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

NCT00983736 | Terminated Phase 3

• 1 other identifier: BVF-324-302
• Study Type: interventional
• Target: 1,050
• Locations: 5 countries
• Sites: 48

Brief 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"). 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

Outcome Measures

Primary Outcomes (1)

• Increase in IELT (Intravaginal ejaculatory time)

  Per attempt at sexual intercourse

Secondary Outcomes (1)

• Efficacy of using Tramadol for Premature Ejaculation

  At each attempt

Study Arms (2)

Active

EXPERIMENTAL

Drug: Tramadol Hydrochloride

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tramadol Hydrochloride DRUG

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.

Active

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (48)

MHAT, Urology Clinic, 8A G. Kochev Str.

Pleven, Bulgaria

Location

MHAT Plovdiv

Plovdiv, Bulgaria

Location

MHAT Sveti Georgl Plovdiv, Urology Clinic, 66 Peshtersko Shosse Str.

Plovdiv, Bulgaria

Location

MHAT Ruse, Urology Depart., 2 Nezavisimost Str.

Rousse, Bulgaria

Location

CCB SAI Ministry of Interior, 79A, Skobelev Blvd.

Sofia, Bulgaria

Location

MHAT Aleksandrovska, Urology Clinic, 1st, Georgi Sofiski Str.

Sofia, Bulgaria

Location

MHAT Doverie, Urology Depart, 2 Ovcha Kupel, Quadrant 18

Sofia, Bulgaria

Location

SHAT Endocrinology "Academic Ivan Penchev"

Sofia, Bulgaria

Location

MHAT "Sveta Anna" Varna Urology Clinic

Varna, 9002, Bulgaria

Location

MHAT DR Stefan Cherkezov

Veliko Tarnovo, Bulgaria

Location

Urazova Nemocnice v Brne

Brno, Czechia

Location

Andrologicka Ambulance

Hradec Králové, Czechia

Location

Psychiatricke Oddeienf and Sexuologicka Ambulance

Pardubice, Czechia

Location

Soukroma Sexuologicka a Psychiatricka Ambulance

Pilsen, Czechia

Location

Androgeos S. R. O.

Prague, Czechia

Location

Fakultni Thomayerova Nemocnice

Prague, Czechia

Location

TH Klinika S.R.O.

Prague, Czechia

Location

Urologicka Klinika S.R.O.

Prague, Czechia

Location

Medicentrum Olomouc, S.T.O.

Řepčín, Czechia

Location

Allami Egeszegugyi Kozpont (State Health Center)

Budapest, Hungary

Location

Donatella 99BT Private Healthcare Center

Budapest, Hungary

Location

Erector Clinic Uro-Szexologiai Centrum

Budapest, Hungary

Location

Semmelwiis Egyetem Urolgiai Klinika

Budapest, Hungary

Location

Mediroyal Prevention Center

Györe, Hungary

Location

Soproni Erzesebet Oktato Korhaz

Györe, Hungary

Location

Szegeci Tudomanyegyetem Altalanos Orvostudomanyl Kar Urologial Kinika

Kálvária, Hungary

Location

Sandor Egeszegogyl Kozpont

Vinár, Hungary

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

Location

Klinika Urologii Uniwersytet Medyczny

Gdansk, 80-402, Poland

Location

Nzoz Vip-Med

Gdynia, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Katowice, Poland

Location

Prywatna Praktyka Seksuologiczna

Lodz, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Poznan, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Polozniczo-Ginekologiczno-Seksuologiczna

Szczecin, Poland

Location

Nzoz 'Constans-Med'

Todz, Poland

Location

MEDEA Specialistyczny

Warsaw, Poland

Location

Poradnia Seksuologii i Patologll Wiezl Miedzyludzkich

Warsaw, Poland

Location

Szaleckl Lempicki Spolka Partnersaka Lekarzy Urologow

Warsaw, Poland

Location

Gabinet Lekanski Dr. Med. Ryszard Smolinski

Wroclaw, Poland

Location

Spitalul Clinic de Urgenta "Sf. Loan", Urologie

Bucharest, Romania

Location

Spitalul Clinic de Urgenta Militar Central "Dr. Carol Davila"

Bucharest, Romania

Location

Spitalul Clinicl Prof. Theodor Burghele, Sectia Urologie II

Bucharest, Romania

Location

Uro-andro-Med SRL

Bucharest, Romania

Location

Provita 2000 SRL

Constanța, Romania

Location

Spitalul Clinic Judetean de Urgenta Craiova, Sectia Urologie

Craiova, Romania

Location

Spitalul Clinic Constantin Bucuras

Judetul Timis, Romania

Location

Spitalul Clinic Judetean de Urgenta Oradea, Urologie

Oradea, Romania

Location

Centrul Medical 'SF. Pantelimon', Cabinetul de Urologie

Pantelimon, Romania

Location

Related Publications (1)

• 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.

  PMID: 21889833 DERIVED

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Peter Nyiradi, MD

  Mediroyal Prevention Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 27, 2012

Record last verified: 2010-11

Locations

BU (10); CZ (9); HU (8); PL (12); RO (9)