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)

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prospective, Multi-Center, Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Gonadoliberin Agonist Lucrin Depot.

Conditions
-----------------
Genital Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leuprorelin<br>Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period. Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Compliance to Treatment With Leuprorelin | Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100. | 6 months | 
| Participants With Estrogen Deficiency Symptoms | Estrogen deficiency symptoms include: hot flashes, headaches, palpitations at rest, insomnia, fluctuation of mood. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lucrin Depot, genital endometriosis, 6 months therapy