EndometriosisNCT05619757
Compliance and Endometriosis
An observational study of Endometriosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Endometriosis is defined as the presence of hormone-dependent endometrial tissue outside the uterine cavity. It is a chronic, painful and often disabling pathology during the normal activities of daily life. It affects 10% of women of childbearing age. It is therefore a real public health issue. 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?
- Compliance with medical treatment for endometriosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2022to 17 May 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will include women with painful endometriosis who have never had endometriosis surgery. In addition, patients must speak and understand French and be over 18 years old.
Who may be able to join
- Be a woman with diagnosed painful endometriosis
- Have a prescription for medication (analgesics alone, hormone therapy alone or hormone therapy and analgesics).
- Speak and understand French
- Be a woman over 18 years old until menopause
- Agree to participate in the study
Who cannot join
- Be a woman who has already had surgery for endometriosis
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie-Obstétrique, Sénologie et Oncologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69500
About this study
Official title: Compliance With Medical Treatment for Endometriosis : a Cross-sectional Study
Endometriosis is defined as the presence of hormone-dependent endometrial tissue outside the uterine cavity. It is a chronic, painful and often disabling pathology during the normal activities of daily life. It affects 10% of women of childbearing age. It is therefore a real public health issue.
The latest recommendations from the HAS and the CNGOF now recommend primary medical management of endometriosis in painful women who do not wish to become pregnant. It should be remembered that until very recently, the teams resigned themselves to carrying out surgical interventions in order to support the diagnosis (this is histological and requires a biopsy) and to treat the patient if possible. Sometimes, this treatment was not possible from the outset, as the lesions appeared to be inaccessible, and additional hormonal treatment was therefore required. The current concept is to propose to patients a first hormonal suppressive treatment before a possible surgery. This therapeutic de-escalation should be considered in the light of the physiopathology of endometriosis, which is essentially based on the ovarian cycles, and indirectly on menstruation, which must then be suspended. However, a good number of patients are initially reluctant to undergo any kind of hormonal therapy, either because they have had a bad experience with hormonal contraception (intolerance) or because of a fear related to the possible complications of hormonal therapy with third or fourth generation pills, for example (thromboembolic risk). There is also a health alert at present concerning macro progestins in relation to the risk of meningioma. Acceptance of the principle of instituting amenorrhea in order to relieve patients suffering from endometriosis requires prior information. In investigator's daily practice, they frequently deplore non-compliance, which is detrimental to the proper management of the disease. The effectiveness of hormonal treatment, which will institute a quiescence of hormonal activity, is not immediate. An analgesic and anti-inflammatory treatment is then added. Investigators propose to compare the compliance of three drug strategies: analgesics alone, hormone therapy alone or hormone therapy and analgesics.
- Conditions
- Endometriosis
- Being tested
- Compliance with medical treatment for endometriosis
- Keywords
- Endometriosis, Pain, Drug treatments, Hormonal treatment, Compliance, Amenorrhea, Recommendations, Menstruation, Quality of life, Efficiency
- Medical subject headings
- Endometriosis, Pain, Patient Compliance, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance with medical treatment for endometriosisBehavioural
During their scheduled consultation at the Hôpital Femme Mère Enfant (HFME), women who meet the eligibility criteria will be presented with the study and given the written information note. If they agree to participate, the investigator will give them a QR code redirecting them to the online self-questionnaire.
Patients will be included once they log in and complete the questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance measured by the Morisky Medication Adherence Scales (MMAS-8).
This self-administered questionnaire validated in French has 8 items each scored 0 or 1. A high score indicates high compliance: high compliance (score = 8), average compliance (score of 6 to < 8) and low compliance (score < 6). Patients with a score greater than or equal to 6 will be considered as compliant. This questionnaire has been validated in French.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start17 Nov 2022
- Primary completion17 May 2023
- Study completion17 May 2023
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.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619757
- Sponsor's protocol ID
- 69HCL22_0547
- Status last verified
- May 2024
- First submitted
- 9 Nov 2022
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Medical Treatment for Endometriosis : a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05619757
- Acronym / sponsor ID
- 69HCL22_0547
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Pain, Drug treatments, Hormonal treatment, Compliance, Amenorrhea, Recommendations, Menstruation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- 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 defined as the presence of hormone-dependent endometrial tissue outside the uterine cavity. It is a chronic, painful and often disabling pathology during the normal activities of daily life. It affects 10% of women of childbearing age. It is therefore a real public health issue.
The latest recommendations from the HAS and the CNGOF now recommend primary medical management of endometriosis in painful women who do not wish to become pregnant. It should be remembered that until very recently, the teams resigned themselves to carrying out surgical interventions in order to support the diagnosis (this is histological and requires a biopsy) and to treat the patient if possible. Sometimes, this treatment was not possible from the outset, as the lesions appeared to be inaccessible, and additional hormonal treatment was therefore required. The current concept is to propose to patients a first hormonal suppressive treatment before a possible surgery. This therapeutic de-escalation should be considered in the light of the physiopathology of endometriosis, which is essentially based on the ovarian cycles, and indirectly on menstruation, which must then be suspended. However, a good number of patients are initially reluctant to undergo any kind of hormonal therapy, either because they have had a bad experience with hormonal contraception (intolerance) or because of a fear related to the possible complications of hormonal therapy with third or fourth generation pills, for example (thromboembolic risk). There is also a health alert at present concerning macro progestins in relation to the risk of meningioma. Acceptance of the principle of instituting amenorrhea in order to relieve patients suffering from endometriosis requires prior information. In investigator's daily practice, they frequently deplore non-compliance, which is detrimental to the proper management of the disease. The effectiveness of hormonal treatment, which will institute a quiescence of hormonal activity, is not immediate. An analgesic and anti-inflammatory treatment is then added. Investigators propose to compare the compliance of three drug strategies: analgesics alone, hormone therapy alone or hormone therapy and analgesics.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include women with painful endometriosis who have never had endometriosis surgery. In addition, patients must speak and understand French and be over 18 years old.
Key inclusion criteria (5 listed)
- Be a woman with diagnosed painful endometriosis
- Have a prescription for medication (analgesics alone, hormone therapy alone or hormone therapy and analgesics).
- Speak and understand French
- Be a woman over 18 years old until menopause
- Agree to participate in the study
Key exclusion criteria (1 listed)
- Be a woman who has already had surgery for endometriosis
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 |
|---|---|---|
| Compliance with medical treatment for endometriosisDuring their scheduled consultation at the Hôpital Femme Mère Enfant (HFME), women who meet the eligibility criteria will be presented with the study and given the written information note. If they agree to participate, the investigator will give them a QR code redirecting them to the online self-questionnaire. Patients will be included once they log in and complete the questionnaire. | Behavioural | – |
Primary outcome
Compliance measured by the Morisky Medication Adherence Scales (MMAS-8).
Time frame: 10 minutes
This self-administered questionnaire validated in French has 8 items each scored 0 or 1. A high score indicates high compliance: high compliance (score = 8), average compliance (score of 6 to < 8) and low compliance (score < 6). Patients with a score greater than or equal to 6 will be considered as compliant. This questionnaire has been validated in French.
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 20 May 2024.
- Individual participant dataSharing planned: No
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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.
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, run by Hospices Civils de Lyon at 1 site in France.
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 1 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 20 May 2024. 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 France. 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?
Compliance measured by the Morisky Medication Adherence Scales (MMAS-8). (time frame: 10 minutes). 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 20 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.