Peritoneal and/or ovarian endometriosis with an inflammatory component. MedDRA version: 14.1 Level: LLT Classification code 10014784 Term: Endometriosis of ovary System Organ Class: 100000004872 MedDRA version: 14.1 Level: LLT Classification code 10014785 Term: Endometriosis of pelvic peritoneum System Organ Class: 100000004872
Conditions
Interventions
Product Name: PGL5001
Pharmaceutical Form: Capsule
INN or Proposed INN: bentamapimod
Current Sponsor code: PGL5001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
PregLem S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 10. The Subject must be able and willing to comply with the requirements of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. 10. 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, danazole, continuous oral combined oestroprogestogens). 11. The Subject used oral contraceptives and/or progestins for contraception in the past 3 months before the first diagnostic laparoscopy. 12. The Subject has current use of or is likely to require treatment with drugs that are not permitted during the study such as: a. Hormonal treatments b. GnRH-agonists/ antagonists c. Danazole d. Drugs metabolized through CYP2C8 13. The Subject has abnormal hepatic function at study entry, defined as AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re-test is allowed. 14. The Subject has contraindications to the use of DMPA such as (please refer to the SmPC): a. active thrombophlebitis, current or history of thromboembolism or cerebrovascular disease b. confirmed or suspected hormone-dependent malignancy of the breast or the genital organs c. known sensitivity to medroxyprogesterone acetate or any ingredient of the vehicle (see list of ingredients in the SmPC). 15. The Subject is unwilling to refrain from sun exposure during the treatment period and for 5 days post last dose. 16. The Subject has abnormal baseline findings or any other medical condition(s), which in the opinion of the investigator, may jeopardise the subject’s safety or decrease the chance of obtaining reliable data. 17. The Subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse. 18. The Subject has psychiatric disturbance or is otherwise unlikely to follow the study procedures. 19. The Subject has participated in another clinical trial within the 30 days prior to the first screening visit. 20. The Subject has an allergy to any of the ingredients of the PGL5001 capsule (see list of ingredients in the investigator’s brochure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There are no identified primary/main objective as compared to the other objectives in the study, hence the objectives are all listed in the secondary objectives below. ;Secondary Objective: EXPLORATORY EFFICACY OBJECTIVES:•To explore efficacy of PGL5001 with concomitant DMPA administration versus placebo with concomitant DMPA administration in: reducing endometriosis red lesions (and/or inflammatory lesions),reducing non-active endometriosis black lesions,reducing endometriosis associated-adhesions,improving endometriosis-related symptoms such as pain;•To evaluate the pharmacodynamics (PD) of PGL5001, establishing the relationship between JNK activity and endometriosis progression by assessing the level of different markers, especially inflammatory markers in the peritoneal fluid, blood and tissue samples (eutopic and ectopic endometrium). For PHARMACOKINETIC OBJECTIVES and SAFETY OBJECTIVES please refer to study protocol, section 2.2 and 2.3.;Primary end point(s): There are no identified primary endpoint in the study. All endpoints are listed in secondary endpoints below.;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): EXPLORATORY EFFICACY ENDPOINTS • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions. • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the number and percentage of black lesions, based on total number of red and black lesions. • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the number of white lesions. • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the surface area (mm2) of red lesions. • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the surface area (mm2) of black lesions. • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the surface area (mm2) of white lesions. • Change from baseline to end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) in the presence of endometriosis-associated adhesions. • Mean score at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) for the Surgeon’s Impression of Laparoscopic Change scale. • Mean score at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) for the Clinical Global Impression of Improvement scale. • Percentage of patients at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) with a confirmed improvement according to the scale for Surgeon’s Impression of Laparoscopic Change. • Percentage of patients at end of treatment (Week 8 visit for Parts A1 and A2 or Week 20 visit for Part B) with a confirmed improvement according to the scale for Clinical Global Impression of Improvement. • Change from baseline to Week 4 and Week 8 | — |
Countries
Poland
Contacts
Public ContactGeneral Information desk
PregLem SA
Outcome results
None listed