PGL5001 Proof of Concept Study in Inflammatory Endometriosis

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

October 31, 2013

Conditions
Endometriosis
Interventions
DRUG

PGL5001

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

DRUG

Placebo

PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection

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

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

DRUG

PGL5001

PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection

Trial Locations (1)

15-224

Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o., Bialystok

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PregLem SA

INDUSTRY