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)
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| ClinicalTrials.gov Identifier: NCT01294371 |
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Recruitment Status :
Completed
First Posted : February 11, 2011
Results First Posted : July 22, 2013
Last Update Posted : July 22, 2013
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| Condition or disease |
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| Genital Endometriosis |
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 |
| Actual Enrollment : | 391 participants |
| Time Perspective: | Prospective |
| Official Title: | 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. |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
| Group/Cohort |
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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. |
- 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.
- 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.
- Participants With Estrogen Deficiency Symptoms [ Time Frame: 6 months ]
Estrogen deficiency symptoms include:
- hot flashes,
- headaches,
- palpitations at rest,
- insomnia,
- fluctuation of mood.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294371
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| Study Director: | Andrey Strugovshchikov, MD | AbbVie |
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01294371 |
| Other Study ID Numbers: |
P12-762 |
| First Posted: | February 11, 2011 Key Record Dates |
| Results First Posted: | July 22, 2013 |
| Last Update Posted: | July 22, 2013 |
| Last Verified: | May 2013 |
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Lucrin Depot genital endometriosis 6 months therapy |
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Endometriosis |