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.
Overview
- Phase
- Not Applicable
- Intervention
- Triptorelin Acetate 3.75mg intramuscular injection
- Conditions
- Deep Infiltrating Endometriosis (DIE)
- Sponsor
- Ipsen
- Enrollment
- 402
- Locations
- 18
- Primary Endpoint
- Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Deep Infiltrating Endometriosis (DIE)
Intervention: Triptorelin Acetate 3.75mg intramuscular injection
Outcomes
Primary Outcomes
Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery
Time Frame: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
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).
Secondary Outcomes
- Change during the study period in symptom(s) having the highest intensity at baseline(24 months)
- Abdominal pain-free interval(Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months)
- Recurrence rate of specific endometriosis symptoms(At 12 months and 24 months)
- Rate of pregnancy in subjects(At 12 months and 24 months)
- Disease profile of DIE patients treated by Diphereline and by duration of treatment.(24 months)