Compliance and Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619757
• Other study ID #: 69HCL22_0547
• Status: Completed
• Start date: November 17, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Behavioral:
• Compliance 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.

Locations

Country	Name	City	State
France	Service de Gynécologie-Obstétrique, Sénologie et Oncologie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes