Internal Endometriosis
Conditions
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.
Interventions
OTHERData 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.
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Medical history | Baseline (Day 1) | — |
| Concomitant medications and non drug therapy for internal endometriosis treatment | Baseline (Day 1) | — |
| Patients' age at study entry | Baseline (Day 1) | — |
| Age at the time of internal genital endometriosis diagnosis | 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. |
| 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). |
| 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). |
| 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). |
| 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) | — |
| 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 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) | — |
| 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) | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 |
Countries
Russia
Outcome results
None listed