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

Tracking Information

• First Submitted Date: September 10, 2013
• First Posted Date: September 16, 2013
• Last Update Posted Date: December 6, 2018
• Study Start Date: September 16, 2013
• Actual Primary Completion Date: July 13, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2017)

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).

Original Primary Outcome Measures (submitted: September 10, 2013)

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).

Current Secondary Outcome Measures (submitted: October 27, 2017)

• 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.
• 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.
• Rate of pregnancy in subjects [ Time Frame: At 12 months and 24 months ]
• 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).
• 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.

Original Secondary Outcome Measures (submitted: September 10, 2013)

• 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.
• Rate of pregnancy in subjects [ Time Frame: At 12 months and 24 months ]
• 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).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Deep Infiltrating Endometriosis (DIE)

Intervention

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

Study Groups/Cohorts

Deep Infiltrating Endometriosis (DIE)

Intervention: Drug: Triptorelin Acetate 3.75mg intramuscular injection

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 23, 2018): 402
• Original Estimated Enrollment (submitted: September 10, 2013): 400
• Actual Study Completion Date: July 13, 2018
• Actual Primary Completion Date: July 13, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01942369
• Other Study ID Numbers: A-38-52014-210
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ipsen
• Original Responsible Party: Same as current
• Current Study Sponsor: Ipsen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ipsen Medical Director; Ipsen

• PRS Account: Ipsen
• Verification Date: December 2018