EndometriosisPhase 2AMBERNCT01631981
PGL2001 Proof of Concept Study in Symptomatic Endometriosis
A Phase 2 study testing PGL2001 + Primolut-Nor 5 in people with Endometriosis, run by PregLem SA at 20 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- PGL2001 + Primolut-Nor 5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Jun 2012to May 2014
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Poland10 sites
Medica Pro Familia Sp. z o.o. S.K.A. - Oddział Katowie
Katowice, 40-954
Medeor Plus Szpital Wielospecjalistyczny
Lodz, 91-308
Klinka Ginekologii Operacyjnej, Instytut-Centrum Zdrowia Matki Polki
Lodz, 93-338
Specjalistyczny Gabinet Ginekologiczno-Położniczy
Lublin, 20-496
Klinika Endokrynologii I Nieplodnosci Rozrodu, Ginekologiczno Polozniczy Szpital UM
Poznan, 60-535
Lubelskie Centrum Diagnostyczne
Świdnik, 21040
VitroLive Sp. Z o.o
Szczecin, 71-074
NZOZ Lecznica Medea
Warsaw, 01-826
Private practice
Warsaw, 02-201
Centralny Szpital Kliniczny MSWiA, Klinika Połoznictwa, Chorob Kobiecych i Ginekologii Onkologicznej
Warsaw, 02-507
Hungary5 sites
Synexus Magyarország Kft.
Budapest, 1036
Semmelweis Egyetem II. Szülészeti és Nőgyógyászati Klinika
Budapest, 1082
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum Szuleszeti es Nogyogyaszati Klinika
Debrecen, 4012
Pécsi Tudományegyetem Klinikai Központ Szülészeti és Nőgyógyászati Klinika
Pécs, 7624
Szegedi Tudományegyetem Szent-Györgyi Albert Klinkai Központ Szülészeti és Nőgyógyászati Klinika
Szeged, 6725
Romania5 sites
Euromedica Hospital SA
Baia Mare, 430032
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL
Brasov, 500283
Genesys Fertility Center SRL
Bucharest, 011475
Centrul Medical Euromed SRL
Bucharest, 020762
Spitalul Clinic "Nicolae Malaxa"
Bucharest, 022441
About this study
Official title: A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis
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.
- Conditions
- Endometriosis
- Being tested
- PGL2001 + Primolut-Nor 5, Placebo + Primolut-Nor 5
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGL2001 + Primolut-Nor 5Drug
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.
Placebo + Primolut-Nor 5Drug
Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks.
Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| PGL2001 | Experimental | PGL2001 + NETA followed by NETA-only follow-up period Receives: Drug: PGL2001 + Primolut-Nor 5 |
| Placebo | Placebo comparator | Placebo + NETA followed by NETA-only follow-up period Receives: Drug: Placebo + Primolut-Nor 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-menstrual pelvic pain.
Use of a Visual Analogue Scale (VAS).
Measured: Daily collection up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionMay 2014
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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- PregLem SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631981
- Sponsor's protocol ID
- PGL11-007
- Acronym
- AMBER
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2012
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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 II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis
- ClinicalTrials.gov ID
- NCT01631981
- Acronym / sponsor ID
- AMBER / PGL11-007
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- PregLem SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGL2001 | Experimental | Drug: PGL2001 + Primolut-Nor 5PGL2001 + NETA followed by NETA-only follow-up period |
| Placebo | Placebo comparator | Drug: Placebo + Primolut-Nor 5Placebo + NETA followed by NETA-only follow-up period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PGL2001 + Primolut-Nor 5PGL2001(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. | Drug | PGL2001 |
| Placebo + Primolut-Nor 5Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks. Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up. | Drug | Placebo |
Primary outcome
Non-menstrual pelvic pain.
Time frame: Daily collection up to 16 weeks
Use of a Visual Analogue Scale (VAS).
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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PGL2001 + Primolut-Nor 5 in people with Endometriosis, run by PregLem SA at 20 sites in 3 countries.
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 4 inclusion and 5 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 20 sites in Poland, Hungary, Romania. 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?
Non-menstrual pelvic pain. (time frame: Daily collection up to 16 weeks). 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.