Premature EjaculationPhase 3NCT00983736

Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation

A Phase 3 study testing Tramadol Hydrochloride in people with Premature Ejaculation, run by Bausch Health Americas, Inc. at 48 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Premature Ejaculation
What is being tested?: Tramadol Hydrochloride
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: 48 sitesin 5 countries
Study dates: Oct 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
Healthy volunteers accepted
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

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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:
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

48 sites in 5 countries.

Country

City, postcode or hospital

48 sites in 5 countries

Poland12 sites

Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok
Klinika Urologii Uniwersytet Medyczny
Gdansk, 80-402
Nzoz Vip-Med
Gdynia
Indywidualna Specjalistyczna Praktyka Lekarska
Katowice
Prywatna Praktyka Seksuologiczna
Lodz
Indywidualna Specjalistyczna Praktyka Lekarska
Poznan
Indywidualna Specjalistyczna Praktyka Lekarska Polozniczo-Ginekologiczno-Seksuologiczna
Szczecin
Nzoz 'Constans-Med'
Todz
MEDEA Specialistyczny
Warsaw
Poradnia Seksuologii i Patologll Wiezl Miedzyludzkich
Warsaw
Szaleckl Lempicki Spolka Partnersaka Lekarzy Urologow
Warsaw
Gabinet Lekanski Dr. Med. Ryszard Smolinski
Wroclaw

Other trials in Poland

Bulgaria10 sites

MHAT, Urology Clinic, 8A G. Kochev Str.
Pleven
MHAT Plovdiv
Plovdiv
MHAT Sveti Georgl Plovdiv, Urology Clinic, 66 Peshtersko Shosse Str.
Plovdiv
MHAT Ruse, Urology Depart., 2 Nezavisimost Str.
Rousse
CCB SAI Ministry of Interior, 79A, Skobelev Blvd.
Sofia
MHAT Aleksandrovska, Urology Clinic, 1st, Georgi Sofiski Str.
Sofia
MHAT Doverie, Urology Depart, 2 Ovcha Kupel, Quadrant 18
Sofia
SHAT Endocrinology "Academic Ivan Penchev"
Sofia
MHAT "Sveta Anna" Varna Urology Clinic
Varna, 9002
MHAT DR Stefan Cherkezov
Veliko Tarnovo

Other trials in Bulgaria

Czechia9 sites

Urazova Nemocnice v Brne
Brno
Andrologicka Ambulance
Hradec Králové
Psychiatricke Oddeienf and Sexuologicka Ambulance
Pardubice
Soukroma Sexuologicka a Psychiatricka Ambulance
Pilsen
Androgeos S. R. O.
Prague
Fakultni Thomayerova Nemocnice
Prague
TH Klinika S.R.O.
Prague
Urologicka Klinika S.R.O.
Prague
Medicentrum Olomouc, S.T.O.
Řepčín

Other trials in Czechia

Romania9 sites

Spitalul Clinic de Urgenta "Sf. Loan", Urologie
Bucharest
Spitalul Clinic de Urgenta Militar Central "Dr. Carol Davila"
Bucharest
Spitalul Clinicl Prof. Theodor Burghele, Sectia Urologie II
Bucharest
Uro-andro-Med SRL
Bucharest
Provita 2000 SRL
Constanța
Spitalul Clinic Judetean de Urgenta Craiova, Sectia Urologie
Craiova
Spitalul Clinic Constantin Bucuras
Judetul Timis
Spitalul Clinic Judetean de Urgenta Oradea, Urologie
Oradea
Centrul Medical 'SF. Pantelimon', Cabinetul de Urologie
Pantelimon

Other trials in Romania

Hungary8 sites

Allami Egeszegugyi Kozpont (State Health Center)
Budapest
Donatella 99BT Private Healthcare Center
Budapest
Erector Clinic Uro-Szexologiai Centrum
Budapest
Semmelwiis Egyetem Urolgiai Klinika
Budapest
Mediroyal Prevention Center
Györe
Soproni Erzesebet Oktato Korhaz
Györe
Szegeci Tudomanyegyetem Altalanos Orvostudomanyl Kar Urologial Kinika
Kálvária
Sandor Egeszegogyl Kozpont
Vinár

Other trials in Hungary

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 patient and the patient's 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 HydrochlorideDrug
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.
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 groups in NCT00983736
Study group	Role	What they receive
Active	Experimental	Not described Receives: Drug: Tramadol Hydrochloride
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.

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.

Oct 2009Sep 2010

First posted24 Sep 2009 (estimated)
Study startOct 2009
Primary completionSep 2010
Study completionSep 2010

Why it stopped: This study was terminated because of recruitment difficulties.

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00983736
Sponsor's protocol ID: BVF-324-302
Status last verified: Nov 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
Active, not recruitingObservational study
Impact of Depression Severity on Sexual Dysfunction
Depression, Erectile Dysfunction

All Premature Ejaculation trials

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: NCT00983736
Acronym / sponsor ID: BVF-324-302
Conditions: Premature Ejaculation
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated because of recruitment difficulties.
Enrolment: 1,050 participants (estimated)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 24 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.

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 comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: 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 (49 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

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 Hydrochloride89 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
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	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 (reason given: This study was terminated because of recruitment difficulties.). 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.

Related trials for Premature Ejaculation

Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
Active, not recruitingObservational study
Impact of Depression Severity on Sexual Dysfunction
Depression, Erectile Dysfunction

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.

Peter Nyiradi, MD principal investigator

Mediroyal Prevention Center

48 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tramadol Hydrochloride in people with Premature Ejaculation, run by Bausch Health Americas, Inc. at 48 sites in 5 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 49 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 48 sites in Poland, Bulgaria, Czechia, Romania, Hungary. 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 (reason given: This study was terminated because of recruitment difficulties.). 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 NCT00983736, 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.