Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis
NCT ID: NCT03586063
Last Updated: 2018-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
465 participants
OBSERVATIONAL
2011-11-03
2014-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Data collection
This is a non-interventional (observational) national multicentre prospective study.
Treatment was administered according to the Summary of Product Characteristics (SmPC): maximum 6 injections administered every 28 days.
The decision to prescribe GnRH-a (Diphereline 3,75 mg) was made prior to and independently from the decision to enroll the patient into the study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
40 Years
FEMALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Moscow regional perinatal center
Balashikha, , Russia
Scientific center of Family Health Problems and Human reproduction of Siberian branch of RAMS
Irkutsk, , Russia
SEI Irkutsk State medical refresher institute
Irkutsk, , Russia
Municipal healthcare institution "City hospital #11"
Kazan', , Russia
City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center
Krasnodar, , Russia
SHI "Regional clinical hospital #1 named after S. Ochapovskiy"
Krasnodar, , Russia
SHI "City Clinical Hospital #79"
Moscow, , Russia
FSBI "Research Center of Obstetrics, Gynecology and Perinatology named after V. Kulakov" on the base of City clinical hospital named after S. Botkin
Moscow, , Russia
Treatment rehabilitation Center of Roszdrav
Moscow, , Russia
Central Clinical Hospital of Civil aviation
Moscow, , Russia
CM-Clinic
Moscow, , Russia
SI "Endocrinology Research Center" of the Ministry of Health and Social Development of the Russian Federation
Moscow, , Russia
FBHI "Volga regional medical center" of Federal Medical-Biological agency, gynecological department of clinical hospital #1
Nizhny Novgorod, , Russia
Non-governmental healthcare institution "Road clinical hospital on Gor'kiy station RZhD NChS
Nizhny Novgorod, , Russia
Center of new medical technologies in academic town
Novosibirsk, , Russia
Medical Center Zdravitsa
Novosibirsk, , Russia
Fertility Clinic
Novosibirsk, , Russia
Clinical hospital №123 of FMBA of Russia
Odintsovo, , Russia
SHI "City hospital #8"
Rostov-on-Don, , Russia
Clinical hospital #1 of FSI "Southern federal district medical center"
Rostov-on-Don, , Russia
Rostov state medical university, department of obstetrics and gynaecology #3, based on SHI "Region hospital #2"
Rostov-on-Don, , Russia
SHI "Regional hospital #2"
Rostov-on-Don, , Russia
FSI "Rostov Research institution of obstetrics and pediatry"
Rostov-on-Don, , Russia
City hospital #3 of the Holy Reverend Martyr Elizabeth
Saint Petersburg, , Russia
North-West State Medical University named after I. Mechnikov on the base of maternity hospital #17
Saint Petersburg, , Russia
Scientific-Research Institute of obstetrics and gynecology named after D.O. Otto of Russian Academy of Medical Science
Saint Petersburg, , Russia
Medical centre IDK
Samara, , Russia
Non-governmental healthcare institution " Railway Clinical Hospital"
Saratov, , Russia
SHI "Regional Clinical Hospital"
Saratov, , Russia
SHI Saratov Regional Centre of Family Planning and Reproduction
Saratov, , Russia
Non-governmental healthcare institution "Departmental clinical hospital on station Ufa RZHD"
Ufa, , Russia
Federal State-Funded Educational Institution of Higher Vocational Education "Volgogradskii State Medical University of Roszdrav on the base of Hospital #1
Volgograd, , Russia
Medical center "Yunona"
Yaroslavl, , Russia
Municipal clinical healthcare Institution of Yaroslavl region "Primary healthcare unit NYa ORP"
Yaroslavl, , Russia
Countries
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Other Identifiers
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A-38-52014-191
Identifier Type: -
Identifier Source: org_study_id
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