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Trial record 2 of 14 for:    Triptorelin | endometriosis

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)

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942369


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01942369    
Other Study ID Numbers: A-38-52014-210
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Keywords provided by Ipsen:
Endometriosis
Additional relevant MeSH terms:
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Endometriosis
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents