EndometriosisNCT02511626
Quality of Life in Endometriosis - a Case Control Study
An observational study of Endometriosis and Quality of Life, run by University of Zurich at 1 site in Switzerland.
Trial summary
Endometriosis, one of the most common diseases of women during their reproductive period., may present a chronic disabling disease with major impact on women's life. Therapeutic options are limited and recurrence of disease symptoms is frequent. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Quality of Life, Pain
- How many people
- 1,267 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female Age >18 Case group: women with endometriosis Healthy volunteers in control group
Who may be able to join
- female >18 years fluent German
- Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain
Who cannot join
- male (Except for partner questionnaires)
- <18years
- not fluent in German
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Reproductive Endocrinology, University Hospital Zurich
Zurich, 8091
About this study
Official title: Quality of Life in Endometriosis - a Case Control Study Using Internationally Validated Questionnaires
Endometriosis, one of the most common diseases of women during their reproductive period., may present a chronic disabling disease with major impact on women's life. Therapeutic options are limited and recurrence of disease symptoms is frequent.
The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.
A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women's partners. All diagnosis of endometriosis and classification of ASRM (American Society for Reproductive Medicine) disease stages are based on woman's medical charts.
Read the detailed description
With a prevalence of 7-10% endometriosis is one of the most common diseases of women during their reproductive period. There is a broad range of clinical symptoms of endometriosis, which may vary between an incidental asymptomatic finding and a chronic severely painful disease. Symptoms are nearly independent from disease stage and current therapeutic options do not permit to reliably reduce symptoms to an acceptable level. Independent from the therapy chosen, about 20% of women re-develop clinical symptoms in the first year and another 50% within a period of five years.
The currently provided medical support concentrates on surgical and medical i.e. hormonal options. Although it seems evident that endometriosis-associated pain will have a serious impact on the daily life of women attaint and there is a broad literature on the effect of other chronic pain diseases on patients' lives, comparable data for endometriosis are rare. Also, support models to allow women to integrate a chronic endometriosis into their daily life are currently lacking. To provide a reliable basis for the development of better holistic support models, the current study collects data on different aspects of the quality of life in a minimum of 600 women with different stages of endometriosis and a minimum of 600 control women matched for age (± 3 years) and nationality. To evaluate which features of the quality of life are specific for endometriosis a second control group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany and Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.
A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. The questionnaire includes basic socio-demographic data, life style parameters, a general as well as gynaeco-obstetric history including detailed questions on the diagnosis, treatment and current symptoms of endometriosis. In addition questionnaires on pain (modified version of the Brief Pain Inventory (BPI), Pain Disability Index (PDI), resources (SOC), stress perception (PSQ20), professional development, satisfaction with medical support, adverse childhood experiences (modified version of the childhood trauma questionnaire (CTQ), daily life, partnership (Partnerschaftsfragebogen, PFB), sexuality (modified version of the Brief Index of Sexual Functioning and Global sexual functioning) and anxiety/depression (PHQ, GAD) have to be completed by study participants. Socio-demographic questions, questions on partnership as well as on the estimated impact of endometriosis on partnership /sexuality were also given to study participants' partners. In addition to the current quality of life potential risk factors for the development of endometriosis e.g. traumatic childhood experiences are evaluated as well as satisfaction with medical support are evaluated.
All diagnosis of endometriosis and classification of ASRM disease stages are based on woman's medical charts.
- Conditions
- Endometriosis, Quality of Life, Pain, Sexuality, Anxiety, Depression
- Keywords
- endometriosis, quality of life, professional activity, pain, infertility, sexuality, partnership, anxiety, depression, stress, childhood trauma, medical support, dyspareunia
- Medical subject headings
- Endometriosis, Pain, Sexuality, Anxiety Disorders, Depression, Infertility, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Women with a surgically confirmed diagnosis of endometriosis | |
| Control group 1 | Women without any evidence of endometriosis (= no clinical symptom and/or no surgical evidence of endometriosis) | |
| Control group 2 | Women without endometriosis (surgically confirmed) but chronic abdominal/pelvic pain due to other reasons (e.g. Crohn's disease, colitis etc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life i.e. pain, infertility, partnership, sexuality, depression, anxiety, stress, medical support, comorbidities and risk factors in the development of endometriosis: childhood trauma, life style factors, menstrual history
The outcome measures are assessed with internationally validated questionnaires i.e. modified version of the Brief Pain Inventory and Pain Disability Index, modified Form des Childhood Trauma Questionnaire, Brief Symptom Inventory, partnership questionnaire (PFB), modified version of the Brief Index of Sexual Functioning und Global sexual functioning, Hospital Anxiety and Depression Scale (HADS) as well as the questionnaire on life satisfaction (FLZ)
Measured: The questionnaire is answered once after at inclusion in the study, different questions cover different time periods ranging from childhood (0-17 years) to the actual situation (last 4 weeks/ 24hours) as specified in the questionnaire
Secondary outcomes (2)
Prevalences of diseases such as dyspareunia, sexual disorders or adverse childhood experiences in the control group.
Measurements with internationally validated questionnaires and womens' medical history according to medical charts
Measured: Once at inclusion in the study
Comorbidity of chronic pain.
Measurements with internationally validated questionnaires and womens' medical history according to medical charts
Measured: Once at inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Triemli Hospital, Cantonal Hospital of St. Gallen, Kantonsspital Baden, Kantonsspital Winterthur KSW, Kantonsspital Schaffhausen, Charite University, Berlin, Germany, University Hospital, Aachen, Vivantes Kliniken Berlin, Medical University of Graz
- Responsible party
- Sponsor
- Investigators
- Brigitte Leeners, Prof. Dr., Principal investigator, Clinic for Reproductive Endocrinology, University Hospital Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511626
- Sponsor's protocol ID
- Endo_QOL
- Status last verified
- Sep 2022
- First submitted
- 20 Jul 2015
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Candan A, Kohl Schwartz A, Birchler K, Leeners B. Psychosomatic comorbidity in endometriosis: A multi-center, cross-sectional study identifying an underestimated factor in current medical support. J Psychosom Res. 2025 Sep;196:112346. doi: 10.1016/j.jpsychores.2025.112346. Epub 2025 Aug 9.
PubMed 40815907El Hadad S, Schwartz ASK, Gassner C, Haeberlin F, von Orelli S, Imesch P, Leeners B. Partnership and relationship happiness in endometriosis related chronic pelvic pain: a multicenter case-control study. Front Psychol. 2024 Oct 14;15:1382067. doi: 10.3389/fpsyg.2024.1382067. eCollection 2024.
PubMed 39469237El-Hadad S, Lasser D, Sachs MK, Schwartz ASK, Haeberlin F, von Orelli S, Eberhard M, Leeners B. Dysmenorrhea in adolescents requires careful investigation of endometriosis-an analysis of early menstrual experiences in a large case-control study. Front Reprod Health. 2023 Aug 25;5:1121515. doi: 10.3389/frph.2023.1121515. eCollection 2023.
PubMed 37693279Sperschneider ML, Hengartner MP, Kohl-Schwartz A, Geraedts K, Rauchfuss M, Woelfler MM, Haeberlin F, von Orelli S, Eberhard M, Maurer F, Imthurn B, Imesch P, Leeners B. Does endometriosis affect professional life? A matched case-control study in Switzerland, Germany and Austria. BMJ Open. 2019 Jan 9;9(1):e019570. doi: 10.1136/bmjopen-2017-019570.
PubMed 30782670Ramin-Wright A, Schwartz ASK, Geraedts K, Rauchfuss M, Wolfler MM, Haeberlin F, von Orelli S, Eberhard M, Imthurn B, Imesch P, Fink D, Leeners B. Fatigue - a symptom in endometriosis. Hum Reprod. 2018 Aug 1;33(8):1459-1465. doi: 10.1093/humrep/dey115.
PubMed 29947766Liebermann C, Kohl Schwartz AS, Charpidou T, Geraedts K, Rauchfuss M, Wolfler M, von Orelli S, Haberlin F, Eberhard M, Imesch P, Imthurn B, Leeners B. Maltreatment during childhood: a risk factor for the development of endometriosis? Hum Reprod. 2018 Aug 1;33(8):1449-1458. doi: 10.1093/humrep/dey111.
PubMed 29947745Kohl Schwartz AS, Wolfler MM, Mitter V, Rauchfuss M, Haeberlin F, Eberhard M, von Orelli S, Imthurn B, Imesch P, Fink D, Leeners B. Endometriosis, especially mild disease: a risk factor for miscarriages. Fertil Steril. 2017 Nov;108(5):806-814.e2. doi: 10.1016/j.fertnstert.2017.08.025.
PubMed 29079275
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Endometriosis - a Case Control Study Using Internationally Validated Questionnaires
- ClinicalTrials.gov ID
- NCT02511626
- Acronym / sponsor ID
- Endo_QOL
- Conditions
- Endometriosis, Quality of Life, Pain, Sexuality, Anxiety, Depression
- Keywords
- endometriosis, quality of life, professional activity, pain, infertility, sexuality, partnership, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,267 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Triemli Hospital, Cantonal Hospital of St. Gallen, Kantonsspital Baden, Kantonsspital Winterthur KSW, Kantonsspital Schaffhausen, Charite University, Berlin, Germany, University Hospital, Aachen, Vivantes Kliniken Berlin, Medical University of Graz
- Study start
- Jan 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Jul 2015 (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, one of the most common diseases of women during their reproductive period., may present a chronic disabling disease with major impact on women's life. Therapeutic options are limited and recurrence of disease symptoms is frequent.
The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.
A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women's partners. All diagnosis of endometriosis and classification of ASRM (American Society for Reproductive Medicine) disease stages are based on woman's medical charts.
Detailed description
With a prevalence of 7-10% endometriosis is one of the most common diseases of women during their reproductive period. There is a broad range of clinical symptoms of endometriosis, which may vary between an incidental asymptomatic finding and a chronic severely painful disease. Symptoms are nearly independent from disease stage and current therapeutic options do not permit to reliably reduce symptoms to an acceptable level. Independent from the therapy chosen, about 20% of women re-develop clinical symptoms in the first year and another 50% within a period of five years.
The currently provided medical support concentrates on surgical and medical i.e. hormonal options. Although it seems evident that endometriosis-associated pain will have a serious impact on the daily life of women attaint and there is a broad literature on the effect of other chronic pain diseases on patients' lives, comparable data for endometriosis are rare. Also, support models to allow women to integrate a chronic endometriosis into their daily life are currently lacking. To provide a reliable basis for the development of better holistic support models, the current study collects data on different aspects of the quality of life in a minimum of 600 women with different stages of endometriosis and a minimum of 600 control women matched for age (± 3 years) and nationality. To evaluate which features of the quality of life are specific for endometriosis a second control group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany and Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.
A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. The questionnaire includes basic socio-demographic data, life style parameters, a general as well as gynaeco-obstetric history including detailed questions on the diagnosis, treatment and current symptoms of endometriosis. In addition questionnaires on pain (modified version of the Brief Pain Inventory (BPI), Pain Disability Index (PDI), resources (SOC), stress perception (PSQ20), professional development, satisfaction with medical support, adverse childhood experiences (modified version of the childhood trauma questionnaire (CTQ), daily life, partnership (Partnerschaftsfragebogen, PFB), sexuality (modified version of the Brief Index of Sexual Functioning and Global sexual functioning) and anxiety/depression (PHQ, GAD) have to be completed by study participants. Socio-demographic questions, questions on partnership as well as on the estimated impact of endometriosis on partnership /sexuality were also given to study participants' partners. In addition to the current quality of life potential risk factors for the development of endometriosis e.g. traumatic childhood experiences are evaluated as well as satisfaction with medical support are evaluated.
All diagnosis of endometriosis and classification of ASRM disease stages are based on woman's medical charts.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Women with a surgically confirmed diagnosis of endometriosis |
| Control group 1 | – | –Women without any evidence of endometriosis (= no clinical symptom and/or no surgical evidence of endometriosis) |
| Control group 2 | – | –Women without endometriosis (surgically confirmed) but chronic abdominal/pelvic pain due to other reasons (e.g. Crohn's disease, colitis etc) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female Age >18 Case group: women with endometriosis Healthy volunteers in control group
Key inclusion criteria (2 listed)
- female >18 years fluent German
- Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain
Key exclusion criteria (3 listed)
- male (Except for partner questionnaires)
- <18years
- not fluent in German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life i.e. pain, infertility, partnership, sexuality, depression, anxiety, stress, medical support, comorbidities and risk factors in the development of endometriosis: childhood trauma, life style factors, menstrual history
Time frame: The questionnaire is answered once after at inclusion in the study, different questions cover different time periods ranging from childhood (0-17 years) to the actual situation (last 4 weeks/ 24hours) as specified in the questionnaire
The outcome measures are assessed with internationally validated questionnaires i.e. modified version of the Brief Pain Inventory and Pain Disability Index, modified Form des Childhood Trauma Questionnaire, Brief Symptom Inventory, partnership questionnaire (PFB), modified version of the Brief Index of Sexual Functioning und Global sexual functioning, Hospital Anxiety and Depression Scale (HADS) as well as the questionnaire on life satisfaction (FLZ)
2 secondary outcomes
Prevalences of diseases such as dyspareunia, sexual disorders or adverse childhood experiences in the control group.
Time frame: Once at inclusion in the study
Comorbidity of chronic pain.
Time frame: Once at inclusion in the study
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 28 Sep 2022.
- Derived from this study: PubMed 40815907Candan A, Kohl Schwartz A, Birchler K, Leeners B. Psychosomatic comorbidity in endometriosis: A multi-center, cross-sectional study identifying an underestimated factor in current medical support. J Psychosom Res. 2025 Sep;196:112346. doi: 10.1016/j.jpsychores.2025.112346. Epub 2025 Aug 9.
- Derived from this study: PubMed 39469237El Hadad S, Schwartz ASK, Gassner C, Haeberlin F, von Orelli S, Imesch P, Leeners B. Partnership and relationship happiness in endometriosis related chronic pelvic pain: a multicenter case-control study. Front Psychol. 2024 Oct 14;15:1382067. doi: 10.3389/fpsyg.2024.1382067. eCollection 2024.
- Derived from this study: PubMed 37693279El-Hadad S, Lasser D, Sachs MK, Schwartz ASK, Haeberlin F, von Orelli S, Eberhard M, Leeners B. Dysmenorrhea in adolescents requires careful investigation of endometriosis-an analysis of early menstrual experiences in a large case-control study. Front Reprod Health. 2023 Aug 25;5:1121515. doi: 10.3389/frph.2023.1121515. eCollection 2023.
- Derived from this study: PubMed 30782670Sperschneider ML, Hengartner MP, Kohl-Schwartz A, Geraedts K, Rauchfuss M, Woelfler MM, Haeberlin F, von Orelli S, Eberhard M, Maurer F, Imthurn B, Imesch P, Leeners B. Does endometriosis affect professional life? A matched case-control study in Switzerland, Germany and Austria. BMJ Open. 2019 Jan 9;9(1):e019570. doi: 10.1136/bmjopen-2017-019570.
- Derived from this study: PubMed 29947766Ramin-Wright A, Schwartz ASK, Geraedts K, Rauchfuss M, Wolfler MM, Haeberlin F, von Orelli S, Eberhard M, Imthurn B, Imesch P, Fink D, Leeners B. Fatigue - a symptom in endometriosis. Hum Reprod. 2018 Aug 1;33(8):1459-1465. doi: 10.1093/humrep/dey115.
- Derived from this study: PubMed 29947745Liebermann C, Kohl Schwartz AS, Charpidou T, Geraedts K, Rauchfuss M, Wolfler M, von Orelli S, Haberlin F, Eberhard M, Imesch P, Imthurn B, Leeners B. Maltreatment during childhood: a risk factor for the development of endometriosis? Hum Reprod. 2018 Aug 1;33(8):1449-1458. doi: 10.1093/humrep/dey111.
- Derived from this study: PubMed 29079275Kohl Schwartz AS, Wolfler MM, Mitter V, Rauchfuss M, Haeberlin F, Eberhard M, von Orelli S, Imthurn B, Imesch P, Fink D, Leeners B. Endometriosis, especially mild disease: a risk factor for miscarriages. Fertil Steril. 2017 Nov;108(5):806-814.e2. doi: 10.1016/j.fertnstert.2017.08.025.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Brigitte Leeners, Prof. Dr. principal investigator
Clinic for Reproductive Endocrinology, University Hospital Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Quality of Life, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 3 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 28 Sep 2022. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Quality of life i.e. pain, infertility, partnership, sexuality, depression, anxiety, stress, medical support, comorbidities and risk factors in the development of endometriosis: childhood trauma, life style factors, menstrual history (time frame: The questionnaire is answered once after at inclusion in the study, different questions cover different time periods ranging from childhood (0-17 years) to the actual situation (last 4 weeks/ 24hours) as specified in the questionnaire). 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 NCT02511626, which also lists 7 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 28 Sep 2022.