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Completed

NCT Number: NCT01942369

A Study to Describe the Efficacy of Diphereline 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.

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Key information

Conditions

Deep Infiltrating Endometriosis (DIE) Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Anzhen Hospital,Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Diphereline 3.75mg intramuscular injection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Acronym: DIE-NIS

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2013
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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