EndometriosisPhase 2PLEASENCT01329796
Pertubation With Lignocaine in Endometriosis
A Phase 2 study testing Lignocaine and Ringers Solution in people with Endometriosis and Dysmenorrhea, run by Isifer AB at 3 sites in Sweden.
Trial summary
Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Endometriosis, Dysmenorrhea
- What is being tested?
- Lignocaine and Ringers Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesSweden
- Study dates
- Mar 2007to Mar 2010
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years
- endometriosis verified by laparoscopy
- dysmenorrhea or pelvic pain defined as a pain-score of >50 mm (VAS)
- normal Fallopian tubes
- regular menstrual cycles 21-35 days
- treatment with oral contraceptives (OC) ongoing > 1 month and continued during the trial
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- previous hormonal treatment discontinued > 1 month (OC, gestagens) and > 6 months (GnRH)
- no wish for pregnancy during the study
- normal Pap-smear
- negative Chlamydia-test
- negative pregnancy-test
- informed consent given and signed
Who cannot join
- Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease
- hyperreactivity to local anesthesia
- fibroids > 2 cm
- ongoing treatment with GnRH-analog
- ongoing continuous treatment with high dose gestagens
- pregnancy
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- peritubal adhesions
- occluded Fallopian tubes
- inability to understand information or comply with the study procedures
- participation in a clinical study within one year before the present study
- any disease or laboratory finding considered of importance by the investigator not to include the patient
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Läkargruppen Victoria Söderhallarna 120
Stockholm, Stockholm County, 118 72
Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
Stockholm, Stockholm County, 141 86
Department of Gynaecology and Obstetrics Danderyd Hospital
Stockholm, Stockholm County, 182 88
About this study
Official title: Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study
Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.
- Conditions
- Endometriosis, Dysmenorrhea
- Being tested
- Lignocaine, Ringers Solution
- Keywords
- dysmenorrhea,, pelvic pain, dyspareunia, endometriosis
- Medical subject headings
- Endometriosis, Dysmenorrhea, Pelvic Pain, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
Also called Lidocaine
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Ringers SolutionDrug
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pertubation with Endole® (lignocaine) | Experimental | Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles. Receives: Drug: Lignocaine |
| Placebo | Placebo comparator | Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles. Receives: Drug: Ringers Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
The pain-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatments=baseline for evaluation) and thereafter during 2nd, 3rd, 4 th, 7th, 10th and 13th menstrual periods.
Measured: After three pertubations
Secondary outcomes (1)
Quality of life-questionnaire (validated), EHP-30
The Quality of life-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatment=baseline for evaluation) and thereafter during 7th and 13th menstrual period.
Measured: At the 7th menstruation i.e. after approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isifer AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Region Stockholm
- Investigators
- Karin Wickström, MD, Principal investigator, Danderyd Hospital, SE-182 88 Stockholm, SwedenGreta Edelstam, MD, Study director, Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329796
- Sponsor's protocol ID
- ISI-06-01
- Acronym
- PLEASE
- Status last verified
- Apr 2011
- First submitted
- 4 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
PubMed 28844356Wickstrom K, Spira J, Edelstam G. Serum concentration of lignocaine after pertubation: an observational study. Drugs R D. 2013 Sep;13(3):235-9. doi: 10.1007/s40268-013-0022-8.
PubMed 23921822Wickstrom K, Bruse C, Sjosten A, Spira J, Edelstam G. Pertubation with lignocaine as a new treatment of dysmenorrhea due to endometriosis: a randomized controlled trial. Hum Reprod. 2012 Mar;27(3):695-701. doi: 10.1093/humrep/der434. Epub 2012 Jan 9.
PubMed 22232129
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study
- ClinicalTrials.gov ID
- NCT01329796
- Acronym / sponsor ID
- PLEASE / ISI-06-01
- Conditions
- Endometriosis, Dysmenorrhea
- Keywords
- dysmenorrhea,, pelvic pain, dyspareunia, endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Isifer ABIndustry (pharma, biotech, devices)
- Collaborators
- Region Stockholm
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Apr 2011 (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.
Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.
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 |
|---|---|---|
| Pertubation with Endole® (lignocaine) | Experimental | Drug: LignocaineThree treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles. |
| Placebo | Placebo comparator | Drug: Ringers SolutionPertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 20 years
- endometriosis verified by laparoscopy
- dysmenorrhea or pelvic pain defined as a pain-score of >50 mm (VAS)
- normal Fallopian tubes
- regular menstrual cycles 21-35 days
Key exclusion criteria (11 listed)
- Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease
- hyperreactivity to local anesthesia
- fibroids > 2 cm
- ongoing treatment with GnRH-analog
- ongoing continuous treatment with high dose gestagens
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 |
|---|---|---|
| LignocaineAlso: LidocaineIntrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles. | Drug | Pertubation with Endole® (lignocaine) |
| Ringers SolutionIntrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles. | Drug | Placebo |
Primary outcome
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
Time frame: After three pertubations
The pain-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatments=baseline for evaluation) and thereafter during 2nd, 3rd, 4 th, 7th, 10th and 13th menstrual periods.
1 secondary outcome
Quality of life-questionnaire (validated), EHP-30
Time frame: At the 7th menstruation i.e. after approximately 6 months.
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 6 Apr 2011.
- Derived from this study: PubMed 28844356Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
- Derived from this study: PubMed 23921822Wickstrom K, Spira J, Edelstam G. Serum concentration of lignocaine after pertubation: an observational study. Drugs R D. 2013 Sep;13(3):235-9. doi: 10.1007/s40268-013-0022-8.
- Derived from this study: PubMed 22232129Wickstrom K, Bruse C, Sjosten A, Spira J, Edelstam G. Pertubation with lignocaine as a new treatment of dysmenorrhea due to endometriosis: a randomized controlled trial. Hum Reprod. 2012 Mar;27(3):695-701. doi: 10.1093/humrep/der434. Epub 2012 Jan 9.
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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.
Karin Wickström, MD principal investigator
Danderyd Hospital, SE-182 88 Stockholm, Sweden
Greta Edelstam, MD study director
Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lignocaine and Ringers Solution in people with Endometriosis and Dysmenorrhea, run by Isifer AB at 3 sites in Sweden.
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 12 inclusion and 11 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 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. (time frame: After three pertubations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01329796, which also lists 3 linked publications.
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 6 Apr 2011.