An interventional study of Pregabalin and Behavioral Treatment in Chronic Pelvic Pain and Chronic Pelvic Pain Syndrome, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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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.
Chronic pelvic pain (CPP) in women is a persistent and multifactorial condition that can substantially affect physical functioning, emotional well-being, sexual health, and quality of life. Pain may arise from multiple overlapping pelvic, urinary, gynecologic, musculoskeletal, and psychosocial factors. Central sensitization, characterized by increased responsiveness of the nervous system to painful and nonpainful stimuli, is considered an important contributor to persistent pain in some patients. Consequently, symptom control often requires an individualized, multimodal approach.
Conservative management, including education, physical and behavioral therapies, and other biopsychosocial interventions, is recommended for women with CPP. However, the response is variable, and some patients continue to experience clinically important pain despite these measures. Common pharmacologic options have limitations: evidence for long-term benefit from nonsteroidal anti-inflammatory drugs is limited, hormonal treatments are applicable only to selected pain conditions, and prolonged opioid therapy is generally discouraged because of safety concerns. Evidence for gabapentinoids in women with CPP is also inconsistent, creating a need to evaluate alternative treatment strategies.
Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels and reduces the release of excitatory neurotransmitters involved in abnormal pain processing. Compared with gabapentin, pregabalin has more predictable absorption and dose-related pharmacokinetics, which may facilitate individualized dose adjustment. Although pregabalin has been studied in other chronic pain conditions and in men with chronic prostatitis/chronic pelvic pain syndrome, high-quality evidence in women with CPP remains limited.
This study is designed to determine whether adding pregabalin to standard conservative care provides clinically meaningful symptom relief for women with moderate to severe CPP. The flexible dose-adjustment approach is intended to reflect clinical practice by balancing analgesic response and tolerability. In addition to pain, the study will examine patient satisfaction, health-related quality of life, gynecologic pain-related symptoms, treatment adherence, and adverse events. The findings may clarify the role of pregabalin as an adjunctive option for women whose symptoms remain insufficiently controlled with conservative treatment alone.
3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.
This study's planned enrollment of 308 is above the median of 60 across 2,387 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Beijing Tiantan Hospital is the lead sponsor of 491 studies on the registry; 295 are open to participants now.
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The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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).
Time frame: Baseline to Week 12
Mean Pain Intensity at Follow-up Visits
Mean pain intensity measured using the VAS at each scheduled follow-up assessment.
Time frame: Weeks 2, 4, 8, and 12
Pregabalin Dose
Daily pregabalin dose administered to participants in the pregabalin group, recorded at each follow-up assessment.
Time frame: Weeks 2, 4, 8, and 12
Overall Treatment Satisfaction
Participant-reported overall satisfaction with treatment, assessed using a 5-point Likert scale.
Time frame: Weeks 2, 4, 8, and 12
Health-related Quality of Life
Physical and mental health-related quality of life assessed using the Short Form-12 (SF-12) questionnaire, scored from 0 to 100, with higher scores indicating better health status.
Time frame: Weeks 2, 4, 8, and 12
Gynecologic Pain-related Symptoms
Gynecologic pain-related symptoms assessed using the McCormack scale, scored from 0 to 3, with higher scores indicating greater gynecologic pain.
Time frame: Weeks 2, 4, 8, and 12
Safety outcomes
Frequency and type of adverse events occurring during the study, including events identified through clinical assessment and participant reporting.
Time frame: From treatment initiation through Week 12 and post-treatment safety assessment
No study locations are listed for this record.
Plan to share: Undecided — Decisions on individual participant data (IPD) sharing have not been finalized at the current trial registration stage. The research team will assess institutional data policies, patient privacy constraints, and future collaborative demands later during the trial. Any formal data-sharing arrangements will be updated promptly on ClinicalTrials.gov once confirmed.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 8 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pregabalin