Internal Endometriosis Clinical Trial
Official title:
A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis
| Verified date | July 2018 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To describe Gonadotropin-Releasing Hormone agonists (GnRH-a) treatment effectiveness on reduction of internal genital endometriosis symptom - menorrhagia - in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3,75 mg - assessment performed six months after the last injection.
| Status | Completed |
| Enrollment | 465 |
| Est. completion date | December 24, 2014 |
| Est. primary completion date | December 24, 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 25 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Premenopausal women aged 25-40 years old - With symptomatic internal genital endometriosis - at least mild menorrhagia present or worse - Internal genital endometriosis diagnosis is based on enlarged uterus detected by pelvic bimanual examination and ultrasound examination (stages I-II-III by Demidov in accordance with ultrasound results not earlier than 2 months before first injection - Naive patients who have never been prescribed a GnRH agonist Exclusion Criteria: - Pregnant subjects - Subjects with hypersensitivity to GnRH analogue or to one of its excipients - Subjects treated with any other investigational drug within the last 30 days before study entry - Subjects' refusal to participate in the study |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Moscow regional perinatal center | Balashikha | |
| Russian Federation | Scientific center of Family Health Problems and Human reproduction of Siberian branch of RAMS | Irkutsk | |
| Russian Federation | SEI Irkutsk State medical refresher institute | Irkutsk | |
| Russian Federation | Municipal healthcare institution "City hospital #11" | Kazan | |
| Russian Federation | City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center | Krasnodar | |
| Russian Federation | SHI "Regional clinical hospital #1 named after S. Ochapovskiy" | Krasnodar | |
| Russian Federation | Central Clinical Hospital of Civil aviation | Moscow | |
| Russian Federation | CM-Clinic | Moscow | |
| Russian Federation | FSBI "Research Center of Obstetrics, Gynecology and Perinatology named after V. Kulakov" on the base of City clinical hospital named after S. Botkin | Moscow | |
| Russian Federation | SHI "City Clinical Hospital #79" | Moscow | |
| Russian Federation | SI "Endocrinology Research Center" of the Ministry of Health and Social Development of the Russian Federation | Moscow | |
| Russian Federation | Treatment rehabilitation Center of Roszdrav | Moscow | |
| Russian Federation | FBHI "Volga regional medical center" of Federal Medical-Biological agency, gynecological department of clinical hospital #1 | Nizhny Novgorod | |
| Russian Federation | Non-governmental healthcare institution "Road clinical hospital on Gor'kiy station RZhD NChS | Nizhny Novgorod | |
| Russian Federation | Center of new medical technologies in academic town | Novosibirsk | |
| Russian Federation | Fertility Clinic | Novosibirsk | |
| Russian Federation | Medical Center Zdravitsa | Novosibirsk | |
| Russian Federation | Clinical hospital ?123 of FMBA of Russia | Odintsovo | |
| Russian Federation | Clinical hospital #1 of FSI "Southern federal district medical center" | Rostov-on-Don | |
| Russian Federation | FSI "Rostov Research institution of obstetrics and pediatry" | Rostov-on-Don | |
| Russian Federation | Rostov state medical university, department of obstetrics and gynaecology #3, based on SHI "Region hospital #2" | Rostov-on-Don | |
| Russian Federation | SHI "City hospital #8" | Rostov-on-Don | |
| Russian Federation | SHI "Regional hospital #2" | Rostov-on-Don | |
| Russian Federation | City hospital #3 of the Holy Reverend Martyr Elizabeth | Saint Petersburg | |
| Russian Federation | North-West State Medical University named after I. Mechnikov on the base of maternity hospital #17 | Saint Petersburg | |
| Russian Federation | Scientific-Research Institute of obstetrics and gynecology named after D.O. Otto of Russian Academy of Medical Science | Saint Petersburg | |
| Russian Federation | Medical centre IDK | Samara | |
| Russian Federation | Non-governmental healthcare institution " Railway Clinical Hospital" | Saratov | |
| Russian Federation | SHI "Regional Clinical Hospital" | Saratov | |
| Russian Federation | SHI Saratov Regional Centre of Family Planning and Reproduction | Saratov | |
| Russian Federation | Non-governmental healthcare institution "Departmental clinical hospital on station Ufa RZHD" | Ufa | |
| Russian Federation | Federal State-Funded Educational Institution of Higher Vocational Education "Volgogradskii State Medical University of Roszdrav on the base of Hospital #1 | Volgograd | |
| Russian Federation | Medical center "Yunona" | Yaroslavl | |
| Russian Federation | Municipal clinical healthcare Institution of Yaroslavl region "Primary healthcare unit NYa ORP" | Yaroslavl |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Severity of disease symptom menorrhagia (none-mild-moderate-severe) in different disease stages I, II, III in the Russian subject population scheduled for treatment with Diphereline 3.75 mg | A responder is defined as a subject with menorrhagia reduction at least by one level (i.e. from severe to moderate, from moderate to mild, from mild to none). | Change from baseline to up to 6 months after the last injection (up to month 11) | |
| Secondary | Patients' age at study entry | Baseline (Day 1) | ||
| Secondary | Age at the time of internal genital endometriosis diagnosis | Baseline (Day 1) | ||
| Secondary | Gynaecological history | Age of menarche, hereditary load in onco-gynaecology, sexually transmitted infections, gynaecological surgical procedures, number of pregnancies, medical abortions, miscarriages, normal deliveries, coexisting gynaecological diseases, somatic diseases, if any. | Baseline (Day 1) | |
| Secondary | Data on fertility: primary and secondary sterility | Baseline (Day 1) | ||
| Secondary | Medical history | Baseline (Day 1) | ||
| Secondary | Concomitant medications and non drug therapy for internal endometriosis treatment | Baseline (Day 1) | ||
| Secondary | Severity of disease symptom dysmenorrhea (none-mild-moderate-severe) in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | A full responder is defined as the person with a reduction of intensity of at least one level for all symptoms of at least mild intensity at baseline (i.e. from severe to moderate, from moderate to mild, from mild to none). | On the day of the last injection (up to Month 5) | |
| Secondary | Severity of disease symptom menorrhagia (none-mild-moderate-severe) in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | A full responder is defined as the person with a reduction of intensity of at least one level for all symptoms of at least mild intensity at baseline (i.e. from severe to moderate, from moderate to mild, from mild to none). | On the day of the last injection (up to Month 5) | |
| Secondary | Severity of disease symptom metrorrhagia (none-mild-moderate-severe) | A full responder is defined as the person with a reduction of intensity of at least one level for all symptoms of at least mild intensity at baseline (i.e. from severe to moderate, from moderate to mild, from mild to none). | On the day of the last injection (up to Month 5) | |
| Secondary | Severity of disease symptom pelvic pain (none-mild-moderate-severe) in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | A full responder is defined as the person with a reduction of intensity of at least one level for all symptoms of at least mild intensity at baseline (i.e. from severe to moderate, from moderate to mild, from mild to none). | On the day of the last injection (up to Month 5) | |
| Secondary | Uterine volume in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | Measured by ultrasound and calculated by the equation 0,523 x a x b x c, where a, b and c stand for uterine length, width and thickness, respectively | Baseline (Day 1) and on the day of the last injection (up to Month 5) | |
| Secondary | Uterine shape (bimanual pelvic examination) in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | Baseline (Day 1) and on the day of the last injection (up to Month 5) | ||
| Secondary | Internal genital endometriosis symptom metrorrhagia in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | Change from baseline (Day 1) to 6 months after the last injection (up to Month 11) | ||
| Secondary | Internal genital endometriosis symptom dysmenorrhea in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | Change from baseline (Day 1) to 6 months after the last injection (up to Month 11) | ||
| Secondary | Internal genital endometriosis symptom pelvic pain in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg | Change from baseline (Day 1) to 6 months after the last injection (up to Month 11) | ||
| Secondary | Reproduction function will be assessed by the number of patients got pregnant 6 and 9 months after the end of treatment with Diphereline 3.75mg | 6 and 9 months after the end of treatment with Diphereline | ||
| Secondary | Reproduction function will be assessed by the number of patients who avoided hysterectomy/ did not receive a surgical treatment 6 and 9 months after the end of treatment with Diphereline 3.75mg | 6 and 9 months after the end of treatment with Diphereline | ||
| Secondary | Diphereline 3.75 mg treatment practice will be assessed by the number of scheduled/ performed injections with treatment schedule (each 28 days) in line with treatment administration approved in Russian Federation | Up to Month 5 | ||
| Secondary | Diphereline 3.75 mg treatment practice will be assessed by patient compliance with treatment schedule (each 28 days) in line with treatment administration approved in Russian Federation | Up to Month 5 |