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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

This study has been completed.
Sponsor:
Collaborator:
Almedis
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01294371
First received: February 10, 2011
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

400 eligible patients with endometriosis will be enrolled at 38 sites in Russia. Study medication will be administered by injection once a month. Planned duration of therapy 6 months. The rates of administration of hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, planned for a 6-month course of gonadoliberin agonist Lucrin Depot in patients with endometriosis will be described.


Condition
Genital Endometriosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Multi-center, Post-marketing,Observational Study 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.

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • The rates of administration of hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom [ Time Frame: For a duration for 6 months of observation ] [ Designated as safety issue: No ]
    To assess rates of administration of add-back therapy, in patients with endometriosis in Russian Federation, planned for 6-month course of gonadoliberin agonist Lucrin Depot


Secondary Outcome Measures:
  • The compliance to treatment with Lucrin Depot in patients with endometriosis [ Time Frame: For a duration of 6 months of observation ] [ Designated as safety issue: No ]
  • Adverse events for estrogen deficiency symptoms [ Time Frame: For a duration of 6 months of observation ] [ Designated as safety issue: Yes ]

Enrollment: 401
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Genital endometriosis
Planned for administration of Lucrin Depot patients with genital endometriosis

Detailed Description:

400 eligible patients with genital endometriosis will be enrolled at 38 sites in Russia. Study medication Lucrin Depot will be administered at a dose of 3.75 mg by intramuscular or subcutaneous injection once a month. The first injection will be carried out on the 3rd day of menstrual period. Planned duration of therapy 6 months. The rates of administration of hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, planned for a 6-month course of gonadoliberin agonist Lucrin Depot in patients with endometriosis will be described.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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 another reasons of 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
    • Surgical castration
    • 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
  • Extragenital endometriosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294371

Locations
Russian Federation
Site Reference ID/Investigator# 51643
Chelyabinsk, Russian Federation, 454092
Site Reference ID/Investigator# 50563
Ekaterinburg, Russian Federation, 620026
Site Reference ID/Investigator# 50577
Irkutsk, Russian Federation, 664003
Site Reference ID/Investigator# 50561
Izhevsk, Russian Federation, 426039
Site Reference ID/Investigator# 50560
Kazan, Russian Federation, 420043
Site Reference ID/Investigator# 50567
Moscow, Russian Federation, 117036
Site Reference ID/Investigator# 50565
Moscow, Russian Federation, 117997
Site Reference ID/Investigator# 50570
Moscow, Russian Federation, 101000
Site Reference ID/Investigator# 50564
Moscow, Russian Federation, 121552
Site Reference ID/Investigator# 62184
Nizhniy Novgorod, Russian Federation, 603057
Site Reference ID/Investigator# 50558
Nizhny Novgorod, Russian Federation, 603126
Site Reference ID/Investigator# 50557
Orenburg, Russian Federation, 460000
Site Reference ID/Investigator# 53156
Perm, Russian Federation, 614066
Site Reference ID/Investigator# 50545
Perm, Russian Federation, 614010
Site Reference ID/Investigator# 50556
Samara, Russian Federation, 443067
Site Reference ID/Investigator# 50555
Saratov, Russian Federation, 410028
Site Reference ID/Investigator# 50548
St. Petersburg, Russian Federation, 194291
Site Reference ID/Investigator# 50551
St. Petersburg, Russian Federation, 196247
Site Reference ID/Investigator# 50547
St. Petersburg, Russian Federation, 190000
Site Reference ID/Investigator# 50549
St. Petersburg, Russian Federation, 195257
Site Reference ID/Investigator# 50552
St. Petersburg, Russian Federation, 199034
Site Reference ID/Investigator# 50580
Stavropol, Russian Federation, 355030
Site Reference ID/Investigator# 50554
Stavropol, Russian Federation, 355002
Site Reference ID/Investigator# 50579
Tumen, Russian Federation, 625002
Site Reference ID/Investigator# 50575
Vladivostok, Russian Federation, 690600
Site Reference ID/Investigator# 50562
Volzhskiy, Volgograd Region, Russian Federation, 404130
Site Reference ID/Investigator# 48866
Voronezh, Russian Federation, 394000
Site Reference ID/Investigator# 54502
Voronezh, Russian Federation, 394006
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Almedis
Investigators
Study Director: Andrey Strugovshchikov, MD AbbVie
  More Information

Additional Information:
Webpage on use and safety of leuprorelin  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01294371     History of Changes
Other Study ID Numbers: P12-762
Study First Received: February 10, 2011
Last Updated: January 2, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:
Lucrin Depot
genital endometriosis
6 months therapy

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013