DutasteridePhase 2/3NCT04756206
Role of Dutasteride in Treatment of Chronic Prostatitis
A Phase 2/3 study testing Dutasteride 0.5 mg in people with Dutasteride and Category IIIB Chronic Prostatitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Dutasteride, Category IIIB Chronic Prostatitis
- What is being tested?
- Dutasteride 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Sep 2020
- Phase
- Phase 2/3
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months
Who cannot join
- Patients with bacterial prostatitis
- documented site of infection along the urinary tract,
- urinary bladder tumors
- prostate cancer
- previous history of pelvic radiation or chemotherapy were excluded from our study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)
this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3.
Read the detailed description
Nonbacterial prostatitis refers to a condition that affects patients who present with symptoms of prostatitis without a positive culture for urine or expressed prostate secretions (EPS). With time our understanding of prostatitis was evolved to include a different clinical phenotype with a variety of voiding presentation and symptomatology rather than just inflammation and infection. The two main clinical presentations of prostatitis include pelvic pain and LUTS.
The National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) proposed the first classification of prostatitis into 4 categories in 1995 that was later published in 1998. Bacterial prostatitis represented category I and III while nonbacterial prostatitis including chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was categorized as category III that was further subdivided into class IIIa (inflammatory CPPS) and b (non-inflammatory CPPS). Category IV encompasses asymptomatic inflammatory prostatitis.
Shoskes et al, mentioned that inflammation and the upregulation of cytokine expression and release in the prostate secondary to an inflammatory process led to the presenting symptoms in such a condition. The recently introduced UPOINT phenotype categorization of CP/CPPS (Urinary, Psychosocial, Organ-specific, Infection, Neurological/Systemic, Tenderness of the skeletal muscles). This categorization shows up to 60% of men have at least prostate organ associated symptoms.
The prostate lies under the hormonal control of dihydrotestosterone (DHT); thus 5 alpha-reductase inhibitors (5ARIs) might be beneficial in the treatment of prostatitis. Dutasteride is a 5α-reductase inhibitor, and hence is a type of anti-androgen. It works by decreasing the production of (DHT) in certain parts of the body like the prostate gland. It inhibits all three forms of 5α-reductase and can decrease DHT levels in the blood by up to 98%.
5ARIs have been previously evaluated on a narrow scale in the management of prostatitis with promising results of safety and efficacy.
- Conditions
- Dutasteride, Category IIIB Chronic Prostatitis
- Being tested
- Dutasteride 0.5 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutasteride 0.5 mgDrug
patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
PlaceboDrug
patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Active comparator | Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Receives: Drug: Dutasteride 0.5 mg |
| Placebo | Placebo comparator | same form and color of Dutasteride tablet was given at the same regimen to act as a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH chronic prostatitis symptom index in study population
scoring system aims to evaluate chronic prostatitis and severity of symptoms
Measured: assessment was made before treatment
NIH chronic prostatitis symptom index in study population
scoring system aims to evaluate chronic prostatitis and severity of symptoms
Measured: assessment was made at 3 months after intervention
Secondary outcomes (3)
change in libido in study population
according to sexual desire inventory -2
Measured: 3 months after medication
Gastritis in study population
side effect of medication (if present or not)
Measured: 3 months after medication
Dizziness in study population
side effect of medication (if present or not)
Measured: 3 months after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Sep 2020
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 DutasterideStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756206
- Sponsor's protocol ID
- R21/2020
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Higazy A, Shorbagy AA, Shabayek M, Radwan A, Halim GN, Osman D, Osman T. Short course of dutasteride in treatment of a refractory category IIIB chronic prostatitis (A placebo-controlled study). Prostate Int. 2022 Dec;10(4):213-217. doi: 10.1016/j.prnil.2022.06.002. Epub 2022 Jun 20.
PubMed 36570649
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)
- ClinicalTrials.gov ID
- NCT04756206
- Acronym / sponsor ID
- R21/2020
- Conditions
- Dutasteride, Category IIIB Chronic Prostatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Feb 2021 (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 placebo controlled study aims to evaluate the efficacy of Dutasteride in the management of Chronic prostatitis type 3.
Detailed description
Nonbacterial prostatitis refers to a condition that affects patients who present with symptoms of prostatitis without a positive culture for urine or expressed prostate secretions (EPS). With time our understanding of prostatitis was evolved to include a different clinical phenotype with a variety of voiding presentation and symptomatology rather than just inflammation and infection. The two main clinical presentations of prostatitis include pelvic pain and LUTS.
The National Institutes of Health and the National Institute of Diabetes and Digestive and Kidney Diseases (NIH-NIDDK) proposed the first classification of prostatitis into 4 categories in 1995 that was later published in 1998. Bacterial prostatitis represented category I and III while nonbacterial prostatitis including chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was categorized as category III that was further subdivided into class IIIa (inflammatory CPPS) and b (non-inflammatory CPPS). Category IV encompasses asymptomatic inflammatory prostatitis.
Shoskes et al, mentioned that inflammation and the upregulation of cytokine expression and release in the prostate secondary to an inflammatory process led to the presenting symptoms in such a condition. The recently introduced UPOINT phenotype categorization of CP/CPPS (Urinary, Psychosocial, Organ-specific, Infection, Neurological/Systemic, Tenderness of the skeletal muscles). This categorization shows up to 60% of men have at least prostate organ associated symptoms.
The prostate lies under the hormonal control of dihydrotestosterone (DHT); thus 5 alpha-reductase inhibitors (5ARIs) might be beneficial in the treatment of prostatitis. Dutasteride is a 5α-reductase inhibitor, and hence is a type of anti-androgen. It works by decreasing the production of (DHT) in certain parts of the body like the prostate gland. It inhibits all three forms of 5α-reductase and can decrease DHT levels in the blood by up to 98%.
5ARIs have been previously evaluated on a narrow scale in the management of prostatitis with promising results of safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | Active comparator | Drug: Dutasteride 0.5 mgDutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. |
| Placebo | Placebo comparator | Drug: Placebosame form and color of Dutasteride tablet was given at the same regimen to act as a placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months
Key exclusion criteria (5 listed)
- Patients with bacterial prostatitis
- documented site of infection along the urinary tract,
- urinary bladder tumors
- prostate cancer
- previous history of pelvic radiation or chemotherapy were excluded from our study.
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 |
|---|---|---|
| Dutasteride 0.5 mgpatients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention. | Drug | Dutasteride |
| Placebopatients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention. | Drug | Placebo |
Primary outcome
NIH chronic prostatitis symptom index in study population
Time frame: assessment was made before treatment
scoring system aims to evaluate chronic prostatitis and severity of symptoms
NIH chronic prostatitis symptom index in study population
Time frame: assessment was made at 3 months after intervention
scoring system aims to evaluate chronic prostatitis and severity of symptoms
3 secondary outcomes
change in libido in study population
Time frame: 3 months after medication
Gastritis in study population
Time frame: 3 months after medication
Dizziness in study population
Time frame: 3 months after medication
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 16 Feb 2021.
- Derived from this study: PubMed 36570649Higazy A, Shorbagy AA, Shabayek M, Radwan A, Halim GN, Osman D, Osman T. Short course of dutasteride in treatment of a refractory category IIIB chronic prostatitis (A placebo-controlled study). Prostate Int. 2022 Dec;10(4):213-217. doi: 10.1016/j.prnil.2022.06.002. Epub 2022 Jun 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dutasteride 0.5 mg in people with Dutasteride and Category IIIB Chronic Prostatitis, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 5 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
NIH chronic prostatitis symptom index in study population (time frame: assessment was made before treatment). The study lists 2 primary outcomes in all. 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 NCT04756206, 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 16 Feb 2021.