Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis
- Conditions
- Internal Endometriosis
- Registration Number
- NCT03586063
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 465
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Change from baseline to up to 6 months after the last injection (up to month 11) 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).
- Secondary Outcome Measures
Name Time Method Patients' age at study entry Baseline (Day 1) Gynaecological history Baseline (Day 1) 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.
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) 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 Age at the time of internal genital endometriosis diagnosis Baseline (Day 1) Concomitant medications and non drug therapy for internal endometriosis treatment Baseline (Day 1) 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 On the day of the last injection (up to Month 5) 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).
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 Medical history Baseline (Day 1) 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 On the day of the last injection (up to Month 5) 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).
Uterine volume 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) 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
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) 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) 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 Data on fertility: primary and secondary sterility Baseline (Day 1) 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) Severity of disease symptom metrorrhagia (none-mild-moderate-severe) On the day of the last injection (up to Month 5) 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).
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 On the day of the last injection (up to Month 5) 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).
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
Trial Locations
- Locations (34)
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
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
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 "Regional Clinical Hospital"
🇷🇺Saratov, Russian Federation
Treatment rehabilitation Center of Roszdrav
🇷🇺Moscow, Russian Federation
Non-governmental healthcare institution "Road clinical hospital on Gor'kiy station RZhD NChS
🇷🇺Nizhny Novgorod, Russian Federation
City hospital #3 of the Holy Reverend Martyr Elizabeth
🇷🇺Saint Petersburg, Russian Federation
Medical center "Yunona"
🇷🇺Yaroslavl, Russian Federation
Fertility Clinic
🇷🇺Novosibirsk, Russian Federation
SHI "Regional hospital #2"
🇷🇺Rostov-on-Don, Russian Federation
Scientific-Research Institute of obstetrics and gynecology named after D.O. Otto of Russian Academy of Medical Science
🇷🇺Saint Petersburg, Russian Federation
SHI Saratov Regional Centre of Family Planning and Reproduction
🇷🇺Saratov, Russian Federation
Rostov state medical university, department of obstetrics and gynaecology #3, based on SHI "Region hospital #2"
🇷🇺Rostov-on-Don, Russian Federation
Non-governmental healthcare institution " Railway Clinical Hospital"
🇷🇺Saratov, Russian Federation
Medical centre IDK
🇷🇺Samara, Russian Federation
Non-governmental healthcare institution "Departmental clinical hospital on station Ufa RZHD"
🇷🇺Ufa, Russian Federation
Municipal clinical healthcare Institution of Yaroslavl region "Primary healthcare unit NYa ORP"
🇷🇺Yaroslavl, Russian Federation
Moscow regional perinatal center
🇷🇺Balashikha, Russian Federation
Central Clinical Hospital of Civil aviation
🇷🇺Moscow, Russian Federation
Municipal healthcare institution "City hospital #11"
🇷🇺Kazan, Russian Federation
Center of new medical technologies in academic town
🇷🇺Novosibirsk, Russian Federation
Medical Center Zdravitsa
🇷🇺Novosibirsk, Russian Federation
SHI "City Clinical Hospital #79"
🇷🇺Moscow, Russian Federation
Clinical hospital â„–123 of FMBA of Russia
🇷🇺Odintsovo, Russian Federation
North-West State Medical University named after I. Mechnikov on the base of maternity hospital #17
🇷🇺Saint Petersburg, 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
SI "Endocrinology Research Center" of the Ministry of Health and Social Development of the Russian Federation
🇷🇺Moscow, Russian Federation
CM-Clinic
🇷🇺Moscow, Russian Federation
FBHI "Volga regional medical center" of Federal Medical-Biological agency, gynecological department of clinical hospital #1
🇷🇺Nizhny Novgorod, Russian Federation
SHI "City hospital #8"
🇷🇺Rostov-on-Don, 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