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

Completed

• Conditions: Deep Infiltrating Endometriosis (DIE)
• Interventions: Drug: Triptorelin Acetate 3.75mg intramuscular injection

• Registration Number: NCT01942369
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-10
• Study Start: 2013-09-16
• Study First Posted: 2013-09-16
• Primary Completion: 2018-07-13
• Study Completion: 2018-07-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 402

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Deep Infiltrating Endometriosis (DIE)	Triptorelin Acetate 3.75mg intramuscular injection	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.
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	The disease profile (size of the lesion, locations etc...) will be detailed in each group of treatment duration by descriptive statistics.

Trial Locations

Locations (18)

Chinese PLA General Hospital; 🇨🇳 Beijing, China

Women's Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, China

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, China

Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Xinqiao Hospital,Third Military Medical University; 🇨🇳 Chongqing, China

Peking University People's Hospital; 🇨🇳 Beijing, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, China

Southwest Hospital,Chongqing,400038; 🇨🇳 Chongqing, China

Beijing Anzhen Hospital,Capital Medical University; 🇨🇳 Beijing, China

Anhui Provincial Cancer Hospital,Hefei,China,230031; 🇨🇳 Hefei, China

Jiangxi Maternal and Child Health Hospital,Nanchang; 🇨🇳 Nanchang, China

Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, China

Renmin Hospital of Wuhan University (Hubei General Hospital); 🇨🇳 Wuhan, China

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, China

The International Peace Maternity & Child Health Hospital of China; 🇨🇳 Shanghai, China

The Second Hospital of Shanxi Medical University,Taiyuan; 🇨🇳 Taiyuan, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, China