A Study to Describe the Efficacy of Diphereline Following Conservative Surgery in Deep Infiltrating Endometriosis (DIE) Patients Over a Period of 24 Months

• Status: Completed
• Trial end date: 2018-07-13
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Triptorelin Pamoate

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.