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)

NCT ID: NCT01294371

Last Updated: 2013-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 391 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-05-31

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.

Conditions

Genital Endometriosis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Leuprorelin

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Almedis

INDUSTRY

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Strugovshchikov, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 51643

Chelyabinsk, , Russia

Site Reference ID/Investigator# 50577

Irkutsk, , Russia

Site Reference ID/Investigator# 50561

Izhevsk, , Russia

Site Reference ID/Investigator# 50560

Kazan', , Russia

Site Reference ID/Investigator# 50570

Moscow, , Russia

Site Reference ID/Investigator# 50567

Moscow, , Russia

Site Reference ID/Investigator# 50565

Moscow, , Russia

Site Reference ID/Investigator# 50564

Moscow, , Russia

Site Reference ID/Investigator# 62184

Nizhny Novgorod, , Russia

Site Reference ID/Investigator# 50558

Nizhny Novgorod, , Russia

Site Reference ID/Investigator# 50557

Orenburg, , Russia

Site Reference ID/Investigator# 50545

Perm, , Russia

Site Reference ID/Investigator# 53156

Perm, , Russia

Site Reference ID/Investigator# 50547

Saint Petersburg, , Russia

Site Reference ID/Investigator# 50548

Saint Petersburg, , Russia

Site Reference ID/Investigator# 50549

Saint Petersburg, , Russia

Site Reference ID/Investigator# 50551

Saint Petersburg, , Russia

Site Reference ID/Investigator# 50552

Saint Petersburg, , Russia

Site Reference ID/Investigator# 50556

Samara, , Russia

Site Reference ID/Investigator# 50555

Saratov, , Russia

Site Reference ID/Investigator# 50554

Stavropol, , Russia

Site Reference ID/Investigator# 50580

Stavropol, , Russia

Site Reference ID/Investigator# 50579

Tyumen, , Russia

Site Reference ID/Investigator# 50575

Vladivostok, , Russia

Site Reference ID/Investigator# 50562

Volzhskiy, Volgograd Region, , Russia

Site Reference ID/Investigator# 48866

Voronezh, , Russia

Site Reference ID/Investigator# 54502

Voronezh, , Russia

Site Reference ID/Investigator# 50563

Yekaterinburg, , Russia

Countries

Russia

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P12-762

Identifier Type: -

Identifier Source: org_study_id