A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
DIE-NIS
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.
1 other identifier
observational
402
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedStudy Start
First participant enrolled
September 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2018
CompletedDecember 6, 2018
December 1, 2018
4.8 years
September 10, 2013
December 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
Secondary Outcomes (5)
Recurrence rate of specific endometriosis symptoms
At 12 months and 24 months
Change during the study period in symptom(s) having the highest intensity at baseline
24 months
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
Disease profile of DIE patients treated by Diphereline and by duration of treatment.
24 months
Study Arms (1)
Deep Infiltrating Endometriosis (DIE)
Interventions
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 Criteria
Hospital patients who had been diagnosed with DIE, surgically treated and for whom decision has been made to be treated with a GnRHa post-surgery.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (18)
Beijing Anzhen Hospital,Capital Medical University
Beijing, 100029, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Jishuitan Hospital
Beijing, 100096, China
Chinese PLA General Hospital
Beijing, 100853, China
Xinqiao Hospital,Third Military Medical University
Chongqing, 400037, China
Southwest Hospital,Chongqing,400038
Chongqing, 400038, China
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, 310006, China
Anhui Provincial Cancer Hospital,Hefei,China,230031
Hefei, 230031, China
Jiangxi Maternal and Child Health Hospital,Nanchang
Nanchang, 330008, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, 210011, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, 200011, China
The International Peace Maternity & Child Health Hospital of China
Shanghai, 200030, China
Shanghai First Maternity and Infant Hospital
Shanghai, 201204, China
Shenzhen People's Hospital
Shenzhen, 518020, China
The Second Hospital of Shanxi Medical University,Taiyuan
Taiyuan, 030001, China
Huazhong University of Science and Technology
Wuhan, 430022, China
Renmin Hospital of Wuhan University (Hubei General Hospital)
Wuhan, 430060, China
Henan Provincial People's Hospital
Zhengzhou, 450008, China
Related Publications (2)
Zhu L, Guan Z, Huang Y, Hua K, Ma L, Zhang J, Yang D, Perrot V, Li H, Zhang X. The efficacy and safety of triptorelin-therapy following conservative surgery for deep infiltrating endometriosis: A multicenter, prospective, non-interventional study in China. Medicine (Baltimore). 2022 Feb 4;101(5):e28766. doi: 10.1097/MD.0000000000028766.
PMID: 35119037DERIVEDSun W, Hua K, Hong L, Zhang J, Hao M, Wang J, Zhang J, Perrot V, Li H, Zhang X. Symptom control after different duration of triptorelin treatment following conservative surgery for deep infiltrating endometriosis: Post-hoc analysis of a multicentre, prospective, real-world study. Medicine (Baltimore). 2021 Jul 30;100(30):e26753. doi: 10.1097/MD.0000000000026753.
PMID: 34397719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2013
First Posted
September 16, 2013
Study Start
September 16, 2013
Primary Completion
July 13, 2018
Study Completion
July 13, 2018
Last Updated
December 6, 2018
Record last verified: 2018-12