Internal EndometriosisNCT03586063
Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis
An observational study of Internal Endometriosis, run by Ipsen at 34 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Internal Endometriosis
- What is being tested?
- Data collection
- Type of treatment
- Injection or infusion
- How many people
- 465 participants
- Where
- 34 sitesRussia
- Study dates
- 3 Nov 2011to 24 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Antenatal clinics and Medical centres
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Russia34 sites
Moscow regional perinatal center
Balashikha
Scientific center of Family Health Problems and Human reproduction of Siberian branch of RAMS
Irkutsk, 664003
SEI Irkutsk State medical refresher institute
Irkutsk, 664011
Municipal healthcare institution "City hospital #11"
Kazan', 420127
City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center
Krasnodar, 350012
SHI "Regional clinical hospital #1 named after S. Ochapovskiy"
Krasnodar, 350029
SHI "City Clinical Hospital #79"
Moscow, 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, 125284
Treatment rehabilitation Center of Roszdrav
Moscow, 125367
Central Clinical Hospital of Civil aviation
Moscow
CM-Clinic
Moscow
SI "Endocrinology Research Center" of the Ministry of Health and Social Development of the Russian Federation
Moscow
FBHI "Volga regional medical center" of Federal Medical-Biological agency, gynecological department of clinical hospital #1
Nizhny Novgorod
Non-governmental healthcare institution "Road clinical hospital on Gor'kiy station RZhD NChS
Nizhny Novgorod
Center of new medical technologies in academic town
Novosibirsk, 630090
Medical Center Zdravitsa
Novosibirsk, 630091
Fertility Clinic
Novosibirsk
Clinical hospital №123 of FMBA of Russia
Odintsovo
SHI "City hospital #8"
Rostov-on-Don, 344000
Clinical hospital #1 of FSI "Southern federal district medical center"
Rostov-on-Don, 344023
Rostov state medical university, department of obstetrics and gynaecology #3, based on SHI "Region hospital #2"
Rostov-on-Don, 344029
SHI "Regional hospital #2"
Rostov-on-Don, 344029
FSI "Rostov Research institution of obstetrics and pediatry"
Rostov-on-Don, 350029
City hospital #3 of the Holy Reverend Martyr Elizabeth
Saint Petersburg, 195257
North-West State Medical University named after I. Mechnikov on the base of maternity hospital #17
Saint Petersburg, 195257
Scientific-Research Institute of obstetrics and gynecology named after D.O. Otto of Russian Academy of Medical Science
Saint Petersburg, 199034
Medical centre IDK
Samara, 443067
Non-governmental healthcare institution " Railway Clinical Hospital"
Saratov, 410004
SHI "Regional Clinical Hospital"
Saratov, 410053
SHI Saratov Regional Centre of Family Planning and Reproduction
Saratov
Non-governmental healthcare institution "Departmental clinical hospital on station Ufa RZHD"
Ufa, 450054
Federal State-Funded Educational Institution of Higher Vocational Education "Volgogradskii State Medical University of Roszdrav on the base of Hospital #1
Volgograd
Medical center "Yunona"
Yaroslavl, 150000
Municipal clinical healthcare Institution of Yaroslavl region "Primary healthcare unit NYa ORP"
Yaroslavl, 150023
About this study
Official title: A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis
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.
- Conditions
- Internal Endometriosis
- Being tested
- Data collection
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to up to 6 months after the last injection (up to month 11)
Secondary outcomes (19)
Patients' age at study entry
Measured: Baseline (Day 1)
Age at the time of internal genital endometriosis diagnosis
Measured: Baseline (Day 1)
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.
Measured: Baseline (Day 1)
Data on fertility: primary and secondary sterility
Measured: Baseline (Day 1)
Medical history
Measured: Baseline (Day 1)
Concomitant medications and non drug therapy for internal endometriosis treatment
Measured: 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
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).
Measured: On the day of the last injection (up to Month 5)
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).
Measured: On the day of the last injection (up to Month 5)
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).
Measured: On the day of the last injection (up to Month 5)
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).
Measured: On the day of the last injection (up to Month 5)
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
Measured: Baseline (Day 1) and on the day of the last injection (up to Month 5)
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
Measured: Baseline (Day 1) and on the day of the last injection (up to Month 5)
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
Measured: Change from baseline (Day 1) to 6 months after the last injection (up to Month 11)
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
Measured: 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
Measured: 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 got pregnant 6 and 9 months after the end of treatment with Diphereline 3.75mg
Measured: 6 and 9 months after the end of treatment with Diphereline
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
Measured: 6 and 9 months after the end of treatment with Diphereline
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
Measured: Up to Month 5
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
Measured: Up to Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start3 Nov 2011
- Primary completion24 Dec 2014
- Study completion24 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal EndometriosisStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586063
- Sponsor's protocol ID
- A-38-52014-191
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis
- ClinicalTrials.gov ID
- NCT03586063
- Acronym / sponsor ID
- A-38-52014-191
- Conditions
- Internal Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2011 (actual)
- Primary completion
- 24 Dec 2014 (actual)
- Study completion
- 24 Dec 2014 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Antenatal clinics and Medical centres
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThis 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. | Other | – |
Primary outcome
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).
19 secondary outcomes
Patients' age at study entry
Time frame: Baseline (Day 1)
Age at the time of internal genital endometriosis diagnosis
Time frame: Baseline (Day 1)
Gynaecological history
Time frame: Baseline (Day 1)
Data on fertility: primary and secondary sterility
Time frame: Baseline (Day 1)
Medical history
Time frame: Baseline (Day 1)
Concomitant medications and non drug therapy for internal endometriosis treatment
Time frame: 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
Time frame: On the day of the last injection (up to Month 5)
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)
Severity of disease symptom metrorrhagia (none-mild-moderate-severe)
Time frame: On the day of the last injection (up to Month 5)
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)
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)
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)
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)
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)
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)
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Study Director study director
Ipsen
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Endometriosis, run by Ipsen at 34 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Change from baseline to up to 6 months after the last injection (up to month 11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.