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

N/ACompletedNCT01942369

Ipsen402 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

402

Conditions

Deep Infiltrating Endometriosis (DIE)

Interventions

Triptorelin Acetate 3.75mg intramuscular injectionDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Beijing Anzhen Hospital,Capital Medical University

Beijing, China

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

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).

Time frame: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 24 months

Rate of pregnancy in subjects

Time frame: At 12 months and 24 months

Abdominal pain-free interval

Assessed using a visual analogue scale (VAS).

Time frame: 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.

Time frame: 24 months

Data from ClinicalTrials.gov

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