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
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|Condition or disease||Intervention/treatment|
|Deep Infiltrating Endometriosis (DIE)||Drug: Triptorelin Acetate 3.75mg intramuscular injection|
|Study Type :||Observational|
|Actual Enrollment :||402 participants|
|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|
|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
- 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).
- 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.
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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|
- 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.
- 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.
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
|Study Director:||Ipsen Medical Director||Ipsen|
|Other Study ID Numbers:||
|First Posted:||September 16, 2013 Key Record Dates|
|Last Update Posted:||December 6, 2018|
|Last Verified:||December 2018|
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal