Pregabalin for Chronic Pelvic Pain in Women

NCT07818577 | Not Yet Recruiting DMC

• 1 other identifier: KY2026-130-02-01
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Pelvic Pain Syndrome; Chronic Pelvic Pain

Keywords

chronic pain; pregabalin; chronic pelvic pain

Outcome Measures

Primary Outcomes (1)

• Change in Mean Pain Intensity From Baseline to Week 12

  Change in mean chronic pelvic pain intensity measured using a visual analogue scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).

  Baseline to Week 12

Secondary Outcomes (6)

• Mean Pain Intensity at Follow-up Visits

  Weeks 2, 4, 8, and 12

• Pregabalin Dose

  Weeks 2, 4, 8, and 12

• Overall Treatment Satisfaction

  Weeks 2, 4, 8, and 12

• Health-related Quality of Life

  Weeks 2, 4, 8, and 12

• Gynecologic Pain-related Symptoms

  Weeks 2, 4, 8, and 12

Study Arms (2)

Standard treatment group

ACTIVE COMPARATOR

Participants will receive standard conservative treatment for chronic pelvic pain based on a biopsychosocial management approach. Treatment may include patient education, body awareness therapy, cognitive interventions, individualized advice, and other conservative measures provided according to clinical assessment and applicable guidelines. No pregabalin will be administered as part of the study intervention.

Drug: Pregabalin; Behavioral: Behavioral Treatment

Combined treatment group

EXPERIMENTAL

Participants will receive the same standard conservative treatment as the Standard Conservative Treatment arm, together with oral pregabalin. Pregabalin will be initiated at 150 mg/day in two divided doses and may be increased gradually according to pain control and tolerability, up to a protocol-defined maximum of 600 mg/day. The individualized maintenance dose will be continued during the 12-week treatment period. After the treatment period, pregabalin will be tapered gradually according to the participant's maintenance dose, clinical condition, and withdrawal symptoms.

Drug: Pregabalin

Interventions

Pregabalin DRUG

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.

Combined treatment group; Standard treatment group

Behavioral Treatment BEHAVIORAL

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.

Standard treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women of all self-identified genders are eligible to participate, provided they meet all other study eligibility criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-65 years.
• Diagnosis of chronic pelvic pain based on the 2022 revisions to the European Association of Urology criteria.
• Use of, or willingness to use, effective contraception to avoid pregnancy during the study period.
• Moderate to severe chronic pelvic pain lasting more than 6 months. Moderate pain is defined as a VAS score of 4-6, and severe pain as a VAS score of 7 or higher.
• Sufficient cognitive and language skills to comply with all study requirements.

You may not qualify if:

• Dysmenorrhea as the sole pain complaint.
• History of malignancy.
• Current or previous use of pregabalin.
• Planned surgery within the next 6 months.
• Contraindication to pregabalin or a previous adverse reaction to pregabalin.
• Current use of gonadotropin-releasing hormone agonists with inability or unwillingness to discontinue treatment.
• Pregnancy, breastfeeding, or intention to become pregnant within the next 6 months.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Pregabalin; Behavior Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Fang Luo, Doctor

CONTACT

13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09