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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)

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Genital Endometriosis

Phase: N/A

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Andrey Strugovshchikov, MD, Study Director, Affiliation: AbbVie

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.

Clinical Details

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.

Study design: Time Perspective: Prospective

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

Secondary outcome:

Percent Compliance to Treatment With Leuprorelin

Participants With Estrogen Deficiency Symptoms

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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Site Reference ID/Investigator# 51643, Chelyabinsk 454092, Russian Federation

Site Reference ID/Investigator# 50563, Ekaterinburg 620026, Russian Federation

Site Reference ID/Investigator# 50577, Irkutsk 664003, Russian Federation

Site Reference ID/Investigator# 50561, Izhevsk 426039, Russian Federation

Site Reference ID/Investigator# 50560, Kazan 420043, Russian Federation

Site Reference ID/Investigator# 50564, Moscow 121552, Russian Federation

Site Reference ID/Investigator# 50565, Moscow 117997, Russian Federation

Site Reference ID/Investigator# 50567, Moscow 117036, Russian Federation

Site Reference ID/Investigator# 50570, Moscow 101000, Russian Federation

Site Reference ID/Investigator# 62184, Nizhniy Novgorod 603057, Russian Federation

Site Reference ID/Investigator# 50558, Nizhny Novgorod 603126, Russian Federation

Site Reference ID/Investigator# 50557, Orenburg 460000, Russian Federation

Site Reference ID/Investigator# 50545, Perm 614010, Russian Federation

Site Reference ID/Investigator# 53156, Perm 614066, Russian Federation

Site Reference ID/Investigator# 50556, Samara 443067, Russian Federation

Site Reference ID/Investigator# 50555, Saratov 410028, Russian Federation

Site Reference ID/Investigator# 50547, St. Petersburg 190000, Russian Federation

Site Reference ID/Investigator# 50548, St. Petersburg 194291, Russian Federation

Site Reference ID/Investigator# 50549, St. Petersburg 195257, Russian Federation

Site Reference ID/Investigator# 50551, St. Petersburg 196247, Russian Federation

Site Reference ID/Investigator# 50552, St. Petersburg 199034, Russian Federation

Site Reference ID/Investigator# 50554, Stavropol 355002, Russian Federation

Site Reference ID/Investigator# 50580, Stavropol 355030, Russian Federation

Site Reference ID/Investigator# 50579, Tumen 625002, Russian Federation

Site Reference ID/Investigator# 50575, Vladivostok 690600, Russian Federation

Site Reference ID/Investigator# 50562, Volzhskiy, Volgograd Region 404130, Russian Federation

Site Reference ID/Investigator# 48866, Voronezh 394000, Russian Federation

Site Reference ID/Investigator# 54502, Voronezh 394006, Russian Federation

Additional Information

Starting date: February 2011
Last updated: May 10, 2013

Page last updated: August 23, 2015

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