A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months
- Conditions
- Deep Infiltrating Endometriosis (DIE)
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 402
- 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.
- 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).
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.
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.
Trial Locations
- Locations (18)
Beijing Anzhen Hospital,Capital Medical University
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Beijing Jishuitan Hospital
🇨🇳Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Xinqiao Hospital,Third Military Medical University
🇨🇳Chongqing, China
Southwest Hospital,Chongqing,400038
🇨🇳Chongqing, China
Women's Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, China
Anhui Provincial Cancer Hospital,Hefei,China,230031
🇨🇳Hefei, China
Jiangxi Maternal and Child Health Hospital,Nanchang
🇨🇳Nanchang, China
Nanjing Maternity and Child Health Care Hospital
🇨🇳Nanjing, China
Scroll for more (8 remaining)Beijing Anzhen Hospital,Capital Medical University🇨🇳Beijing, China