Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Lucrin Depot® (Leuprorelin)

AbbVie (prior sponsor, Abbott)391 enrolled

Overview

The purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.

This was a non-interventional, observational program in which Lucrin Depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy). The rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the Russian Federation. Further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the Russian Federation.

Study Type

OBSERVATIONAL

Enrollment

391

Conditions

Genital Endometriosis

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age from 18 to 50 years * Written Patient Consent for Use/Disclosure of Data * Diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis) * Candidate for treatment with Lucrin Depot for 6-month course * Patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded Exclusion Criteria: * Contraindications to administration of Lucrin Depot (leuprorelin): * Hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition * Vaginal bleedings of unknown etiology * Hysterectomy * Pregnancy and lactation * Menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program) * Acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs * Other contraindications that make the patients participation impossible (by investigator judgment) * Previous enrollment in the present program * Extra-genital endometriosis

Locations (28)

Outcomes

Primary Outcomes

Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment

The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.

Time frame: 6 months

Secondary Outcomes

Percent Compliance to Treatment With Leuprorelin

Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed \* 100.

Time frame: 6 months

Participants With Estrogen Deficiency Symptoms

Estrogen deficiency symptoms include: * hot flashes, * headaches, * palpitations at rest, * insomnia, * fluctuation of mood.

Time frame: 6 months

Data from ClinicalTrials.gov

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