PGL2001 Proof of Concept Study in Symptomatic Endometriosis | NCT01631981

Studies
PGL2001 Proof of Concept Study in Symptomatic Endometriosis

NCT01631981

Sponsor

PregLem SA

Status

Completed

Last Update Posted

Jun 3, 2014Estimated

Enrollment

162Actual

Phase

Phase 2

Conditions

Endometriosis

Interventions

PGL2001 + Primolut-Nor 5
Placebo + Primolut-Nor 5

Countries

Hungary
Poland
Romania

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

Oct 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jun 28, 2012

First Posted Date

Jun 29, 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)

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 Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of 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

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PGL2001	Experimental	PGL2001 + NETA followed by NETA-only follow-up period	Drug: PGL2001 + Primolut-Nor 5
Placebo	Placebo Comparator	Placebo + NETA followed by NETA-only follow-up period	Drug: Placebo + Primolut-Nor 5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PGL2001 + Primolut-Nor 5	Drug	PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-menstrual pelvic pain.	Use of a Visual Analogue Scale (VAS).	Daily collection up to 16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent prior to initiation of any study related procedures.
Be a woman of reproductive age between 18 and 45 years inclusive.
Present with clinical signs suggestive of endometriosis.
Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.

Exclusion Criteria:

Be pregnant or currently lactating.
Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis.
Have had any surgical treatment for endometriosis within the last 12 months.
Have documented significant adenomyosis.
Have participated in another clinical trial within the 30 days prior to the screening visit.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Synexus Magyarország Kft.		Budapest		1036	Hungary
Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided