c-Jun-N-Terminal Kinase (JNK) inhibitor PGL5001 versus placebo administered for up to 5 months with concomitant administration of depot medroxyprogesterone acetate (DMPA) for the treatment of peritoneal and/or ovarian endometriosis with an inflammatory component, prior to surgery. - JADE

PregLem S.A.0 sitesMay 9, 2012

Overview

No summary available.

Registry

who.int

Start Date

May 9, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

PregLem S.A.

•To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
•1\.The Subject must provide written informed consent prior to initiation of any study related procedures.
•2\.The Subject must be an adult woman of reproductive age, aged from 18 and above.
•3\.The Subject must have a BMI \= 18 kg/m2 and \= 40 kg/m2
•4\.The Subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis.
•5\.The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
•6\.The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.
•7\.The Subject must have a clinical breast examination without significant findings at the screening visit.
•8\.The Subject must have no clinically significant findings at Papanikolaou test (PAP) smear, performed within the past 12 months or at the screening visit.
•9\.The Subject must have access to a refrigerator where study drug can be properly stored.

•To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
•1\.The Subject is over 40 years old and has a FSH serum level during Day 2\-4 of her cycle \= 21\.5 mIU/ml.
•2\.The Subject has a positive pregnancy test at baseline or is breast\-feeding or planning a pregnancy during the course of the study.
•3\.The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
•4\.The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
•5\.The Subject has a history of or a current uterine, cervical, ovarian or breast cancer.
•6\.The Subject has undiagnosed abnormal genital bleeding.
•7\.The Subject has a history of or known current osteoporosis.
•8\.The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
•9\.The Subject has a chronic disease or conditions that could modify the absorption, distribution, metabolism, or excretion of the drug under investigation.