Clinical trial NCT01630252: PGL5001 Proof of Concept Study in Inflammatory Endometriosis
Official title: A Phase IIa Efficacy and Safety Study of PGL5001 Versus Placebo Administered for up to 5 Months With Concomitant Administration of Depot Medroxyprogesterone Acetate for the Treatment of Peritoneal and/or Ovarian Endometriosis With an Inflammatory Component.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: PregLem SA
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001 orally administered for up to 5 months with concomitant DMPA administration for the treatment of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the parts A2 and B are double-blind.

The target population will be women of reproductive age and suffering from newly diagnosed peritoneal and/or ovarian endometriosis.


Eligibility criteria: Inclusion Criteria:

* The Subject must provide written informed consent prior to initiation of any study related procedures.
* The Subject must be an adult woman of reproductive age, aged from 18 and above.
* 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.
* The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
* The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.

Exclusion Criteria:

* The Subject is over 40 years old and has a FSH serum level during Day 2-4 of her cycle ≥ 21.5 mIU/ml.
* The Subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study.
* The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
* The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
* The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
* The Subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than NSAID (e.g. GnRH agonist or antagonist, danazol, continuous oral combined oestroprogestogens).

Primary outcomes:
measure: Change from baseline to end of treatment in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions.
timeFrame: at week 8, week 20
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.
Study officials:
affiliation: PregLem SA
name: Elke Bestel, MD
role: STUDY_DIRECTOR
References: