Deep Infiltrating Endometriosis (DIE)
Conditions
Keywords
Endometriosis
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.
Interventions
DRUGTriptorelin Acetate 3.75mg intramuscular injection
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.
Sponsors
Ipsen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of specific endometriosis symptoms | At 12 months and 24 months | Recurrence rate of specific endometriosis symptoms in the group of patients with mild or null symptoms score following surgery and Diphereline treatment. |
| Change during the study period in symptom(s) having the highest intensity at baseline | 24 months | The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment. |
| Rate of pregnancy in subjects | At 12 months and 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 | Assessed using a visual analogue scale (VAS). |
| Disease profile of DIE patients treated by Diphereline and by duration of treatment. | 24 months | The disease profile (size of the lesion, locations etc…) will be detailed in each group of treatment duration by descriptive statistics. |
Countries
China
Outcome results
None listed