NCT01294371

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)

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-02-11
• Last updated: 2013-07-22
• Results posted: 2013-07-22

Locations

28 sites across 1 country: Russia