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Pregabalin for Chronic Pelvic Pain in Women
Sponsor: Beijing Tiantan Hospital
Summary
This multicenter, randomized, prospective, open-label, controlled trial will evaluate the efficacy and safety of oral pregabalin as an adjunct to standard conservative treatment in women with chronic pelvic pain (CPP). Approximately 308 women aged 18 to 65 years with moderate to severe CPP lasting more than 6 months will be enrolled and randomly assigned in a 1:1 ratio to either standard conservative treatment alone or standard conservative treatment plus oral pregabalin. Standard conservative treatment will follow a biopsychosocial management approach and may include patient education, body awareness therapy, cognitive interventions, and individualized conservative care. Participants assigned to the pregabalin group will receive oral pregabalin beginning at 150 mg/day in two divided doses. The dose may be gradually increased according to pain relief and tolerability, up to a maximum of 600 mg/day, and maintained for 12 weeks. The primary outcome is the change in mean pain intensity from baseline to Week 12, measured using a visual analogue scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Secondary outcomes include pain intensity at Weeks 2, 4, 8, and 12; pregabalin dosage; overall treatment satisfaction; health-related quality of life assessed using the Short Form-12 questionnaire; gynecologic pain assessed using the McCormack scale; and adverse events throughout the study. The total follow-up period is 12 weeks, with assessments conducted at Weeks 2, 4, 8, and 12. Because of the open-label design, participants and treating physicians will know the treatment assignment. Outcome assessors and statisticians will be blinded to treatment allocation. The study will determine whether adding pregabalin to standard conservative treatment improves pain and related patient-reported outcomes while maintaining an acceptable safety profile in women with CPP.
Official title: Pregabalin for Chronic Pelvic Pain in Women: Study Protocol for a Randomized, Prospective, Multicenter, Open Label-controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2026-10-01
Completion Date
2027-12-01
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Pregabalin
Oral pregabalin administered as adjunctive therapy to standard conservative treatment for chronic pelvic pain. Treatment will begin at 150 mg/day in two divided doses. The dose may be increased by 150 mg/day at intervals of 3 to 7 days according to pain control and tolerability, up to a maximum of 600 mg/day. Once an effective and tolerated dose is established, it will be maintained through the 12-week treatment period. Pregabalin will then be gradually tapered after Week 12 based on the maintenance dose, clinical condition, and withdrawal symptoms.
Behavioral Treatment
Standard conservative treatment consisting of a biopsychosocial management approach, including patient education, body awareness therapy, cognitive interventions, individualized clinical advice, and other appropriate conservative care.