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Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis

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ClinicalTrials.gov Identifier: NCT03586063
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Internal Endometriosis Other: Data collection

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Study Type : Observational
Actual Enrollment : 465 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis
Actual Study Start Date : November 3, 2011
Actual Primary Completion Date : December 24, 2014
Actual Study Completion Date : December 24, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis


Intervention Details:
  • Other: 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.



Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. Patients' age at study entry [ Time Frame: Baseline (Day 1) ]
  2. Age at the time of internal genital endometriosis diagnosis [ Time Frame: Baseline (Day 1) ]
  3. Gynaecological history [ Time Frame: 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.

  4. Data on fertility: primary and secondary sterility [ Time Frame: Baseline (Day 1) ]
  5. Medical history [ Time Frame: Baseline (Day 1) ]
  6. Concomitant medications and non drug therapy for internal endometriosis treatment [ Time Frame: Baseline (Day 1) ]
  7. 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 [ Time Frame: 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).

  8. 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 [ Time Frame: 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).

  9. Severity of disease symptom metrorrhagia (none-mild-moderate-severe) [ Time Frame: 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).

  10. 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 [ Time Frame: 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).

  11. Uterine volume in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3.75 mg [ Time Frame: 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

  12. 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 [ Time Frame: Baseline (Day 1) and on the day of the last injection (up to Month 5) ]
  13. 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 [ Time Frame: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11) ]
  14. 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 [ Time Frame: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11) ]
  15. 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 [ Time Frame: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11) ]
  16. 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 [ Time Frame: 6 and 9 months after the end of treatment with Diphereline ]
  17. 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 [ Time Frame: 6 and 9 months after the end of treatment with Diphereline ]
  18. 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 [ Time Frame: Up to Month 5 ]
  19. 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 [ Time Frame: Up to Month 5 ]


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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Antenatal clinics and Medical centres
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586063


Locations
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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, 664003
SEI Irkutsk State medical refresher institute
Irkutsk, Russian Federation, 664011
Municipal healthcare institution "City hospital #11"
Kazan, Russian Federation, 420127
City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center
Krasnodar, Russian Federation, 350012
SHI "Regional clinical hospital #1 named after S. Ochapovskiy"
Krasnodar, Russian Federation, 350029
SHI "City Clinical Hospital #79"
Moscow, Russian Federation, 115487
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, 125284
Treatment rehabilitation Center of Roszdrav
Moscow, Russian Federation, 125367
Central Clinical Hospital of Civil aviation
Moscow, Russian Federation
CM-Clinic
Moscow, Russian Federation
SI "Endocrinology Research Center" of the Ministry of Health and Social Development of the Russian Federation
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, 630090
Medical Center Zdravitsa
Novosibirsk, Russian Federation, 630091
Fertility Clinic
Novosibirsk, Russian Federation
Clinical hospital №123 of FMBA of Russia
Odintsovo, Russian Federation
SHI "City hospital #8"
Rostov-on-Don, Russian Federation, 344000
Clinical hospital #1 of FSI "Southern federal district medical center"
Rostov-on-Don, Russian Federation, 344023
Rostov state medical university, department of obstetrics and gynaecology #3, based on SHI "Region hospital #2"
Rostov-on-Don, Russian Federation, 344029
SHI "Regional hospital #2"
Rostov-on-Don, Russian Federation, 344029
FSI "Rostov Research institution of obstetrics and pediatry"
Rostov-on-Don, Russian Federation, 350029
City hospital #3 of the Holy Reverend Martyr Elizabeth
Saint Petersburg, Russian Federation, 195257
North-West State Medical University named after I. Mechnikov on the base of maternity hospital #17
Saint Petersburg, Russian Federation, 195257
Scientific-Research Institute of obstetrics and gynecology named after D.O. Otto of Russian Academy of Medical Science
Saint Petersburg, Russian Federation, 199034
Medical centre IDK
Samara, Russian Federation, 443067
Non-governmental healthcare institution " Railway Clinical Hospital"
Saratov, Russian Federation, 410004
SHI "Regional Clinical Hospital"
Saratov, Russian Federation, 410053
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, 450054
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, 150000
Municipal clinical healthcare Institution of Yaroslavl region "Primary healthcare unit NYa ORP"
Yaroslavl, Russian Federation, 150023
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Study Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03586063     History of Changes
Other Study ID Numbers: A-38-52014-191
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Genital Diseases, Female
Uterine Diseases