EUCTR2008-008722-73-ITActive, not recruitingNot Applicable
ROLE OF PAROXETINE AS ADD-ON THERAPY TO GNRH AGONIST IN THE TREATMENT OF ENDOMETRIOSIS-RELATED CHRONIC PELVIC PAIN - ND
AZIENDA OSPEDALIERA PISANA0 sitesStarted: March 17, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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
Investigators
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