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)

Completed

Conditions: Genital Endometriosis

Registration Number: NCT01294371

Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 391

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (28): Site Reference ID/Investigator# 50545
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Perm, Russian Federation
Site Reference ID/Investigator# 50567
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Moscow, Russian Federation
Site Reference ID/Investigator# 51643
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Chelyabinsk, Russian Federation
Site Reference ID/Investigator# 53156
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Perm, Russian Federation
Site Reference ID/Investigator# 50552
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 50563
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Ekaterinburg, Russian Federation
Site Reference ID/Investigator# 50565
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Moscow, Russian Federation
Site Reference ID/Investigator# 50579
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Tumen, Russian Federation
Site Reference ID/Investigator# 50570
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Moscow, Russian Federation
Site Reference ID/Investigator# 50560
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Kazan, Russian Federation
Site Reference ID/Investigator# 50561
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Izhevsk, Russian Federation
Site Reference ID/Investigator# 50577
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Irkutsk, Russian Federation
Site Reference ID/Investigator# 50558
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Nizhny Novgorod, Russian Federation
Site Reference ID/Investigator# 62184
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Nizhniy Novgorod, Russian Federation
Site Reference ID/Investigator# 50564
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Moscow, Russian Federation
Site Reference ID/Investigator# 50557
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Orenburg, Russian Federation
Site Reference ID/Investigator# 50548
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 50547
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 50556
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Samara, Russian Federation
Site Reference ID/Investigator# 50549
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 50555
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Saratov, Russian Federation
Site Reference ID/Investigator# 50551
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 50554
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Stavropol, Russian Federation
Site Reference ID/Investigator# 50580
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Stavropol, Russian Federation
Site Reference ID/Investigator# 50562
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Volzhskiy, Volgograd Region, Russian Federation
Site Reference ID/Investigator# 50575
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Vladivostok, Russian Federation
Site Reference ID/Investigator# 48866
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Voronezh, Russian Federation
Site Reference ID/Investigator# 54502
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Voronezh, Russian Federation