Genital Endometriosis Clinical Trial
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.
| Verified date | May 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Russia: Ministry of Health of the Russian Federation |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 391 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Site Reference ID/Investigator# 51643 | Chelyabinsk | |
| Russian Federation | Site Reference ID/Investigator# 50563 | Ekaterinburg | |
| Russian Federation | Site Reference ID/Investigator# 50577 | Irkutsk | |
| Russian Federation | Site Reference ID/Investigator# 50561 | Izhevsk | |
| Russian Federation | Site Reference ID/Investigator# 50560 | Kazan | |
| Russian Federation | Site Reference ID/Investigator# 50564 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 50565 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 50567 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 50570 | Moscow | |
| Russian Federation | Site Reference ID/Investigator# 62184 | Nizhniy Novgorod | |
| Russian Federation | Site Reference ID/Investigator# 50558 | Nizhny Novgorod | |
| Russian Federation | Site Reference ID/Investigator# 50557 | Orenburg | |
| Russian Federation | Site Reference ID/Investigator# 50545 | Perm | |
| Russian Federation | Site Reference ID/Investigator# 53156 | Perm | |
| Russian Federation | Site Reference ID/Investigator# 50556 | Samara | |
| Russian Federation | Site Reference ID/Investigator# 50555 | Saratov | |
| Russian Federation | Site Reference ID/Investigator# 50547 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 50548 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 50549 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 50551 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 50552 | St. Petersburg | |
| Russian Federation | Site Reference ID/Investigator# 50554 | Stavropol | |
| Russian Federation | Site Reference ID/Investigator# 50580 | Stavropol | |
| Russian Federation | Site Reference ID/Investigator# 50579 | Tumen | |
| Russian Federation | Site Reference ID/Investigator# 50575 | Vladivostok | |
| Russian Federation | Site Reference ID/Investigator# 50562 | Volzhskiy, Volgograd Region | |
| Russian Federation | Site Reference ID/Investigator# 48866 | Voronezh | |
| Russian Federation | Site Reference ID/Investigator# 54502 | Voronezh |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) | Almedis |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 6 months | No |
| Secondary | 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 | No |
| Secondary | Participants With Estrogen Deficiency Symptoms | Estrogen deficiency symptoms include: hot flashes, headaches, palpitations at rest, insomnia, fluctuation of mood. |
6 months | Yes |