Clinical trial NCT01942369: A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Infiltrating Endometriosis (DIE)
Keywords: Endometriosis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-09-16
Enrollment: 402
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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.

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
Secondary outcomes:
measure: Recurrence rate of specific endometriosis symptoms
timeFrame: At 12 months and 24 months
measure: Change during the study period in symptom(s) having the highest intensity at baseline
timeFrame: 24 months
measure: Rate of pregnancy in subjects
timeFrame: At 12 months and 24 months
measure: Abdominal pain-free interval
timeFrame: Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months
measure: Disease profile of DIE patients treated by Diphereline and by duration of treatment.
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital,Capital Medical University
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chongqing
country: China
facility: Xinqiao Hospital,Third Military Medical University
city: Chongqing
country: China
facility: Southwest Hospital,Chongqing,400038
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital,Hefei,China,230031
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital,Nanchang
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
city: Shanghai
country: China
facility: The International Peace Maternity & Child Health Hospital of China
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University,Taiyuan
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University (Hubei General Hospital)
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Sun 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.