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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-16

Study Completion Date

2018-07-13

Brief Summary

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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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Detailed Description

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Conditions

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Deep Infiltrating Endometriosis (DIE)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Deep Infiltrating Endometriosis (DIE)

Triptorelin Acetate 3.75mg intramuscular injection

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Diphereline 3.75mg intramuscular injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No