Deep Infiltrating Endometriosis (DIE) Clinical Trial
— DIE-NISOfficial 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.
| Verified date | December 2018 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 402 |
| Est. completion date | July 13, 2018 |
| Est. primary completion date | July 13, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Anzhen Hospital,Capital Medical University | Beijing | |
| China | Beijing Jishuitan Hospital | Beijing | |
| China | Chinese PLA General Hospital | Beijing | |
| China | Peking University People's Hospital | Beijing | |
| China | Southwest Hospital,Chongqing,400038 | Chongqing | |
| China | Xinqiao Hospital,Third Military Medical University | 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 | Obstetrics and Gynecology Hospital of Fudan University | Shanghai | |
| China | Shanghai First Maternity and Infant Hospital | Shanghai | |
| China | The International Peace Maternity & Child Health Hospital of China | Shanghai | |
| China | Shenzhen People's Hospital | Shenzhen | |
| China | The Second Hospital of Shanxi Medical University,Taiyuan | Taiyuan | |
| China | Huazhong University of Science and Technology | Wuhan | |
| China | Renmin Hospital of Wuhan University (Hubei General Hospital) | Wuhan | |
| China | Henan Provincial People's Hospital | Zhengzhou |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Recurrence rate of specific endometriosis symptoms | Recurrence rate of specific endometriosis symptoms in the group of patients with mild or null symptoms score following surgery and Diphereline treatment. | At 12 months and 24 months | |
| Secondary | Change during the study period in symptom(s) having the highest intensity at baseline | The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment. | 24 months | |
| Secondary | Rate of pregnancy in subjects | At 12 months and 24 months | ||
| Secondary | Abdominal pain-free interval | Assessed using a visual analogue scale (VAS). | Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months | |
| Secondary | Disease profile of DIE patients treated by Diphereline and by duration of treatment. | The disease profile (size of the lesion, locations etc…) will be detailed in each group of treatment duration by descriptive statistics. | 24 months |