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CompletedNCT01108900SUREUpdated Feb 1, 2021

A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil

An observational study in Erectile Dysfunction, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

In the present study, it is planned to observe a population of 100 ED patients treated previously with udenafil and for whom their physician decided to switch them to sildenafil because of poor udenafil tolerance and/or poor efficacy.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Erectile Dysfunction udenafil sildenafil treatment satisfaction
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 100 is below the median of 130 across 115 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Patients, aged >18 years and having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks.

Inclusion criteria

  • Male patients aged ≥ 18 years.
  • Clinical diagnosis of erectile dysfunction supported by a total score of less than or equal to 21 according to Sexual Health Inventory-Male (SHI-M).
  • Patients having a sexual partner throughout the study.
  • Patients having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks.

Exclusion criteria

Exclusion Criteria:

  • The patients for whom sildenafil is contraindicated according to the Local Product Document (LPD). (See appendix D)
  • The patients for whom sexual activity is not indicated.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)

Groups and cohorts

  • Patients with erectile dysfunction (ED)

    100 ED patients in the study that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated

    Drug: sildenafil

Interventions

  • Drugsildenafil

    tables, 25,50,100 mg, on demand, 1 month

06

What researchers measure

Primary outcomes

  1. To observe the treatment satisfaction of ED patients (sum of questions 13-14 IIEF) that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated.

    Time frame: 1 month

Secondary outcomes

  1. To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS.

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01108900
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Apr 22, 2010
Start date
Jul 2010
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Feb 1, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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