Clinical trial 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)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Endometriosis
Keywords: Lucrin Depot
genital endometriosis
6 months therapy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Almedis
First posted: 2011-02-11
Enrollment: 391
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.

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

Primary outcomes:
measure: Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
timeFrame: 6 months
Secondary outcomes:
measure: Percent Compliance to Treatment With Leuprorelin
timeFrame: 6 months
measure: Participants With Estrogen Deficiency Symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Site Reference ID/Investigator# 51643
city: Ekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50563
city: Irkutsk
country: Russian Federation
facility: Site Reference ID/Investigator# 50577
city: Izhevsk
country: Russian Federation
facility: Site Reference ID/Investigator# 50561
city: Kazan
country: Russian Federation
facility: Site Reference ID/Investigator# 50560
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 50570
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 50567
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 50565
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 50564
city: Nizhniy Novgorod
country: Russian Federation
facility: Site Reference ID/Investigator# 62184
city: Nizhny Novgorod
country: Russian Federation
facility: Site Reference ID/Investigator# 50558
city: Orenburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50557
city: Perm
country: Russian Federation
facility: Site Reference ID/Investigator# 50545
city: Perm
country: Russian Federation
facility: Site Reference ID/Investigator# 53156
city: Samara
country: Russian Federation
facility: Site Reference ID/Investigator# 50556
city: Saratov
country: Russian Federation
facility: Site Reference ID/Investigator# 50555
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50547
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50548
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50549
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50551
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 50552
city: Stavropol
country: Russian Federation
facility: Site Reference ID/Investigator# 50554
city: Stavropol
country: Russian Federation
facility: Site Reference ID/Investigator# 50580
city: Tumen
country: Russian Federation
facility: Site Reference ID/Investigator# 50579
city: Vladivostok
country: Russian Federation
facility: Site Reference ID/Investigator# 50575
city: Volzhskiy, Volgograd Region
country: Russian Federation
facility: Site Reference ID/Investigator# 50562
city: Voronezh
country: Russian Federation
facility: Site Reference ID/Investigator# 48866
city: Voronezh
country: Russian Federation
facility: Site Reference ID/Investigator# 54502
Study officials:
affiliation: AbbVie
name: Andrey Strugovshchikov, MD
role: STUDY_DIRECTOR
References: