Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Infiltrating Endometriosis (DIE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin Acetate 3.75mg intramuscular injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change during the study period in symptom(s) having the highest intensity at baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital,Capital Medical University | Beijing | 100029 | China | |||
| Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35119037 | Derived | 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. | |
| 34397719 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment. |
| 24 months |
| Rate of pregnancy in subjects | At 12 months and 24 months |
| 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 |
| 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 |
| 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 |
| 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. |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided