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)

• ClinicalTrials.gov Identifier: NCT01942369
• Recruitment Status: Completed
• First Posted: September 16, 2013
• Last Update Posted: December 6, 2018
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Study Description

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.

Condition or disease	Intervention/treatment
Deep Infiltrating Endometriosis (DIE)	Drug: Triptorelin Acetate 3.75mg intramuscular injection

Study Design

• Study Type: Observational
• Actual Enrollment: 402 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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 Start Date: September 16, 2013
• Actual Primary Completion Date: July 13, 2018
• Actual Study Completion Date: July 13, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Deep Infiltrating Endometriosis (DIE)	Drug: Triptorelin Acetate 3.75mg intramuscular injection; 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.; Other Name: Diphereline 3.75mg intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. Changes in the intensity of specific endometriosis symptoms from baseline pre-surgery [ Time Frame: 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 :

1. Recurrence rate of specific endometriosis symptoms [ Time Frame: 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.
2. Change during the study period in symptom(s) having the highest intensity at baseline [ Time Frame: 24 months ]
   The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment.
3. Rate of pregnancy in subjects [ Time Frame: At 12 months and 24 months ]
4. Abdominal pain-free interval [ Time Frame: 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).
5. Disease profile of DIE patients treated by Diphereline and by duration of treatment. [ Time Frame: 24 months ]
   The disease profile (size of the lesion, locations etc…) will be detailed in each group of treatment duration by descriptive statistics.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

China

Beijing Anzhen Hospital,Capital Medical University

Beijing, China, 100029

Peking University People's Hospital

Beijing, China, 100044

Beijing Jishuitan Hospital

Beijing, China, 100096

Chinese PLA General Hospital

Beijing, China, 100853

Xinqiao Hospital,Third Military Medical University

Chongqing, China, 400037

Southwest Hospital,Chongqing,400038

Chongqing, China, 400038

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310006

Anhui Provincial Cancer Hospital,Hefei,China,230031

Hefei, China, 230031

Jiangxi Maternal and Child Health Hospital,Nanchang

Nanchang, China, 330008

Nanjing Maternity and Child Health Care Hospital

Nanjing, China, 210011

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, China, 200011

The International Peace Maternity & Child Health Hospital of China

Shanghai, China, 200030

Shanghai First Maternity and Infant Hospital

Shanghai, China, 201204

Shenzhen People's Hospital

Shenzhen, China, 518020

The Second Hospital of Shanxi Medical University,Taiyuan

Taiyuan, China, 030001

Huazhong University of Science and Technology

Wuhan, China, 430022

Renmin Hospital of Wuhan University (Hubei General Hospital)

Wuhan, China, 430060

Henan Provincial People's Hospital

Zhengzhou, China, 450008

Sponsors and Collaborators

Ipsen

Investigators

• Study Director: Ipsen Medical Director; Ipsen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT01942369
• Other Study ID Numbers: A-38-52014-210
• First Posted: September 16, 2013
• Last Update Posted: December 6, 2018
• Last Verified: December 2018

Keywords provided by Ipsen:

Endometriosis

Additional relevant MeSH terms:

Endometriosis; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Triptorelin Pamoate; Luteolytic Agents; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Antineoplastic Agents, Hormonal; Antineoplastic Agents