Endometriosis
Conditions
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.
Interventions
DRUGPGL5001
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
DRUGPlacebo
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
Sponsors
PregLem SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | at week 8, week 20 |
Countries
Poland
Outcome results
None listed