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

February 10, 2011
January 2, 2013
February 2011
May 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01294371 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

Genital Endometriosis
Not Provided
Genital endometriosis
Planned for administration of Lucrin Depot patients with genital endometriosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01294371
P12-762
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Almedis
Study Director: Andrey Strugovshchikov, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP