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| Name | Class |
|---|---|
| Almedis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Compliance to Treatment With Leuprorelin | Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100. | 6 months |
| Participants With Estrogen Deficiency Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to administration of Lucrin Depot (leuprorelin):
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
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Strugovshchikov, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 51643 | Chelyabinsk | 454092 | Russia | |||
| Site Reference ID/Investigator# 50577 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Estrogen deficiency symptoms include:
| 6 months |
| Irkutsk |
| 664003 |
| Russia |
| Site Reference ID/Investigator# 50561 | Izhevsk | 426039 | Russia |
| Site Reference ID/Investigator# 50560 | Kazan' | 420043 | Russia |
| Site Reference ID/Investigator# 50570 | Moscow | 101000 | Russia |
| Site Reference ID/Investigator# 50567 | Moscow | 117036 | Russia |
| Site Reference ID/Investigator# 50565 | Moscow | 117997 | Russia |
| Site Reference ID/Investigator# 50564 | Moscow | 121552 | Russia |
| Site Reference ID/Investigator# 62184 | Nizhny Novgorod | 603057 | Russia |
| Site Reference ID/Investigator# 50558 | Nizhny Novgorod | 603126 | Russia |
| Site Reference ID/Investigator# 50557 | Orenburg | 460000 | Russia |
| Site Reference ID/Investigator# 50545 | Perm | 614010 | Russia |
| Site Reference ID/Investigator# 53156 | Perm | 614066 | Russia |
| Site Reference ID/Investigator# 50547 | Saint Petersburg | 190000 | Russia |
| Site Reference ID/Investigator# 50548 | Saint Petersburg | 194291 | Russia |
| Site Reference ID/Investigator# 50549 | Saint Petersburg | 195257 | Russia |
| Site Reference ID/Investigator# 50551 | Saint Petersburg | 196247 | Russia |
| Site Reference ID/Investigator# 50552 | Saint Petersburg | 199034 | Russia |
| Site Reference ID/Investigator# 50556 | Samara | 443067 | Russia |
| Site Reference ID/Investigator# 50555 | Saratov | 410028 | Russia |
| Site Reference ID/Investigator# 50554 | Stavropol | 355002 | Russia |
| Site Reference ID/Investigator# 50580 | Stavropol | 355030 | Russia |
| Site Reference ID/Investigator# 50579 | Tyumen | 625002 | Russia |
| Site Reference ID/Investigator# 50575 | Vladivostok | 690600 | Russia |
| Site Reference ID/Investigator# 50562 | Volzhskiy, Volgograd Region | 404130 | Russia |
| Site Reference ID/Investigator# 48866 | Voronezh | 394000 | Russia |
| Site Reference ID/Investigator# 54502 | Voronezh | 394006 | Russia |
| Site Reference ID/Investigator# 50563 | Yekaterinburg | 620026 | Russia |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Endometriosis location | Endometriosis is divided into genital and extra-genital by location. Genital endometriosis is internal endometriosis - adenomyosis (endometriosis of the uterus). Extra-genital endometriosis is external endometriosis (endometriosis of the uterine cervix, vagina, retro cervix area, ovaries, fallopian tubes, peritoneum, rectouterine space). | Number | participants |
| ||||||||||||||||||||||
| Time from endometriosis diagnosis | Mean | Standard Deviation | months |
| ||||||||||||||||||||||
| Severity of Endometriosis | Surgically, endometriosis can be staged I-IV (Revised Classification of the American Society of Reproductive Medicine) per the following: Stage I (Minimal): Findings restricted to only superficial lesions and possibly a few filmy adhesions; Stage II (Mild): In addition, some deep lesions are present in the cul-de-sac; Stage III (Moderate): As above, plus presence of endometriomas on the ovary and more adhesions; Stage IV (Severe): As above, plus large endometriomas, extensive adhesions. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment | 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. | Full Analysis Set included all all patients who had signed the personal authorization form and who administered at least one dose of leuprorelin and who had attended at least one post-baseline visit. | Posted | Number | percentage of participants | 6 months |
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| Secondary | Percent Compliance to Treatment With Leuprorelin | Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100. | Participants who received at least one dose of leuprorelin. | Posted | Mean | Standard Deviation | percent compliance | 6 months |
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| Secondary | Participants With Estrogen Deficiency Symptoms | Estrogen deficiency symptoms include:
| Full Analysis Set | Posted | Number | participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 390 | 0 | 390 |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbvie (prior sponsor, Abbott) | 800-633-9110 |
| Combined type |
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
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