PGL5001 Proof of Concept Study in Inflammatory Endometriosis | NCT01630252

Studies
PGL5001 Proof of Concept Study in Inflammatory Endometriosis

NCT01630252

Sponsor

PregLem SA

Status

Completed

Last Update Posted

Jun 3, 2014Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Endometriosis

Interventions

PGL5001
Placebo
PGL5001
Placebo
PGL5001

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jun 26, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2014

Last Update Posted Date

Jun 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A2 - Active Treatment arm	Active Comparator	PGL5001 for 8 weeks + one DMPA injection	Drug: PGL5001
Part A2 - Placebo Treatment arm	Placebo Comparator	PGL5001 matching placebo for 8 weeks + one DMPA injection	Drug: Placebo
Part B - Active treatment arm	Active Comparator	PGL5001 for 20 weeks + two DMPA injections	Drug: PGL5001
Part B - Placebo Treatment arm	Placebo Comparator	PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections	Drug: Placebo
Part A1 - Active Treatment arm	Experimental	PGL5001 for 8 weeks + one unique DMPA 150 mg injection	Drug: PGL5001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PGL5001	Drug	PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection	Part A2 - Active Treatment arm

Measure	Description	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

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases