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)

Ipsen

Status: Completed

Conditions: Deep Infiltrating Endometriosis (DIE)

Treatments: Drug: Triptorelin Acetate 3.75mg intramuscular injection

Study type: Observational

Funder types: Industry

Identifiers

NCT01942369

A-38-52014-210

Details and patient eligibility

About

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.

Enrollment: 402 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

402 participants in 1 patient group

Deep Infiltrating Endometriosis (DIE)

Treatment:

Drug: Triptorelin Acetate 3.75mg intramuscular injection