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)

December 5, 2018 updated by: Ipsen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100029
        • Beijing Anzhen Hospital，Capital Medical University
      • Beijing, China, 100096
        • Beijing Jishuitan Hospital
      • Chongqing, China, 400037
        • Xinqiao Hospital，Third Military Medical University
      • Chongqing, China, 400038
        • Southwest Hospital,Chongqing,400038
      • Hangzhou, China, 310006
        • Women's Hospital, School of Medicine, Zhejiang University
      • Hefei, China, 230031
        • Anhui Provincial Cancer Hospital,Hefei,China,230031
      • Nanchang, China, 330008
        • Jiangxi Maternal and Child Health Hospital,Nanchang
      • Nanjing, China, 210011
        • Nanjing Maternity and Child Health Care Hospital
      • Shanghai, China, 200011
        • Obstetrics and Gynecology Hospital of Fudan University
      • Shanghai, China, 200030
        • The International Peace Maternity & Child Health Hospital of China
      • Shanghai, China, 201204
        • Shanghai first maternity and infant hospital
      • Shenzhen, China, 518020
        • Shenzhen People's Hospital
      • Taiyuan, China, 030001
        • The Second Hospital of Shanxi Medical University,Taiyuan
      • Wuhan, China, 430060
        • Renmin Hospital of Wuhan University (Hubei General Hospital)
      • Wuhan, China, 430022
        • Huazhong University of Science and Technology
      • Zhengzhou, China, 450008
        • HeNan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Diphereline 3.75mg intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Every 3 months in the first 12 months after surgery and every 6 months in the following 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 months and 24 months
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.
24 months
Rate of pregnancy in subjects
Time Frame: At 12 months and 24 months
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).
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.
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 16, 2013

Primary Completion (ACTUAL)

July 13, 2018

Study Completion (ACTUAL)

July 13, 2018

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (ESTIMATE)

September 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52014-210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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