PGL5001 Proof of Concept Study in Inflammatory Endometriosis - Full Text View

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:

MedlinePlus related topics: Endometriosis

Drug Information available for: Medroxyprogesterone acetate

U.S. FDA Resources

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 ]

Estimated Enrollment:	24
Study Start Date:	June 2012
Estimated Study Completion Date:	October 2013
Estimated 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

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

Contacts

Contact: Elke Bestel, MD

medical@preglem.com

Locations

Poland
Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.	Recruiting
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:	July 3, 2012
Health Authority:	Poland: Ministry of Health Poland: Ethics Committee

Additional relevant MeSH terms:

Endometriosis
Genital Diseases, Female
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013

PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)