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
| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2011 | ||||
| Last Updated Date | January 2, 2013 | ||||
| Start Date ICMJE | February 2011 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01294371 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary care clinic |
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| Condition ICMJE | Genital Endometriosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Genital endometriosis
Planned for administration of Lucrin Depot patients with genital endometriosis |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 401 | ||||
| Completion Date | May 2012 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Russian Federation | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01294371 | ||||
| Other Study ID Numbers ICMJE | P12-762 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | AbbVie ( AbbVie (prior sponsor, Abbott) ) | ||||
| Study Sponsor ICMJE | AbbVie (prior sponsor, Abbott) | ||||
| Collaborators ICMJE | Almedis | ||||
| Investigators ICMJE |
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| Information Provided By | AbbVie | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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