Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction

Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.

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.

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.
Interventional

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.
183

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2L 1K8
        • Pfizer Investigational Site
      • Calgary, Alberta, Canada, T2V 4R6
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5H 4B9
        • Pfizer Investigational Site
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • Pfizer Investigational Site
      • Surrey, British Columbia, Canada, V3V 1N1
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V6Z 2T1
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1K3
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8T 5G1
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Pfizer Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Pfizer Investigational Site
      • Corunna, Ontario, Canada, N0N 1G0
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 3J7
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4V2
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6A 3B5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Pfizer Investigational Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 4A3
        • Pfizer Investigational Site
      • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2X 1N8
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3S 1Z1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 5B1
        • Pfizer Investigational Site
      • Montréal, Quebec, Canada, H2X 1N8
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Pfizer Investigational Site
      • St. Leonard, Quebec, Canada, H1S 3A9
        • Pfizer Investigational Site

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men above age of majority
  • Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion Criteria:

  • Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
  • Subjects currently taking any other commercially available drug or non-drug treatment for ED

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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
Measure Description
Time Frame
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
Time Frame: Week 8
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Time Frame: Week 8, Week 14
Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Week 8, Week 14
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
Time Frame: Week 8
adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Week 8
Patient Reported Erectile Function Assessment (PREFA) Total Score
Time Frame: Week 8, Week 14
PREFA Total Score: 8 = worst, 32 = best.
Week 8, Week 14
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Time Frame: Week 8
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Week 8
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Time Frame: Week 8
adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Week 8
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Time Frame: Week 8
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Week 8
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Time Frame: Week 8
adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Week 8
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Time Frame: Week 8
adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Week 8
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Time Frame: Week 8, Week 14
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Week 8, Week 14
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Time Frame: Week 8, Week 14
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Week 8, Week 14
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Time Frame: Week 8, Week 14
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Week 8, Week 14
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Time Frame: Week 8, Week 14
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Week 8, Week 14
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Time Frame: Week 8, Week 14
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Week 8, Week 14
Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
Time Frame: Week 8
adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Week 8
Erectile Distress Scale (EDS) Total Score
Time Frame: Week 8, Week 14
Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Week 8, Week 14
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
Time Frame: Week 8
adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Week 8
Quality of Erection Questionnaire (QEQ) Total Score
Time Frame: Week 8, Week 14
QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Week 8, Week 14
Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Time Frame: Week 8, Week 14
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Week 8, Week 14
Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Time Frame: Week 8, Week 14
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Week 8, Week 14
Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
Time Frame: Week 8, Week 14
GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Week 8, Week 14
Percentage of Occasions of Successful Intercourse (Event Log)
Time Frame: Baseline to Week 8
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to Week 8
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Time Frame: Baseline to Week 8
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to Week 8
Percentage of Occasions of Successful Intercourse (Event Log)
Time Frame: Week 8 to Week 14
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Week 8 to Week 14
Percentage of Occasions of Ejaculation and/or Orgasm Event Log
Time Frame: Week 8 to Week 14
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Week 8 to Week 14
Change From Baseline to Week 8 in Analog Scales- Firmness
Time Frame: baseline to Week 8
mean change - scale of 0 (worst) to 10 (best).
baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Maintenance
Time Frame: baseline to Week 8
mean change - scale of 0 (worst) to 10 (best).
baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Reliability
Time Frame: baseline to Week 8
mean change - scale of 0 (worst) to 10 (best).
baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
Time Frame: baseline to week 8
mean change - scale of 0 (worst) to 10 (best)
baseline to week 8
Analog Scales- Firmness
Time Frame: Week 8, Week 14
mean - scale of 0 (worst) to 10 (best)
Week 8, Week 14
Analog Scales- Maintenance
Time Frame: Week 8, Week 14
mean - scale of 0 (worst) to 10 (best)
Week 8, Week 14
Analog Scales- Reliability
Time Frame: Week 8, Week 14
mean - scale of 0 (worst) to 10 (best)
Week 8, Week 14
Analog Scales- General Sexual Performance
Time Frame: Week 8, Week 14
mean - scale of 0 (worst) to 10 (best)
Week 8, Week 14
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
Time Frame: Week 8 to Week 14
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Week 8 to Week 14
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Time Frame: Week 8 to Week 14
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Week 8 to Week 14
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Time Frame: Week 8 to Week 14
GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Week 8 to Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Time Frame: Baseline to <= Week 14
Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <= Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Time Frame: Baseline to <Week 8 and Week 8 to <=Week 14
Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14

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.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

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.

General Publications

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.
November 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

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, 2007

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).
March 7, 2006

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.
March 9, 2006

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.
March 10, 2006

Study Record Updates

Last Update Posted (Actual)

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.
February 1, 2021

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.
January 28, 2021

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.
January 1, 2021

More Information

Terms related to this study

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.
  • A1481238

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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