Chronic Abacterial ProstatitisPhase 2AZURENCT01391338
A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)
A Phase 2 study testing ASP3652 in people with Chronic Abacterial Prostatitis and Chronic Pelvic Pain Syndrome, run by Astellas Pharma Inc at 49 sites in 6 countries.
Trial summary
In this study several doses of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Abacterial Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- ASP3652
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 49 sitesin 6 countries
- Study dates
- Jun 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is diagnosed with CP/CPPS with symptoms for at least 3 months over the last 6 months
- Has a NIH-CPSI total score of at least 15
- A score of at least 4 on question 4 (pain) in the NIH-CPSI
- Reports pain on palpation of the prostate or the perineum/genital area
- Answers "yes" to at least 1 out of 6 items in question 1 and 2 of the NIH-CPSI
- Is willing to comply with study requirements such as completing the micturition and symptoms diary and attend all study visits
Who cannot join
- Isolated unilateral testicular, penile or scrotal pain as a solitary symptom of pelvic pain
- Urinary Tract Infection (UTI) or prostate infection found at screening using the pre- and post massage test or in the last 3 months prior to screening
- Any prior prostate and or bladder intervention within 3 months prior to screening
- Lower urinary tract malignancy (suspected), such as positive (micro) hematuria in urine sediment or Prostate Specific Antigen (PSA) >4 ng/mL
- Symptomatic urethral stricture or symptomatic bladder or urethral calculi, severe bladder outlet obstruction, overactive bladder with incontinence or Post Void Residual volume, greater than 150 mL
- Clinically significant abnormalities on transabdominal ultrasound of bladder and prostate or neurological disease or defect affecting bladder function
Show all 14Show fewer
- Currently active sexually transmittable disease
- Substance abuse or any use of delta-9-tetrahydrocannabinol (THC) as assessed by a positive urine test for THC at screening
- Major depression, i.e. a Center for Epidemiological Studies Depression Scale score of 27 or more
- Any clinically relevant concomitant disease (past or present) which would, in the opinion of the investigator, put the subject at risk or mask measures of efficacy
- Use of steroids, immunomodulators, anticonvulsants, cytochrome P4502C8 inhibitors, cannabis/THC based medication, opioid analgetics or antiviral/antimicrobial/antifungal agents during the last 4 weeks before screening
- Initiation, discontinuation, or variation in the dose of antidepressants, alpha-blockers, 5-alpha reductase inhibitors, antimuscarinics, benzodiazepines, skeletal muscle relaxants, non-steroidal antiinflammatory drugs, non-opioid analgetics and herbal therapies during the last 4 weeks before screening. Subjects should continue these medications at that same stable dose throughout the study
- Clinically relevant abnormal urine or blood safety laboratory values or active hepatic and/or biliary disease (AST or ALT should not be >3 times the upper limit of normal, total bilirubin should not be >2 times the upper limit of normal)
- Participated in any clinical study or has been treated with any investigational drug or device within 30 days prior to screening, or the period stipulated by local regulations, whichever is longer
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
Germany15 sites
Site: 3212 - Urologische Praxis
Berlin, 10719
Site: 3214 - Charité Campus Benjamin Franklin
Berlin, 12200
Site: 3208 - Private Praxis Urologie Borken
Borken, 46325
Site: 3202 - Urologische Praxis
Buchholz, 21244
Site: 3201 - Universitats klinikum Giessen und Marburg
Giessen, 35392
Site: 3203 - Urologische Praxis
Hamburg, 22587
Site: 3211 - Urologische Gemeinschaftspraxis
Herzogenaurach, 91074
Site: 3205 - Gesundheitszentrum Holzminden
Holzminden, 37603
Site: 3213 - Urologische Praxis
Kempen, 47906
Site: 3206 - Private Praxis
Leipzig, 04179
Site: 3210 - Private Praxis
Marburg, 35039
Site: 3207 - Private Praxis
Markkleeberg, 04416
Site: 3204 - Akademisches Lehrkrankenhaus
Neunkirchen, 66538
Site: 3215 - Urologische Praxis
Reutlingen, 72764
Site: 3209 - Private Praxis
Sangerhausen, 06526
Czechia12 sites
Site: 3105 - Fakultni nemocnice Hradec Kralove
Hradec Králové, 50005
Site: 3106 - Urologicke oddeleniUsti nad Labem
Kolín, 28000
Site: 3109- Hospital Kromeriz
Kroměříž, 76755
Site: 3107 - Urologie
Nový Jičín, 74101
Site: 3103 - Fakultni nemocnice Olomouc
Olomouc, 77200
Site: 3111 - Urology center
Pilsen, 30100
Site: 3112 - Urosante
Prague, 14000
Site: 3102 - Androgeos
Prague, 16000
Site: 3110 - Urologicka ordinace
Sternberk, 78501
Site: 3104 - Uherskohradistska nemocnice a.s.
Uherské Hradiště, 68668
Site: 3101- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 40113
Site: 3113 - Urologicka ambulance
Žatec, 43801
Poland11 sites
Site: 3503 - Urovita Sp.z.o.o. NZOZ Szpital Slaskie Centrum Urologii
Chorzów, 41-500
Site: 3504 - Centrum Medyczne Szpital Sw Rodziny Sp z o.o.
Lodz, 90-302
Site: 3509 - NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Lotum, 87-100
Site: 3510 - Heureka Hanna Szalecka
Piaseczno, 05-500
Site: 3501 - Indywidualna Specjalistyczna Praktyka Lekarska
Poznan, 61-397
Site: 3511 - Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110
Site: 3508 - NZOZ Centrum Medyczna Wola
Warsaw, 01-432
Site: 3507 - Szpital Kliniczny Dzieciatka Jezus Centrum Leczenia Obrazen
Warsaw, 02-005
Site: 3502 - Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, 51-124
Site: 3505 - EMC Instytut Medyczny SA
Wroclaw, 54-144
Site: 3506 - Specjalistyczna Praktyka Lekarska Gabinet Urologiczny
Wroclaw, 54-239
Latvia4 sites
Site: 3302 - Jelgava Outpatient Clinic
Jelgava, LV-3001
Site: 3301 - Litavniece Urologist Private Practice
Liepāja, LV-3401
Site: 3303 - P. Stradins Clinical University Hospital
Riga, LV-1002
Site: 3304 - Nord Kurzeme Regional Hospital
Ventspils, LV-3601
Lithuania4 sites
Site: 3404 - Motina ir vaikas clinic
Kaunas, LT-50154
Site: 3402 - Vilnius Univeristy Hospital "Santariskiu Klinikos" Urology Centre
Vilnius, LT-08661
Site: 3401 - Clinics "Privatus gydytojas"
Vilnius, LT-09108
Site: 3403 - Public Institution Vilnius City University Hospital
Vilnius, LT-10207
Spain3 sites
Site: 3701 - Hospital Moises Broggi de Sant Joa
Barcelona, 8970
Site: 3703 - Fundació Puigvert
Barcelona, CP: 08025
Site: 3702 - Hospital del Henares
Coslada, CP:28822
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of CP/CPPS
In this study several doses of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome.
Read the detailed description
This study will investigate the efficacy of ASP3652 in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS). In comparison with placebo, ASP3652 will be given in different dosages orally for 12 weeks. The aims are to investigate efficacy of ASP3652 in CP/CPPS, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with CP/CPPS in and out-patients setting.
- Being tested
- ASP3652, Placebo
- Keywords
- Prostatitis, Chronic, Pelvic Pain, NIH-CPSI, Pain domain score in NIH-CPSI
- Medical subject headings
- Prostatitis, Bronchiolitis Obliterans Syndrome, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3652Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Lowest dose ASP3652 twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| Low dose ASP3652 twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| Medium dose ASP3652 twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| High dose ASP3652 once daily | Experimental | Not described Receives: Drug: ASP3652 |
| High dose ASP3652 twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks
Measured: Baseline and 12 weeks
Secondary outcomes (15)
Change from baseline in the NIH-CPSI pain domain score at week 12
Measured: Baseline and 12 weeks
Change from baseline in NIH-CPSI total score at 4 and 8 weeks and at 2 weeks follow-up after treatment
Measured: Baseline, 4 weeks, 8 weeks and 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI pain domain at week 4 and 8 and at 2 weeks follow-up after treatment
Measured: Baseline, 4 weeks, 8 weeks 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI urinary symptoms domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI Quality of Life impact domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
Global Response Assessment at week 4, 8 and 12 and at 2 weeks follow-up post treatment
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and at 2 weeks follow-up post treatment
The proportion of Clinical Responders
Composite of two definitions are used: subjects who showed at least 4 points decrease in NIH-CPSI total score at 12 weeks compared to baseline and subjects who showed at least 6 points decrease in NIH-CPSI total score at 12 weeks
Measured: 12 weeks
Genitourinary pain index (GUPI) total score, sub domain and responders, at week 12
Responder defined as 7 points or more decrease from baseline
Measured: 12 weeks
Mean daily CPSI-24hour total score at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
Mean daily pain for the 7 days period prior to attending study visits at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
Short form McGill pain questionnaire: sensory, affective and total score, VAS, present pain intensity at baseline and at 12 weeks
Measured: Baseline and 12 weeks
Voiding: mean number of micturitions per 24 hours and per night, mean number of urgency episodes per 24 hours and mean level of urgency per micturition
Based on daily urinary symptom diary for 3 consecutive days in the weeks prior to the visits at baseline, 4 and 12 weeks treatment
Measured: Baseline, 4 weeks and 12 weeks treatment
International Prostate Symptom Score at screening and at 12 weeks
Measured: Screening and 12 weeks
European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks
Measured: Baseline and 12 weeks
Male sexual health questionnaire at baseline and at 12 weeks
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Abacterial ProstatitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Director Global Medical Science, Study director, Astellas Pharma Europe B.V.Coordination Investigator, Principal investigator, Clinic for Urology, Pediatric Urology and Andrology, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391338
- Sponsor's protocol ID
- 3652-CL-0019
- Other IDs
- 2010-023775-25
- Acronym
- AZURE
- Status last verified
- Mar 2013
- First submitted
- 8 Jul 2011
- Last updated
- 21 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martina R, Houbiers J, Melis J, van Till O. A combined proof of concept and dose finding study with multiple endpoints: A Bayesian adaptive design in chronic prostatitis/chronic pelvic pain syndrome. Biom J. 2019 May;61(3):476-487. doi: 10.1002/bimj.201700210. Epub 2018 Sep 3.
PubMed 30178528
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of CP/CPPS
- ClinicalTrials.gov ID
- NCT01391338
- Acronym / sponsor ID
- AZURE / 3652-CL-0019
- Keywords
- Prostatitis, Chronic, Pelvic Pain, NIH-CPSI, Pain domain score in NIH-CPSI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Jul 2011 (estimated)
- 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.
In this study several doses of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome.
Detailed description
This study will investigate the efficacy of ASP3652 in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS). In comparison with placebo, ASP3652 will be given in different dosages orally for 12 weeks. The aims are to investigate efficacy of ASP3652 in CP/CPPS, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with CP/CPPS in and out-patients setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lowest dose ASP3652 twice daily | Experimental | Drug: ASP3652 |
| Low dose ASP3652 twice daily | Experimental | Drug: ASP3652 |
| Medium dose ASP3652 twice daily | Experimental | Drug: ASP3652 |
| High dose ASP3652 once daily | Experimental | Drug: ASP3652 |
| High dose ASP3652 twice daily | Experimental | Drug: ASP3652 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is diagnosed with CP/CPPS with symptoms for at least 3 months over the last 6 months
- Has a NIH-CPSI total score of at least 15
- A score of at least 4 on question 4 (pain) in the NIH-CPSI
- Reports pain on palpation of the prostate or the perineum/genital area
- Answers "yes" to at least 1 out of 6 items in question 1 and 2 of the NIH-CPSI
Key exclusion criteria (14 listed)
- Isolated unilateral testicular, penile or scrotal pain as a solitary symptom of pelvic pain
- Urinary Tract Infection (UTI) or prostate infection found at screening using the pre- and post massage test or in the last 3 months prior to screening
- Any prior prostate and or bladder intervention within 3 months prior to screening
- Lower urinary tract malignancy (suspected), such as positive (micro) hematuria in urine sediment or Prostate Specific Antigen (PSA) >4 ng/mL
- Symptomatic urethral stricture or symptomatic bladder or urethral calculi, severe bladder outlet obstruction, overactive bladder with incontinence or Post Void Residual volume, greater than 150 mL
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 |
|---|---|---|
| ASP3652Oral | Drug | High dose ASP3652 once daily, High dose ASP3652 twice daily, Low dose ASP3652 twice daily, Lowest dose ASP3652 twice daily, Medium dose ASP3652 twice daily |
| PlaceboOral | Drug | Placebo |
Primary outcome
Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks
Time frame: Baseline and 12 weeks
15 secondary outcomes
Change from baseline in the NIH-CPSI pain domain score at week 12
Time frame: Baseline and 12 weeks
Change from baseline in NIH-CPSI total score at 4 and 8 weeks and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks and 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI pain domain at week 4 and 8 and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI urinary symptoms domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
Change from baseline in NIH-CPSI Quality of Life impact domain at week 4, 8 and 12 and at 2 weeks follow-up after treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and weeks 2 weeks follow-up post treatment
Global Response Assessment at week 4, 8 and 12 and at 2 weeks follow-up post treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks treatment and at 2 weeks follow-up post treatment
The proportion of Clinical Responders
Time frame: 12 weeks
Genitourinary pain index (GUPI) total score, sub domain and responders, at week 12
Time frame: 12 weeks
Mean daily CPSI-24hour total score at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
Mean daily pain for the 7 days period prior to attending study visits at baseline and at 4, 8 and 12 weeks and 2 weeks follow-up post treatment
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks and 2 weeks follow-up post treatment
Short form McGill pain questionnaire: sensory, affective and total score, VAS, present pain intensity at baseline and at 12 weeks
Time frame: Baseline and 12 weeks
Voiding: mean number of micturitions per 24 hours and per night, mean number of urgency episodes per 24 hours and mean level of urgency per micturition
Time frame: Baseline, 4 weeks and 12 weeks treatment
International Prostate Symptom Score at screening and at 12 weeks
Time frame: Screening and 12 weeks
European Quality of Life questionnaire in 5 dimensions (EQ-5D) at baseline and at 12 weeks
Time frame: Baseline and 12 weeks
Male sexual health questionnaire at baseline and at 12 weeks
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- Derived from this study: PubMed 30178528Martina R, Houbiers J, Melis J, van Till O. A combined proof of concept and dose finding study with multiple endpoints: A Bayesian adaptive design in chronic prostatitis/chronic pelvic pain syndrome. Biom J. 2019 May;61(3):476-487. doi: 10.1002/bimj.201700210. Epub 2018 Sep 3.
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. This study is not recruiting at the moment.
Executive Director Global Medical Science study director
Astellas Pharma Europe B.V.
Coordination Investigator principal investigator
Clinic for Urology, Pediatric Urology and Andrology, Germany
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP3652 in people with Chronic Abacterial Prostatitis and Chronic Pelvic Pain Syndrome, run by Astellas Pharma Inc at 49 sites in 6 countries.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Germany, Czechia, Poland, Latvia, Lithuania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), total score at 12 weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01391338, which also lists 1 linked publication.
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 21 Mar 2013.