Chronic Pelvic PainNCT07818577
Pregabalin for Chronic Pelvic Pain in Women
A study testing Pregabalin and Behavioral Treatment in people with Chronic Pelvic Pain and Chronic Pelvic Pain Syndrome, run by Beijing Tiantan Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
- What is being tested?
- Pregabalin and Behavioral Treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Sufficient cognitive and language skills to comply with all study requirements.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pregabalin for Chronic Pelvic Pain in Women: Study Protocol for a Randomized, Prospective, Multicenter, Open Label-controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
- Being tested
- Pregabalin, Behavioral Treatment
- Keywords
- chronic pain, pregabalin, chronic pelvic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
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 TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 12
Secondary outcomes (6)
Mean Pain Intensity at Follow-up Visits
Mean pain intensity measured using the VAS at each scheduled follow-up assessment.
Measured: Weeks 2, 4, 8, and 12
Pregabalin Dose
Daily pregabalin dose administered to participants in the pregabalin group, recorded at each follow-up assessment.
Measured: Weeks 2, 4, 8, and 12
Overall Treatment Satisfaction
Participant-reported overall satisfaction with treatment, assessed using a 5-point Likert scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From treatment initiation through Week 12 and post-treatment safety assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818577
- Sponsor's protocol ID
- KY2026-130-02-01
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin for Chronic Pelvic Pain in Women: Study Protocol for a Randomized, Prospective, Multicenter, Open Label-controlled Trial
- ClinicalTrials.gov ID
- NCT07818577
- Acronym / sponsor ID
- KY2026-130-02-01
- Conditions
- Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
- Keywords
- chronic pain, pregabalin, chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment group | Active comparator | Drug: Pregabalin, Behavioral: Behavioral TreatmentParticipants 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. |
| Combined treatment group | Experimental | Drug: PregabalinParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Sufficient cognitive and language skills to comply with all study requirements.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinOral 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. | Drug | Combined treatment group, Standard treatment group |
| Behavioral TreatmentStandard conservative treatment consisting of a biopsychosocial management approach, including patient education, body awareness therapy, cognitive interventions, individualized clinical advice, and other appropriate conservative care. | Behavioural | Standard treatment group |
Primary outcome
Change in Mean Pain Intensity From Baseline to Week 12
Time frame: 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).
6 secondary outcomes
Mean Pain Intensity at Follow-up Visits
Time frame: Weeks 2, 4, 8, and 12
Pregabalin Dose
Time frame: Weeks 2, 4, 8, and 12
Overall Treatment Satisfaction
Time frame: Weeks 2, 4, 8, and 12
Health-related Quality of Life
Time frame: Weeks 2, 4, 8, and 12
Gynecologic Pain-related Symptoms
Time frame: Weeks 2, 4, 8, and 12
Safety outcomes
Time frame: From treatment initiation through Week 12 and post-treatment safety assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin and Behavioral Treatment in people with Chronic Pelvic Pain and Chronic Pelvic Pain Syndrome, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo, Doctor (13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Pain Intensity From Baseline to Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.