- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01630252
PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)
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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Bialystok, Polen, 15-224
- Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Part A2 - Active Treatment arm
PGL5001 for 8 weeks + one DMPA injection
|
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
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 komparator: Part A2 - Placebo Treatment arm
PGL5001 matching placebo for 8 weeks + one DMPA injection
|
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
Aktiv komparator: Part B - Active treatment arm
PGL5001 for 20 weeks + two DMPA injections
|
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
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 komparator: Part B - Placebo Treatment arm
PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections
|
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
Eksperimentel: Part A1 - Active Treatment arm
PGL5001 for 8 weeks + one unique DMPA 150 mg injection
|
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: at week 8, week 20
|
at week 8, week 20
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Elke Bestel, MD, PregLem SA
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PGL11-021
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