Premature EjaculationPhase 3NCT00983151
Study to Evaluate Efficacy and Safety in Males Subjects With Premature Ejaculation
A Phase 3 study of Premature Ejaculation, run by Bausch Health Americas, Inc. at 38 sites in 7 countries.
Trial summary
The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Premature Ejaculation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,050 participants
- Where
- 38 sitesin 7 countries
- Study dates
- Aug 2009to Sep 2010
- Phase
- Phase 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for study participation if all of the following criteria are met:
- Male subject and female partner to provide written informed consent prior to the performance of any study-specific procedures;
- Candidates will be male subjects aged 18-65 years inclusive, with lifelong premature ejaculation ("lifelong" is defined as starting at the time the subject became sexually active) with an IELT of ≤120 seconds as documented at Visit 2.
- History of premature or rapid ejaculation, determined by following criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV TR):
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after vaginal insertion and before the person wishes it, taking into account factors that affect duration of the excitement phase such as age, novelty of the sexual partner or situation and recent frequency of sexual activity
- The disturbance causes marked distress or interpersonal difficulty
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- The premature ejaculation is not due exclusively to the direct effects of a substance (ab)use
- In a stable, monogamous, heterosexual relationship (> 6 months).
- Willing and able to take study medication as directed at least 2 hours prior to sexual intercourse according to protocol;
- Subject willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews:
- Female sexual partner willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews;
- Able to understand the study procedures, complete the assessments, and communicate with study personnel;
- Subject and partner willing and able to engage in vaginal intercourse at least three times between visits to yield at least three events of vaginal intercourse ;
- Subject and partner willing to use a reliable contraceptive method during the trial period if the partner is not menopausal;
- Partner willing to take pregnancy tests at Visits 1 and 2
- Subject willing to list and document prescription and non-prescription drug use during the study;
- Have a negative urine drug screen at Visits 1 and 2;
- Be in good general health as determined by medical history and physical examination and expected by the Investigator to complete the study as designed.
Who cannot join
- Subjects are not eligible for study participation if any of the following criteria are met:
- Premature ejaculation attributable to situational or relationship issues;
- Evidence or a history of other significant psychiatric disorder as defined as requiring therapy or medication;
- Subjects who in the Investigator's opinion are at significant risk of suicide.
- Physical illnesses i.History of seizures ii.Prostatitis (current) iii.Urethritis or other urinary tract infections (current) iv.Prior genital surgery (other than vasectomy or circumcision) v.Uncontrolled Diabetes mellitus vi.Respiratory Depression vii.Thyroid disease viii.Chronic moderate to severe neurological disease ix.Significant heart disease treated with cardiac drugs x.Chronic liver disease xi.Chronic kidney disease xii.History of cardiovascular disease (myocardial infarction, congestive heart failure, angina, coronary artery disease or stroke) xiii.Known to be a carrier of the hepatitis B surface antigen, hepatitis C virus antibody, and/or immunodeficiency virus-1 and/ or 2 antibodies xiv.Other disorder that may cause sexual dysfunction
- Other sexual dysfunction:
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- i.Erectile dysfunction. As defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV TR), the diagnostic criteria for male erectile disorder (302,72) erectile dysfunction includes:
- A.Persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate erection.
- B.The disturbance causes marked distress or interpersonal difficulty. ii.Primary reduced sexual desire unrelated to premature ejaculation
- Sexual intercourse usually less than once per week;
- Partner sexual dysfunction (for example dyspareunia or other conditions considered relevant);
- Current use of dapoxetine;
- Current use of any tramadol;
- Sensitivity to phenylketone;
- Any history of abuse of prescription opioids and/or illicit/illegal addictive drugs;
- Has a known hypersensitivity to heparin or history of heparin induced thrombocytopenia;
- Use of medication, within the preceding 30 days, with potential to cause sexual dysfunction: (See Appendix 2 for a list of excluded medications) i.Antidepressants - all types
- ii.Antipsychotic medication
- iii.Antihypertensive medication, unless on a stable dose > 6 months
- iv.Hormonal drugs
- v.Chemotherapy
- vi.Others: cimetidine, clofibrate,quinidine
- Recent psychotropic drug use (within the past 30 days);
- A history of alcohol abuse or dependence within the past 6 months as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV TR);
- Initiation of psychosexual counseling during the screening, baseline or treatment periods;
- Partner positive pregnancy test at Visit 1 or 2;
- History of clinically significant intolerance or a known hypersensitivity to tramadol, such that treatment with it is contraindicated;
- The Investigator anticipates that the subject will be unable to comply with the protocol;
- Received any investigational drug within 30 days prior to Visit 1 or is scheduled to receive an investigational drug during the course of this study;
- Has preplanned surgery or procedures that would interfere with the course of the study.
- A family member (other than the female partner), a staff member, or relative of a staff member..
- Significant laboratory abnormality as determined by the Investigator at Visit 1;
- Significant ECG abnormality at Visit 1 as determined by the Investigator;
- Any other illnesses, conditions or practices that in the Investigator's opinion could interfere with the collection and/or interpretation of study results (couples using the "Withdrawal Method" of birth control will be excluded from the study).
Trial locations and contacts
38 sites in 7 countries.
38 sites in 7 countries
France12 sites
CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques,
Cedex
Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e
Garches
Hopital Henry Gabrielle
Laval
CETPARPjj
Lille
hopital Edouard Herriot
Lyon
Institut de Medecine Sexuelle
Marseille
Hopital Pasteur
Nice
Porle Bouqueyre
Parc Saint-Maur
11 rue Magellan
Paris
Cabinet medical
Paris
76 rue d'Antain, 35700 Rennes
Rennes
Cabinet medical, 10 rue de la Trinite
Toulouse
Sweden7 sites
DW Medical
Eskilstuna
Carlanderska Sjukhuset
Gothenburg
Urohalsan
Jönköping
ProbarE AB
Lund
ProbarE AB
Solna, 141 45
Karolinska University hospital-Huddinge
Stockholm
S3 Clinical Research Centers
Vällingby, 162 68
Belgium6 sites
Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus
Antwerp
Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32
Brussels
UZ Brussel, Laarbeeklaan 101
Brussels
Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10
Edegem
Universitair Ziekenhuis Gent
Ghent
CHU Sart Tilman
Liège
Germany6 sites
Dederweg 2-4
Frankfurt
University Hospital Halle
Halle
Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt
Hanover
Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt
Koin
PUR/R Praxisklinik Urologie 3 Rhein Ruhr
Mühlheim
Spain4 sites
Hospital Universitario Reina Sofla
Córdoba
Hospital Universitario Fundacion Alcordon
Madrid
Clinica El Angel
Málaga
Hospital Universitario Virgen de Rocio
Seville
Netherlands2 sites
Academic Medical Center, Depart. of Urology
Amsterdam
Geert Grooteplein Zuid
Nijmegen
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation
The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.
- Conditions
- Premature Ejaculation
- Being tested
- Tramadol Hydrochloride & Placebo
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Hydrochloride & PlaceboDrug
89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours) Subject will take the study drug for about 27 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Tramadol Hydrochloride & Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Tramadol Hydrochloride & Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in IELT (Intravaginal ejaculatory time)
Measured: Per attempt at sexual intercourse
Secondary outcomes (1)
Efficacy of using Tramadol for Premature Ejaculation.
Measured: At each attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
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 Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert Claes, MD, Principal investigator, Clinique St Jean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983151
- Sponsor's protocol ID
- BVF-324-301
- Status last verified
- Oct 2010
- First submitted
- 22 Sep 2009
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.
PubMed 21889833
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation
- ClinicalTrials.gov ID
- NCT00983151
- Acronym / sponsor ID
- BVF-324-301
- Conditions
- Premature Ejaculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Sep 2009 (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 clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Tramadol Hydrochloride & Placebo |
| Placebo | Placebo comparator | Drug: Tramadol Hydrochloride & Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male subject and female partner to provide written informed consent prior to the performance of any study-specific procedures;
- Candidates will be male subjects aged 18-65 years inclusive, with lifelong premature ejaculation ("lifelong" is defined as starting at the time the subject became sexually active) with an IELT of ≤120 seconds as documented at Visit 2.
- History of premature or rapid ejaculation, determined by following criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV TR):
- In a stable, monogamous, heterosexual relationship (> 6 months).
- Willing and able to take study medication as directed at least 2 hours prior to sexual intercourse according to protocol;
Key exclusion criteria (34 listed)
- Subjects are not eligible for study participation if any of the following criteria are met:
- Premature ejaculation attributable to situational or relationship issues;
- Evidence or a history of other significant psychiatric disorder as defined as requiring therapy or medication;
- Subjects who in the Investigator's opinion are at significant risk of suicide.
- Physical illnesses i.History of seizures ii.Prostatitis (current) iii.Urethritis or other urinary tract infections (current) iv.Prior genital surgery (other than vasectomy or circumcision) v.Uncontrolled Diabetes mellitus vi.Respiratory Depression vii.Thyroid disease viii.Chronic moderate to severe neurological disease ix.Significant heart disease treated with cardiac drugs x.Chronic liver disease xi.Chronic kidney disease xii.History of cardiovascular disease (myocardial infarction, congestive heart failure, angina, coronary artery disease or stroke) xiii.Known to be a carrier of the hepatitis B surface antigen, hepatitis C virus antibody, and/or immunodeficiency virus-1 and/ or 2 antibodies xiv.Other disorder that may cause sexual dysfunction
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 |
|---|---|---|
| Tramadol Hydrochloride & Placebo89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours) Subject will take the study drug for about 27 weeks | Drug | Active, Placebo |
Primary outcome
Increase in IELT (Intravaginal ejaculatory time)
Time frame: Per attempt at sexual intercourse
1 secondary outcome
Efficacy of using Tramadol for Premature Ejaculation.
Time frame: At each attempt
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Derived from this study: PubMed 21889833Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.
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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.
Hubert Claes, MD principal investigator
Clinique St Jean
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Premature Ejaculation, run by Bausch Health Americas, Inc. at 38 sites in 7 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 18 inclusion and 34 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: stopped early, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in France, Sweden, Belgium, Germany, Spain and 2 more countries. 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 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 was stopped early. Results are not available in the source record.
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?
Increase in IELT (Intravaginal ejaculatory time) (time frame: Per attempt at sexual intercourse). 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 NCT00983151, 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 27 Aug 2012.