Diphereline Post Marketing Surveillance Study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Open, non-comparative, multi-center, phase IV study

Study drug and medical condition

• Name of medicine, other:
  Diphereline 3.75mg
• Study drug International non-proprietary name (INN) or common name:
  TRIPTORELIN
• Anatomical Therapeutic Chemical (ATC) code:
  (L02AE04) triptorelin

  triptorelin
• Medical condition to be studied:
  Endometriosis
• Additional medical condition(s):
  Fibromyoma

Population studied

• Short description of the study population:
  Inclusion criteria:; • Patients who suffer from Endometriosis or Fibromyoma; • Patients who need GnRH agonist after laparoscopy diagnosis of Endometriosis; • Patients who need GnRH agonist to facilitate or modify a Fibromyoma related surgical technique; Exclusion criteria:; • Pregnant or breast-feeding women; • Hypersensitivity to GnRH analogues or to one of its excipients; • Patients who were recently (< 6 months) administered triptorelin or another GnRH analogue
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  245

Study design details

• Main study objective:
  The objective of the study was to assess the safety and efficacy of Diphereline 3.75 mg in gynaecology use such as Endometriosis and Fibromyoma
• Outcomes:
  Efficacy assessment: physical examination and symptoms report, hormonal responses, overall evaluation according to the criteria from 1-notably improved until 5 worsened and 6 not available. Safety assessment: AEs
• Data analysis plan:
  The proportions of patients with all levels of improvement were determined. All proportions were presented with a corresponding 95% confidence interval. Safety was evaluated in relation to the number of AE events and the number of cases with abnormal results in relevant laboratory tests.

Documents

Study results

a3852014118-synopsis_Redacted