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

Completed

• Conditions: Internal Endometriosis

• Registration Number: NCT03586063
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-03
• Primary Completion: 2014-12-24
• Study Completion: 2014-12-24
• Study First Submitted: 2018-06-08
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-13
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 465

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patients' age at study entry	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.
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)	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).
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
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).
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
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)	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).
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
Medical history	Baseline (Day 1)

Trial Locations

Locations (34)

Moscow regional perinatal center; 🇷🇺 Balashikha, Russian Federation

Scientific center of Family Health Problems and Human reproduction of Siberian branch of RAMS; 🇷🇺 Irkutsk, Russian Federation

SEI Irkutsk State medical refresher institute; 🇷🇺 Irkutsk, Russian Federation

Municipal healthcare institution "City hospital #11"; 🇷🇺 Kazan, Russian Federation

City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center; 🇷🇺 Krasnodar, Russian Federation

SHI "Regional clinical hospital #1 named after S. Ochapovskiy"; 🇷🇺 Krasnodar, Russian Federation

SHI "City Clinical Hospital #79"; 🇷🇺 Moscow, Russian Federation

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

Treatment rehabilitation Center of Roszdrav; 🇷🇺 Moscow, Russian Federation

Central Clinical Hospital of Civil aviation; 🇷🇺 Moscow, Russian Federation

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