Clinical trial NCT05619757: Compliance and Endometriosis
Official title: Compliance With Medical Treatment for Endometriosis : a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis
Pain
Drug treatments
Hormonal treatment
Compliance
Amenorrhea
Recommendations
Menstruation
Quality of life
Efficiency
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compliance measured by the Morisky Medication Adherence Scales (MMAS-8).
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Gynécologie-Obstétrique, Sénologie et Oncologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Study officials:
References: