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)

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: May 10, 2013
Last verified: May 2013

February 10, 2011
May 10, 2013
February 2011
May 2012   (final data collection date for primary outcome measure)
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
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
Complete list of historical versions of study NCT01294371 on ClinicalTrials.gov Archive Site
  • Percent Compliance to Treatment With Leuprorelin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.
  • Participants With Estrogen Deficiency Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Estrogen deficiency symptoms include:

    • hot flashes,
    • headaches,
    • palpitations at rest,
    • insomnia,
    • fluctuation of mood.
  • 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 ]
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® (Leuprorelin)
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.

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.

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.

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

Primary care clinic

Genital Endometriosis
Not Provided
Leuprorelin

Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.

Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
391
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 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
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
May 2013

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