A Multicenter, Randomized, Parallel Group, Double-Blind,... | NCT00644631

Studies
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate

NCT00644631

Sponsor

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

Status

Completed

Last Update Posted

Feb 1, 2021Actual

Enrollment

300Estimated

Phase

Phase 4

Conditions

Erectile Dysfunction

Interventions

sildenafil
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Apr 2004Actual

First Submitted Date

Mar 25, 2008

First Submission Date that Met QC Criteria

Mar 26, 2008

First Posted Date

Mar 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2021

Last Update Posted Date

Feb 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Active Comparator		Drug: sildenafil
Arm 2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sildenafil	Drug	sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.		Week 12

Secondary Outcomes

Measure	Description	Time Frame
International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients		Week 8 and Week 12
Self-Esteem and Relationship Questionnaire (SEAR) in ED patients		Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The male patient must have had a documented clinical diagnosis of erectile dysfunction (ED) confirmed by a Sexual Health Inventory-Male (SHI-M) score of less than or equal to 21
a stable female partner at least 21 years of age for at least 6 months prior to screening
the couple must have been married or living together at the time of screening.
The female partner must have answered "no intercourse," "sometimes," "a few times" or "almost never" on Question 3 of the Female Partner of ED Subject Questionnaire (FePEDS-Q)

Exclusion Criteria:

The male patient must not have had resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg), or significant cardiovascular disease in the last 3 months, including cardiac failure, myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias.
Female partners must not have had significant dyspareunia or lifelong significant sexual dysfunction based on female partner's medical and sexual history at screening.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Huntsville	Alabama	35801	United States
Pfizer Investigational Site

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological
D052801	Male Urogenital Diseases
D020018	Sexual Dysfunctions, Psychological
D001523	Mental Disorders

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457	Sulfur Compounds
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring