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

Ipsen465 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

465

Conditions

Internal Endometriosis

Interventions

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.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

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).

Time frame: Change from baseline to up to 6 months after the last injection (up to month 11)

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

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.

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

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 from ClinicalTrials.gov

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Moscow regional perinatal center

Balashikha, Russia

Scientific center of Family Health Problems and Human reproduction of Siberian branch of RAMS

Irkutsk, Russia

SEI Irkutsk State medical refresher institute

Irkutsk, Russia

Municipal healthcare institution "City hospital #11"

Kazan', Russia

City hospital #2, Krasnodar multi-field medical diagnostic association, endoscopic gynecology center

Krasnodar, Russia

SHI "Regional clinical hospital #1 named after S. Ochapovskiy"

Krasnodar, Russia

SHI "City Clinical Hospital #79"

Moscow, Russia

FSBI "Research Center of Obstetrics, Gynecology and Perinatology named after V. Kulakov" on the base of City clinical hospital named after S. Botkin

Moscow, Russia

Treatment rehabilitation Center of Roszdrav

Moscow, Russia

Central Clinical Hospital of Civil aviation

Moscow, Russia

...and 24 more locations

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

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

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