ROLE OF PAROXETINE AS ADD-ON THERAPY TO GNRH AGONIST IN THE TREATMENT OF ENDOMETRIOSIS-RELATED CHRONIC PELVIC PAIN - ND

• Conditions: Endometriosis-associated pelvic pain; MedDRA version: 9.1Level: LLTClassification code 10014778Term: Endometriosis

• Registration Number: EUCTR2008-008722-73-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified