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Compliance and Endometriosis

Compliance With Medical Treatment for Endometriosis : a Cross-sectional Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05619757
Enrollment
58
Registered
2022-11-17
Start date
2022-11-17
Completion date
2023-05-17
Last updated
2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Endometriosis, Pain, Drug treatments, Hormonal treatment, Compliance, Amenorrhea, Recommendations, Menstruation, Quality of life, Efficiency

Brief 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. 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.

Interventions

BEHAVIORALCompliance with medical treatment for endometriosis

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\- Be a woman who has already had surgery for endometriosis

Design outcomes

Primary

MeasureTime frameDescription
Compliance measured by the Morisky Medication Adherence Scales (MMAS-8).10 minutesThis 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026