A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis

Brief Summary

Primary Outcomes

Secondary Outcomes

• Patients' age at study entry(Baseline (Day 1))
• Gynaecological history(Baseline (Day 1))
• 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))
• 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)
• Age at the time of internal genital endometriosis diagnosis(Baseline (Day 1))
• Concomitant medications and non drug therapy for internal endometriosis treatment(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(On the day of the last injection (up to Month 5))
• 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)
• Medical history(Baseline (Day 1))
• 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))
• 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))
• 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 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))
• 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)
• 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))
• Severity of disease symptom metrorrhagia (none-mild-moderate-severe)(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(On the day of the last injection (up to Month 5))
• 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)