A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months

Study Overview
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Brief Summary
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The purpose of this study is to describe changes in the intensity of specific endometriosis symptoms from baseline pre-surgery to after surgery and subsequent continuous Diphereline (Triptorelin Acetate) treatment for up to 24 weeks.

Official Title
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A Multi-centre, Prospective, Non-interventional Study to Describe the Efficacy of a Continuous up to 24-week Treatment of Diphereline 3.75mg Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months.

Conditions
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Deep Infiltrating Endometriosis (DIE)

Intervention / Treatment
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* Drug: Triptorelin Acetate 3.75mg intramuscular injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with DIE and having received surgery treatment within one month before inclusion Premenopausal women aged >=18 years old. Written ICF has been obtained prior to any study-related procedures Patient for whom the treating physician already made the decision to treat by Diphereline. Patient should be mentally and physically able to express her symptom complaints and answer questions. Exclusion Criteria: Pregnancy or lactation. Patients currently on treatment or who have been on therapy with a GnRHa in the last 6 months. Premenopausal women who may reach menopause within the 3 years post randomisation. Hypersensitivity to Triptorelin or one of the excipients of Triptorelin 3.75mg Treatment with another research drug over the last 3 months before the study Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deep Infiltrating Endometriosis (DIE)<br> | Drug: Triptorelin Acetate 3.75mg intramuscular injection<br>* Triptorelin Acetate is a Gonadotrophin Releasing Hormone agonist (GnRHa). Triptorelin acetate for injection 3.75mg administered as described in the patient information sheet approved in China: one intramuscular injection of the product repeated every 4 weeks.<br>* Other names: Diphereline 3.75mg intramuscular injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery | The specific endometriosis symptoms include pelvic pain, dysmenorrhoea, pain at time of ovulation, dyspareunia to be assessed with a 10-cm visual analogue scale (VAS). Other symptoms (Amenorrhea, menorrhagia, metrorrhagia, Global GI symptoms & urinary discomfort,) will be assessed by oral enquiry to the patients based on numerical scale from 0 to 10 (0 being the best and 10 the worst status). | Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of specific endometriosis symptoms | Recurrence rate of specific endometriosis symptoms in the group of patients with mild or null symptoms score following surgery and Diphereline treatment. | At 12 months and 24 months | 
| Change during the study period in symptom(s) having the highest intensity at baseline | The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment. | 24 months | 
| Rate of pregnancy in subjects |  | At 12 months and 24 months | 
| Abdominal pain-free interval | Assessed using a visual analogue scale (VAS). | Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months | 
| Disease profile of DIE patients treated by Diphereline and by duration of treatment. | The disease profile (size of the lesion, locations etc…) will be detailed in each group of treatment duration by descriptive statistics. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis