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)

May 10, 2013 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

391

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Compliance to Treatment With Leuprorelin
Time Frame: 6 months
Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.
6 months
Participants With Estrogen Deficiency Symptoms
Time Frame: 6 months

Estrogen deficiency symptoms include:

  • hot flashes,
  • headaches,
  • palpitations at rest,
  • insomnia,
  • fluctuation of mood.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Almedis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-762

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Genital Endometriosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe