Clinical trial NCT03586063: Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis
Official title: A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internal Endometriosis
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 465
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Antenatal clinics and Medical centres

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Change from baseline to up to 6 months after the last injection (up to month 11)
Secondary outcomes:
measure: Patients' age at study entry
timeFrame: Baseline (Day 1)
measure: Age at the time of internal genital endometriosis diagnosis
timeFrame: Baseline (Day 1)
measure: Gynaecological history
timeFrame: Baseline (Day 1)
measure: Data on fertility: primary and secondary sterility
timeFrame: Baseline (Day 1)
measure: Medical history
timeFrame: Baseline (Day 1)
measure: Concomitant medications and non drug therapy for internal endometriosis treatment
timeFrame: Baseline (Day 1)
measure: 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
timeFrame: On the day of the last injection (up to Month 5)
measure: 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
timeFrame: On the day of the last injection (up to Month 5)
measure: Severity of disease symptom metrorrhagia (none-mild-moderate-severe)
timeFrame: On the day of the last injection (up to Month 5)
measure: 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
timeFrame: On the day of the last injection (up to Month 5)
measure: Uterine volume in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg
timeFrame: Baseline (Day 1) and on the day of the last injection (up to Month 5)
measure: 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
timeFrame: Baseline (Day 1) and on the day of the last injection (up to Month 5)
measure: 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
timeFrame: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11)
measure: 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
timeFrame: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11)
measure: 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
timeFrame: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11)
measure: 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
timeFrame: 6 and 9 months after the end of treatment with Diphereline
measure: 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
timeFrame: 6 and 9 months after the end of treatment with Diphereline
measure: 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
timeFrame: Up to Month 5
measure: 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
timeFrame: Up to Month 5
Other outcomes:
Locations:
city: Balashikha
country: Russian Federation
facility: Moscow regional perinatal center
city: Irkutsk
country: Russian Federation
facility: Scientific center of Family Health Problems and Human reproduction of Siberian branch of RAMS
city: Irkutsk
country: Russian Federation
facility: SEI Irkutsk State medical refresher institute
city: Kazan
country: Russian Federation
facility: Municipal healthcare institution "City hospital #11"
city: Krasnodar
country: Russian Federation
facility: City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center
city: Krasnodar
country: Russian Federation
facility: SHI "Regional clinical hospital #1 named after S. Ochapovskiy"
city: Moscow
country: Russian Federation
facility: SHI "City Clinical Hospital #79"
city: Moscow
country: Russian Federation
facility: FSBI "Research Center of Obstetrics, Gynecology and Perinatology named after V. Kulakov" on the base of City clinical hospital named after S. Botkin
city: Moscow
country: Russian Federation
facility: Treatment rehabilitation Center of Roszdrav
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Civil aviation
city: Moscow
country: Russian Federation
facility: CM-Clinic
city: Moscow
country: Russian Federation
facility: SI "Endocrinology Research Center" of the Ministry of Health and Social Development of the Russian Federation
city: Nizhny Novgorod
country: Russian Federation
facility: FBHI "Volga regional medical center" of Federal Medical-Biological agency, gynecological department of clinical hospital #1
city: Nizhny Novgorod
country: Russian Federation
facility: Non-governmental healthcare institution "Road clinical hospital on Gor'kiy station RZhD NChS
city: Novosibirsk
country: Russian Federation
facility: Center of new medical technologies in academic town
city: Novosibirsk
country: Russian Federation
facility: Medical Center Zdravitsa
city: Novosibirsk
country: Russian Federation
facility: Fertility Clinic
city: Odintsovo
country: Russian Federation
facility: Clinical hospital №123 of FMBA of Russia
city: Rostov-on-Don
country: Russian Federation
facility: SHI "City hospital #8"
city: Rostov-on-Don
country: Russian Federation
facility: Clinical hospital #1 of FSI "Southern federal district medical center"
city: Rostov-on-Don
country: Russian Federation
facility: Rostov state medical university, department of obstetrics and gynaecology #3, based on SHI "Region hospital #2"
city: Rostov-on-Don
country: Russian Federation
facility: SHI "Regional hospital #2"
city: Rostov-on-Don
country: Russian Federation
facility: FSI "Rostov Research institution of obstetrics and pediatry"
city: Saint Petersburg
country: Russian Federation
facility: City hospital #3 of the Holy Reverend Martyr Elizabeth
city: Saint Petersburg
country: Russian Federation
facility: North-West State Medical University named after I. Mechnikov on the base of maternity hospital #17
city: Saint Petersburg
country: Russian Federation
facility: Scientific-Research Institute of obstetrics and gynecology named after D.O. Otto of Russian Academy of Medical Science
city: Samara
country: Russian Federation
facility: Medical centre IDK
city: Saratov
country: Russian Federation
facility: Non-governmental healthcare institution " Railway Clinical Hospital"
city: Saratov
country: Russian Federation
facility: SHI "Regional Clinical Hospital"
city: Saratov
country: Russian Federation
facility: SHI Saratov Regional Centre of Family Planning and Reproduction
city: Ufa
country: Russian Federation
facility: Non-governmental healthcare institution "Departmental clinical hospital on station Ufa RZHD"
city: Volgograd
country: Russian Federation
facility: Federal State-Funded Educational Institution of Higher Vocational Education "Volgogradskii State Medical University of Roszdrav on the base of Hospital #1
city: Yaroslavl
country: Russian Federation
facility: Medical center "Yunona"
city: Yaroslavl
country: Russian Federation
facility: Municipal clinical healthcare Institution of Yaroslavl region "Primary healthcare unit NYa ORP"
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References: