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Effect duloxetine versus amitriptyline on clinical outcomes of female with chronic pelvic pain syndrome

Effect duloxetine versus amitriptyline on clinical outcomes of female with chronic pelvic pain syndrome: a double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120215009014N457
Enrollment
48
Registered
2023-01-10
Start date
2023-01-05
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pelvic pain syndrome. Pelvic and perineal pain

Interventions

Intervention 1: Intervention group: Duloxetine tablets 30 mg daily for one week then 60 mg daily for 8 weeks. Intervention 2: Control group: Amitriptyline tablets 25 mg daily for one week then 50 mg d

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age 18 to 50 years Chronic pelvic pain syndrome for more than 6 months

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Suffering from endometriosis, ovarian cyst, adenomyosis, fibroid or genital malignancy Gastrointestinal diseases including irritable bowel syndrome or inflammatory bowel disease History of previous hip surgery Genitourinary infection Cognitive or mental disorders Kidney and liver dysfunction History of alcohol and substance abuse

Design outcomes

Primary

MeasureTime frame
Improvement of clinical symptoms (pain, difficulty in defecation). Timepoint: Before the intervention and one and two months after that. Method of measurement: Using the National Institutes of Health Chronic Syndrome Symptom Index (NIH-CSSI).;The rate of overall response to treatment. Timepoint: Two months after the intervention. Method of measurement: Using the Global Response Assessment (GRA) questionnaire.

Secondary

MeasureTime frame
Occurrence of side effects (nausea, vomiting). Timepoint: one and two months after intervention. Method of measurement: With history taking.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRojan Ghaderzadeh

Hamedan University of Medical Sciences

rojan.ghz7799@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026