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A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months

Completed
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
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Deep Infiltrating Endometriosis (DIE)Triptorelin Acetate 3.75mg intramuscular injection-
Primary Outcome Measures
NameTimeMethod
Changes in the intensity of specific endometriosis symptoms from baseline pre-surgeryEvery 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
NameTimeMethod
Change during the study period in symptom(s) having the highest intensity at baseline24 months

The highest intensity at baseline is defined as the symptom with the highest score on pre-surgery assessment.

Abdominal pain-free intervalEvery 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 subjectsAt 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 symptomsAt 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

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Beijing Anzhen Hospital,Capital Medical University
🇨🇳Beijing, China

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