EndometriosisPhase 2JADENCT01630252
PGL5001 Proof of Concept Study in Inflammatory Endometriosis
A Phase 2 study testing PGL5001 in people with Endometriosis, run by PregLem SA at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- PGL5001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Poland1 site
Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.
Bialystok, 15-224
About this study
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.
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.
- Conditions
- Endometriosis
- Being tested
- PGL5001, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGL5001Drug
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
PlaceboDrug
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001Drug
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
PlaceboDrug
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
PGL5001Drug
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
| Study group | Role | What they receive |
|---|---|---|
| Part A2 - Active Treatment arm | Active comparator | PGL5001 for 8 weeks + one DMPA injection Receives: Drug: PGL5001 |
| Part A2 - Placebo Treatment arm | Placebo comparator | PGL5001 matching placebo for 8 weeks + one DMPA injection Receives: Drug: Placebo |
| Part B - Active treatment arm | Active comparator | PGL5001 for 20 weeks + two DMPA injections Receives: Drug: PGL5001 |
| Part B - Placebo Treatment arm | Placebo comparator | PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections Receives: Drug: Placebo |
| Part A1 - Active Treatment arm | Experimental | PGL5001 for 8 weeks + one unique DMPA 150 mg injection Receives: Drug: PGL5001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week 8, week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elke Bestel, MD, Study director, PregLem SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630252
- Sponsor's protocol ID
- PGL11-021
- Acronym
- JADE
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2012
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01630252
- Acronym / sponsor ID
- JADE / PGL11-021
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A2 - Active Treatment arm | Active comparator | Drug: PGL5001PGL5001 for 8 weeks + one DMPA injection |
| Part A2 - Placebo Treatment arm | Placebo comparator | Drug: PlaceboPGL5001 matching placebo for 8 weeks + one DMPA injection |
| Part B - Active treatment arm | Active comparator | Drug: PGL5001PGL5001 for 20 weeks + two DMPA injections |
| Part B - Placebo Treatment arm | Placebo comparator | Drug: PlaceboPGL5001 matching placebo for 20 weeks + two DMPA 150mg injections |
| Part A1 - Active Treatment arm | Experimental | Drug: PGL5001PGL5001 for 8 weeks + one unique DMPA 150 mg injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PGL5001PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection | Drug | Part A2 - Active Treatment arm |
| PlaceboPGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection | Drug | Part A2 - Placebo Treatment arm |
| PGL5001PGL5001 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 | Part B - Active treatment arm |
| PlaceboPGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection | Drug | Part B - Placebo Treatment arm |
| PGL5001PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection | Drug | Part A1 - Active Treatment arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elke Bestel, MD study director
PregLem SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PGL5001 in people with Endometriosis, run by PregLem SA at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.