PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PregLem SA
ClinicalTrials.gov Identifier:
NCT01630252
First received: June 26, 2012
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: PGL5001
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by PregLem SA:

Primary Outcome Measures:
  • 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. [ Time Frame: at week 8, week 20 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A2 - Active Treatment arm
PGL5001 for 8 weeks + one DMPA injection
Drug: PGL5001
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
Placebo Comparator: Part A2 - Placebo Treatment arm
PGL5001 matching placebo for 8 weeks + one DMPA injection
Drug: Placebo
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
Active Comparator: Part B - Active treatment arm
PGL5001 for 20 weeks + two DMPA injections
Drug: PGL5001
PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
Placebo Comparator: Part B - Placebo Treatment arm
PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections
Drug: Placebo
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
Experimental: Part A1 - Active Treatment arm
PGL5001 for 8 weeks + one unique DMPA 150 mg injection
Drug: PGL5001
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630252

Locations
Poland
Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.
Bialystok, Poland, 15-224
Sponsors and Collaborators
PregLem SA
Investigators
Study Director: Elke Bestel, MD PregLem SA
  More Information

No publications provided

Responsible Party: PregLem SA
ClinicalTrials.gov Identifier: NCT01630252     History of Changes
Other Study ID Numbers: PGL11-021
Study First Received: June 26, 2012
Last Updated: June 2, 2014
Health Authority: Poland: Ministry of Health
Poland: Ethics Committee

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014