Completed
OBSERVATIONAL
NCT01942369
A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
View on ClinicalTrials.gov
Updated Dec 15, 2025
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
Name:
Triptorelin Acetate 3.75mg intramuscular injection
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery
TimeFrame:
Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
Description:
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).
Trial Information
NCT ID
NCT01942369
Status
Completed
Study Type
OBSERVATIONAL
Sponsor
Ipsen
Last Updated
December 15, 2025