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Completed

NCT Number: NCT03586063

Study of Diphereline 3.75 mg Treatment In 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.

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Key information

Conditions

Internal Endometriosis Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Moscow regional perinatal center, Balashikha, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Patients' age at study entry

    Time frame: Baseline (Day 1)

  2. Age at the time of internal genital endometriosis diagnosis

    Time frame: Baseline (Day 1)

  3. Gynaecological history

    Time frame: 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.

  4. Data on fertility: primary and secondary sterility

    Time frame: Baseline (Day 1)

  5. Medical history

    Time frame: Baseline (Day 1)

  6. Concomitant medications and non drug therapy for internal endometriosis treatment

    Time frame: Baseline (Day 1)

  7. 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)

    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).

  8. 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)

    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).

  9. Severity of disease symptom metrorrhagia (none-mild-moderate-severe)

    Time frame: 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).

  10. 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)

    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).

  11. 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)

    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

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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

  17. 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

  18. 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

  19. 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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 13, 2018
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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