EjaculationPhase 1NCT01366664
A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin
A Phase 1 study testing Treatment sequence 2 and Treatment sequence 1 in people with Ejaculation, run by Janssen Research & Development, LLC at 6 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ejaculation
- What is being tested?
- Treatment sequence 2 and Treatment sequence 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2011to Apr 2012
- Phase
- Phase 1
- 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
- On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia
- a body mass index between 18 and 35 kg/m², inclusive
- a body weight of not less than 50 kg
- supine (laying down) blood pressure measurements between 90 and 150 mmHg, inclusive
- and, diastolic blood pressure measurements no higher than 95 mmHg.
Who cannot join
- History of current clinically significant illness or any other illness that the investigator considers should exclude the study participant or that could interfere with the interpretation of study results
- symptomatic orthostatic hypotension (a decrease of >=20 mm Hg systolic blood pressure measured after 2 but before 3 minutes after changing from supine (laying down) to standing position)
- taking a medication that is known to cause orthostatic hypotension, other than terazosin
- and, taking more than 2 other antihypertensive medications or taking an antihypertensive medication that is excluded.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Anniston, Alabama
Study site
Costa Mesa, California
Study site
Dallas, Texas
Study site
Knoxville, Tennessee
Study site
Miramar, Florida
Study site
Tempe, Arizona
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking Terazosin
The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.
Read the detailed description
This is a multiple-center, randomized (participants are assigned to study drug by chance), multiple-dose, double-blind (neither physician nor participant knows the treatment assigned), placebo (inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled, 2-period crossover (participants may receive different interventions sequentially during the trial) study to assess the pharmacodynamics, pharmacokinetics, safety, and tolerability of dapoxetine when concomitantly administered in adult male participants who have been on a stable dose of terazosin or doxazosin for at least 6 weeks. Study drugs used will be terazosin (a drug given for the treatment of hypertension and benign prostatic hyperplasia) and dapoxetine (a new drug being studied for the treatment of premature ejaculation). This study consists of a screening phase followed by a double-blind, placebo-controlled treatment phase consisting of 2 treatment periods. Participants will remain on their prescribed dose of terazosin and participants taking doxazosin will be converted to terazosin using the protocol-defined dose conversion (including assessment of control of urinary symptoms and risk for urinary retention). Participants will be administered concomitant (at the same time) dapoxetine or placebo once daily. Blood samples for pharmacodynamic and pharmacokinetic measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation will be approximately 49 days. Participants will remain on their prescribed dose of terazosin (2 to 10 mg taken once daily by mouth) and will be administered daily by mouth concomitant dapoxetine 60 mg or placebo doses during 2 treatment periods (each 7 days in duration conducted in the study center). A period of up to 14 days will separate the treatment periods.
- Conditions
- Ejaculation
- Being tested
- Treatment sequence 2, Treatment sequence 1
- Keywords
- Premature Ejaculation, Selective Serotonin Reuptake Inhibitor, Dapoxetine, PRILIGY, Terazosin, Pharmacodynamic, Pharmacokinetic
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment sequence 2Drug
Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days)
Treatment sequence 1Drug
Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days)
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Treatment sequence 1 Treatment Period 1 (stable dose of terazosin [2 to 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2 to 10 mg] + placebo administered orally once daily for 5 days) Receives: Drug: Treatment sequence 1 |
| 002 | Experimental | Treatment sequence 2 Treatment Period 1 (stable dose of terazosin [2 to 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2 to 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) Receives: Drug: Treatment sequence 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between standing and supine blood pressure measurements
Measured: Days 1-2
Difference between standing and supine blood pressure measurements
Measured: Days 5-6
Secondary outcomes (6)
Plasma concentrations of dapoxetine
Measured: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4
Plasma concentrations of dapoxetine metabolite desmethyldapoxetine
Measured: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4
Number and type of adverse events
Measured: Up to a Maximum of 26 Days
Clinical laboratory test values
Measured: Up to a Maximum of 26 Days
Physical examination findings
Measured: Up to a Maximum of 26 Days
Vital sign measurements
Measured: Up to a Maximum of 26 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EjaculationStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366664
- Sponsor's protocol ID
- CR018607
- Other IDs
- R096769PRE1005
- Status last verified
- Oct 2014
- First submitted
- 2 Jun 2011
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking Terazosin
- ClinicalTrials.gov ID
- NCT01366664
- Acronym / sponsor ID
- CR018607
- Conditions
- Ejaculation
- Keywords
- Premature Ejaculation, Selective Serotonin Reuptake Inhibitor, Dapoxetine, PRILIGY, Terazosin, Pharmacodynamic, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jun 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.
The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.
Detailed description
This is a multiple-center, randomized (participants are assigned to study drug by chance), multiple-dose, double-blind (neither physician nor participant knows the treatment assigned), placebo (inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled, 2-period crossover (participants may receive different interventions sequentially during the trial) study to assess the pharmacodynamics, pharmacokinetics, safety, and tolerability of dapoxetine when concomitantly administered in adult male participants who have been on a stable dose of terazosin or doxazosin for at least 6 weeks. Study drugs used will be terazosin (a drug given for the treatment of hypertension and benign prostatic hyperplasia) and dapoxetine (a new drug being studied for the treatment of premature ejaculation). This study consists of a screening phase followed by a double-blind, placebo-controlled treatment phase consisting of 2 treatment periods. Participants will remain on their prescribed dose of terazosin and participants taking doxazosin will be converted to terazosin using the protocol-defined dose conversion (including assessment of control of urinary symptoms and risk for urinary retention). Participants will be administered concomitant (at the same time) dapoxetine or placebo once daily. Blood samples for pharmacodynamic and pharmacokinetic measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation will be approximately 49 days. Participants will remain on their prescribed dose of terazosin (2 to 10 mg taken once daily by mouth) and will be administered daily by mouth concomitant dapoxetine 60 mg or placebo doses during 2 treatment periods (each 7 days in duration conducted in the study center). A period of up to 14 days will separate the treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Treatment sequence 1Treatment sequence 1 Treatment Period 1 (stable dose of terazosin [2 to 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2 to 10 mg] + placebo administered orally once daily for 5 days) |
| 002 | Experimental | Drug: Treatment sequence 2Treatment sequence 2 Treatment Period 1 (stable dose of terazosin [2 to 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2 to 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia
- a body mass index between 18 and 35 kg/m², inclusive
- a body weight of not less than 50 kg
- supine (laying down) blood pressure measurements between 90 and 150 mmHg, inclusive
- and, diastolic blood pressure measurements no higher than 95 mmHg.
Key exclusion criteria (4 listed)
- History of current clinically significant illness or any other illness that the investigator considers should exclude the study participant or that could interfere with the interpretation of study results
- symptomatic orthostatic hypotension (a decrease of >=20 mm Hg systolic blood pressure measured after 2 but before 3 minutes after changing from supine (laying down) to standing position)
- taking a medication that is known to cause orthostatic hypotension, other than terazosin
- and, taking more than 2 other antihypertensive medications or taking an antihypertensive medication that is excluded.
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 |
|---|---|---|
| Treatment sequence 2Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) | Drug | 002 |
| Treatment sequence 1Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days) | Drug | 001 |
Primary outcome
Difference between standing and supine blood pressure measurements
Time frame: Days 1-2
Difference between standing and supine blood pressure measurements
Time frame: Days 5-6
6 secondary outcomes
Plasma concentrations of dapoxetine
Time frame: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4
Plasma concentrations of dapoxetine metabolite desmethyldapoxetine
Time frame: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4
Number and type of adverse events
Time frame: Up to a Maximum of 26 Days
Clinical laboratory test values
Time frame: Up to a Maximum of 26 Days
Physical examination findings
Time frame: Up to a Maximum of 26 Days
Vital sign measurements
Time frame: Up to a Maximum of 26 Days
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 7 Oct 2014.
- A Randomized, Double-Blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking TerazosinLink provided by the sponsor.
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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.
Janssen Research & Development, LLC C. Clinical Trial study director
Janssen Research & Development, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment sequence 2 and Treatment sequence 1 in people with Ejaculation, run by Janssen Research & Development, LLC at 6 sites in United States.
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 5 inclusion and 4 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Difference between standing and supine blood pressure measurements (time frame: Days 1-2). 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?
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 7 Oct 2014.