An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride

November 25, 2013 updated by: Janssen Research & Development, LLC

A Prospective, Observational Study of Men With Premature Ejaculation Who Are Treated With PRILIGY or Alternate Care

The purpose of the study is to collect information regarding the safety of dapoxetine hydrochloride when used in clinical practice to treat men with premature ejaculation. Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for the treatment of patients with premature ejaculation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a 12-week, observational study to collect and evaluate safety data for dapoxetine hydrochloride and alternate care/non-dapoxetine hydrochloride treatment(s) defined as any treatment (eg, oral, topical, or behavioral) other than dapoxetine hydrochloride, which have been recommended and prescribed for men who have a diagnosis of premature ejaculation. The primary objective of the study is to describe the safety profile of dapoxetine hydrochloride when used in clinical practice. The safety of dapoxetine hydrochloride will be assessed duing the study by monitoring the occurrence of all adverse events experienced by patients including adverse events of special interest (eg, syncope, characterized as loss of consciousness). Safety will also be assessed by monitoring patient use of all concomitant medications/treatments including prescription medications, over the counter medications, vitamins and herbal supplements, and other types of therapies such as electrical stimulation, acupuncture, special diets, and exercise regimens. Approximately 12,000 men with premature ejaculation will be enrolled in the study of which approximately 6,000 patients will be treated with dapoxetine hydrochloride. All patients who present to the practice for an evaluation of premature ejaculation, or who have a diagnosis of premature ejaculation and are currently being treated will be considered for enrollment in the study. All treatment decisions will be made at the discretion of the participating health care provider. The study will consist of 3 periods: a pre-observational (screening/baseline) period (Visit 1), an 12-week observational period (Visits 2, 3, and 4), and a 4-week post-observational period. At Visit 1, the health care provider will make or confirm the diagnosis of premature ejaculation and determine if treatment with dapoxetine hydrochloride or alternate care/non-dapoxetine hydrochloride is appropriate for the patient. There will be no study-specific selection criteria other than the guidance provided by the Summary of Product Characteristics for dapoxetine hydrochloride as it is intended that the participating health care provider will use the Summary of Product Characteristics for dapoxetine hydrochloride as a guide to identify appropriate patients for the study, and the types of patients who should use caution or avoid using dapoxetine hydrochloride. If the healthcare provider determines that the patient is a candidate for the study, he/she will explain the details of the study to the patient. Patients who are interested in participating in the study should be willing and able to be treated with dapoxetine hydrochloride and to continue to participate in the study as long as dapoxetine hydrochloride continues to be administered for the duration of the 12-week observational period, even in those situations where topical and/or behavioral alternate care treatments are added to the dapoxetine hydrochloride treatment regimen. Patients who wish to participate in the study will be asked to sign and date an informed consent to allow the health care provider to collect information required for the study. At Visit 1, a signed informed consent form will be obtained from the patient and information will be collected including demographics (for example, the patient's race and age), medical history including premature ejaculation history, physical examination findings, and orthostatic vital sign (blood pressure and heart rate/pulse) measurements. If the health care provider determines that the patient should be treated with dapoxetine hydrochloride, the health care provider will instruct the patient on the administration of dapoxetine hydrochloride according to the dosage and administration guidelines in the Summary of Product Characteristics for dapoxetine hydrochloride as follows: the recommended starting dose of dapoxetine hydrochloride is 30 mg, taken with or without food with at least one full glass of water approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed. If the effect of dapoxetin hydrochloride at a dose of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. If the health care provider determines that the patient should be treated with alternate care/non-dapoxetine hydrochloride treatment(s), the health care provider will instruct the patient on the administration of those treatments as prescribed or directed. Following Visit 1, all patients will participate in a 12-week observational period where they will return for up to 3 study visits (Visits 2, 3, and 4) according to the health care provider's local practice. At each visit, the health care provider will evaluate if the dose of dapoxetine hydrochloride or alternate care/non-dapoxetine hydrochloride treatment(s) needs to be increased or decreased and information regarding the occurrence of adverse events and the use of concomitant medications/treatment will be collected. Approximately 4 weeks following the end of the 12-week observational period or the patient's last visit in the study, the health care provider will contact the patient by telephone to assess the occurrence of any adverse events experienced by the patient and the use of any concomitant medications or treatments taken since the last study visit. Additional telephone contact with the patient may be performed by the health care provider to obtain additional information to determine the patient's safety or survival status. Regardless of the patient's status at the end of the study (ie, completed, discontinued treatment, withdrew early), patients who receive dapoxetine hydrochloride will be asked to complete a survey to provide feedback to the healthcare provider on the whether or not the dapoxetine hydrochloride Patient Brochure and/or Patient Information Leaflet was useful and informative. Patients may only participate in the study one time. Patients who receive dapoxetine hydrochloride in the study should not be enrolled again to receive alternate care/non-dapoxetine hydrochloride treatment(s) upon study completion or discontinuation of dapoxetine hydrochloride). The recommended starting dose of dapoxetine hydrochloride is 30 mg, taken with or without food with at least 1 full glass of water approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed. Patients will take dapoxetine hydrochloride for 12 weeks during the observational period of the study. Alternate care/non dapoxetine hydrochloride treatment(s) will be administered to patients in accordance with the prescribing information and/or directions for use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10027

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Karpfenberg, Austria
      • Reutte, Austria
      • Vienna, Austria
  • Finland
      • Helsinki, Finland
      • Kouvola, Finland
      • Mikkeli, Finland
      • Oulu, Finland
      • Turku, Finland
  • Germany
      • Ahlen, Germany
      • Ahrensburg, Germany
      • Apolda, Germany
      • Bad Doberan, Germany
      • Bad Schönborn, Germany
      • Bamberg, Germany
      • Bautzen, Germany
      • Berlin, Germany
      • Bonn, Germany
      • Braunschweig, Germany
      • Bremen, Germany
      • Bruchsal, Germany
      • Böblingen, Germany
      • Castrop-Rauxel, Germany
      • Celle, Germany
      • Chemnitz, Germany
      • Dachau, Germany
      • Dessau, Germany
      • Dorsten, Germany
      • Dortmund, Germany
      • Dossenheim, Germany
      • Dresden, Germany
      • Duisburg, Germany
      • Düren, Germany
      • Düsseldorf, Germany
      • Eisenberg, Germany
      • Erfurt, Germany
      • Erlangen, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Garmisch-Partenkirchen, Germany
      • Gotha, Germany
      • Grimma, Germany
      • Grünstadt, Germany
      • Göppingen, Germany
      • Hagenow, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Heilbronn, Germany
      • Hemmoor, Germany
      • Herford, Germany
      • Herten, Germany
      • Herzogenaurach, Germany
      • Hochheim, Germany
      • Höchberg, Germany
      • Jena, Germany
      • Kaiserslautern, Germany
      • Karlsruhe, Germany
      • Kempten, Germany
      • Kiel, Germany
      • Kirchheim, Germany
      • Kleinmachnow, Germany
      • Krefeld, Germany
      • Kronach, Germany
      • Köln, Germany
      • Lampertheim, Germany
      • Landsberg, Germany
      • Leipzig, Germany
      • Leverkusen, Germany
      • Lichtenfels, Germany
      • Lutherstadt Eisleben, Germany
      • Lüdinghausen, Germany
      • Magdeburg, Germany
      • Markkleeberg, Germany
      • Mülheim, Germany
      • München, Germany
      • Münster, Germany
      • Neckargemünd, Germany
      • Neu-Ulm, Germany
      • Neumünster, Germany
      • Neuss, Germany
      • Nordhausen, Germany
      • Nürnberg, Germany
      • Oberursel, Germany
      • Oranienburg, Germany
      • Osnabrück, Germany
      • Ostfildern, Germany
      • Peine, Germany
      • Planegg, Germany
      • Plauen, Germany
      • Radebeul, Germany
      • Rastatt, Germany
      • Remscheid, Germany
      • Reutlingen, Germany
      • Rinteln, Germany
      • Rostock, Germany
      • Rottenberg, Germany
      • Rottweil, Germany
      • Sangerhausen, Germany
      • Schleswig, Germany
      • Schriesheim, Germany
      • Schwerin, Germany
      • Senftenberg, Germany
      • Sindelfingen, Germany
      • Speyer, Germany
      • Stadthagen, Germany
      • Starnberg, Germany
      • Strausberg, Germany
      • Stuttgart, Germany
      • Sömmerda, Germany
      • Taucha, Germany
      • Ulm, Germany
      • Unterschleißheim, Germany
      • Velbert, Germany
      • Villingen-Schwenningen, Germany
      • Wiesbaden, Germany
      • Wiesloch, Germany
      • Wolfenbüttel, Germany
      • Wolfsburg, Germany
      • Wuppertal, Germany
      • Zwickau, Germany
  • Portugal
      • Aveiro, Portugal
      • Braga, Portugal
      • Castelo Viegas N/A, Portugal
      • Estoril, Portugal
      • Lisboa, Portugal
      • Matosinhos N/A, Portugal
      • P-1100 Lisboa N/A, Portugal
      • Portimão, Portugal
      • Póvoa Do Varzim, Portugal
      • Santo Tirso, Portugal
  • Spain
      • Alcorcon, Spain
      • Alginet, Spain
      • Alicante, Spain
      • Almeria, Spain
      • Aravaca, Spain
      • Aviles, Spain
      • Badalona, Spain
      • Barakaldo, Spain
      • Barcelona, Spain
      • Barcelona N/A, Spain
      • Burgos, Spain
      • Cadiz, Spain
      • Calatayud, Spain
      • Calella, Spain
      • Castellon, Spain
      • Ciudad Real, Spain
      • Cordoba, Spain
      • Cullera, Spain
      • Cádiz, Spain
      • El Prat De Llobregat, Spain
      • Gandia, Spain
      • Girona, Spain
      • Granada, Spain
      • Ibiza, Spain
      • Jaen, Spain
      • L'Hospitalet De Llobregat, Spain
      • La Coruña, Spain
      • La Laguna, Spain
      • Las Palmas De Gran Canaria, Spain
      • Leon, Spain
      • Llanera, Spain
      • Lleida, Spain
      • Logroño, Spain
      • Los Boliches, Spain
      • Lugo, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Manacor, Spain
      • Marbella, Spain
      • Mataro, Spain
      • Murcia, Spain
      • Málaga, Spain
      • Ontiyent, Spain
      • Orense, Spain
      • Oviedo, Spain
      • Palamos, Spain
      • Palma De Mallorca, Spain
      • Pamplona, Spain
      • Parla, Spain
      • Pontevedra, Spain
      • Port De Bollenca, Spain
      • Requena, Spain
      • Ribeira, Spain
      • Rota, Spain
      • Sabadell, Spain
      • Salamanca, Spain
      • San Juan De Alicante, Spain
      • San Sebastian, Spain
      • San Sebastian De Los Reyes, Spain
      • Sanlucar De Barrameda, Spain
      • Santa Cruz De Tenerife, Spain
      • Santander, Spain
      • Santiago De Compostela, Spain
      • Sevilla, Spain
      • Silla, Spain
      • Tarragona, Spain
      • Terrassa, Spain
      • Toledo, Spain
      • Utrera, Spain
      • Valencia, Spain
      • Valladolid, Spain
      • Vigo, Spain
      • Vilanova I La Geltru, Spain
      • Villamayor, Spain
      • Xátiva, Spain
      • Zaragoza, Spain
  • Sweden
      • Billdal, Sweden
      • Eskilstuna, Sweden
      • Göteborg, Sweden
      • Karlshamn, Sweden
      • Luleå, Sweden
      • Lund, Sweden
      • Motala, Sweden
      • Stockholm, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men diagnosed with premature ejaculation will be enrolled in the study by participating health care providers in clinical practice settings.

Description

Inclusion Criteria:

  • In accordance with the therapeutic indication stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be candidates for enrollment if they have an intravaginal ejaculatory latency time of less than two minutes
  • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
  • Marked personal distress or interpersonal difficulty as a consequence of premature ejaculation
  • Poor control over ejaculation

Exclusion Criteria:

  • In accordance with the contraindications, special warnings and precautions for use as stated in the Summary of Product Characteristics for dapoxetine hydrochloride, patients will be excluded from treatment if they have hypersensitivity to dapoxetine hydrochloride or to any of the excipients
  • Significant pathological cardiac conditions such as: heart failure (New York Heart Association [NYHA] class II-IV), conduction abnormalities (second or third degree atrioventicular (AV) block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease, or significant valvular disease
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI
  • Concomitant treatment with thioridazine, concomitant treatment with serotonin reuptake inhibitors (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs)] or other medicinal/herbal products with serotonergic effects (for example, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)
  • Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc.
  • Moderate and severe hepatic impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
001
Dapoxetine hydrochloride One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks
Drug: Dapoxetine hydrochloride
One 30 mg tablet up to a maximum of one 60 mg tablet approximately 1 to 3 hours prior to prior to sexual activity once every 24 hours as needed for 12 weeks
002
Alternate care/non-dapoxetine hydrochloride treatment(s) As prescribed or directed
Other: Alternate care/non-dapoxetine hydrochloride treatment(s)
As prescribed or directed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary outcome measure is safety. Safety will be assessed by monitoring the occurrence of adverse events and the use of concomitant medications or therapies during the study.
Time Frame: Safety will be assessed at Visit 1 through 4 during the 12 week observation period and up to approximately 4 weeks after the End-of-Observation/Early Withdrawal Visit.
Safety will be assessed at Visit 1 through 4 during the 12 week observation period and up to approximately 4 weeks after the End-of-Observation/Early Withdrawal Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016477
  • The PAUSE Study (Other Identifier: Janssen Research & Development, LLC)
  • R096769PRE4001 (Other Identifier: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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