Endometriosis-associated pelvic pain MedDRA version: 9.1 Level: LLT Classification code 10014778 Term: Endometriosis
Conditions
Interventions
Trade Name: ENANTONE*IM SC FL+SIR 11,25MG/
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Leuprorelin
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Age between 30 and 45 years old 2)Caucasian 3)Diagnosis of endometriosis associated chronic pelvic pain made by a ginecologist at the Endometriosis Center in S. Chiara Hospital. The endometriosis diagnosis confirmation include specific bioptic report performed after surgical operation. 4)Disease phase on the basis of III-IV endometriosis classification proposed by American Fertility Society. The disease phase definition performed during previous surgical operation. 5)Entering treatment with GnRH agonist (leuproreline) to reduce pain symptoms 6)VAS score =>3 before treatment 7)HAM-A and HAM-D =>7 before treatment. All participants will sign a written informed consent; at any time they could decide to discontinue the treatment.Women on antidepressants, psychostimulants, sedative-hypnotics or narcotic analgesic require to remain off of them for at least two weeks before entry into the study and for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnancy 2)Feeding 3)Use of oral contraceptives 4)Alcohol or illicit drug use (according to DSM-IV criteria) 5)HIV/HCV positivity 6) experimental drugs and excipients hypersensitivity reactions 7)Withdraw of written consent during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the superiority of Paroxetine (selective inhibitor of serotonine reuptake) added to GnRH agonist versus the monotherapy of GnRH agonist in the treatment of endometriosis-related pelvic pain.;Secondary Objective: To assess the improvement of depressive and anxious symptoms (often side effects of GnRH agonist therapy) using paroxetine added to GnRH agonist (leuprorelin).;Primary end point(s): To assess the superiority of Paroxetine (selective inhibitor of serotonine reuptake) added to GnRH agonist versus the monotherapy of GnRH agonist in the treatment of endometriosis-related pelvic pain. A significant statistical reduction of painful symptoms ( a mean decrease of 3-4 points at the Visual Analogue Scale) was observed in women treated with GnRH analogs, (Petta C.A. et al.,2005; Sesti F. et al.,2007); the aim of this study is further reduction of 1-1,5 points at VAS by using paroxetine add-on therapy. | — |
Countries
Italy
Outcome results
None listed