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Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Sildenafil

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Sildenafil, Vardenafil, Spermatogenesis, Sperm concentration, Sperm count, Morphology, Motility, Reproductive hormonal

Eligibility Criteria

25 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male subjects or men with ED aged 25 - 64
Baseline sperm conc. of > 20 mio / ml- Normal World Health Organization A+B+C sperm mortality > 50%- Normal sperm morphology (WHO, 1992 manual criteria) > 30% and - 1.0 mL ejaculate volume at each of the 3 analyses during the screening phase.

Exclusion Criteria:

Presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol- Spinal cord injury
History of surgical prostatectomy
Other exclusion criteria apply according to US Product Information

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Proportion of vardenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo after repeated use

Secondary Outcome Measures

Mean sperm concentration

Mean sperm count

Sperm morphology

Sperm motility

Reproductive hormones

Proportion of sildenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo and vardenafil after repeated use

Full Information

NCT ID

NCT00655590

First Posted

April 4, 2008

Last Updated

December 26, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00655590

Brief Title

Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

Official Title

A Randomized, Double-blind, Placebo Controlled, Parallel Arm, Multicenter Trial Assessing the Effect of Daily Treatment of Vardenafil 20 mg or Sildenafil 100 mg Compared to Placebo on Spermatogenesis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

5. Study Description

Brief Summary

Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile Dysfunction, Sildenafil, Vardenafil, Spermatogenesis, Sperm concentration, Sperm count, Morphology, Motility, Reproductive hormonal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

20 mg daily dosing

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

100 mg daily dosing

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebos

Primary Outcome Measure Information:

Title

Proportion of vardenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo after repeated use

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Mean sperm concentration

Time Frame

24 weeks

Title

Mean sperm count

Time Frame

24 weeks

Title

Sperm morphology

Time Frame

24 weeks

Title

Sperm motility

Time Frame

24 weeks

Title

Reproductive hormones

Time Frame

24 weeks

Title

Proportion of sildenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo and vardenafil after repeated use

Time Frame

24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male subjects or men with ED aged 25 - 64 Baseline sperm conc. of > 20 mio / ml- Normal World Health Organization A+B+C sperm mortality > 50%- Normal sperm morphology (WHO, 1992 manual criteria) > 30% and - 1.0 mL ejaculate volume at each of the 3 analyses during the screening phase. Exclusion Criteria: Presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol- Spinal cord injury History of surgical prostatectomy Other exclusion criteria apply according to US Product Information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

City

La Mesa

State/Province

California

ZIP/Postal Code

91942-3058

Country

United States

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92128

Country

United States

City

Torrance

State/Province

California

ZIP/Postal Code

90502-2004

Country

United States

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0330

Country

United States

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10016-4576

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212-2787

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

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