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Completed

NCT Number: NCT00655590

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

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

25 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

20 mg daily dosing

Sildenafil

Drug

100 mg daily dosing

Placebo

Drug

Matching placebos

Primary outcomes

  1. 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 outcomes

  1. Mean sperm concentration

    Time frame: 24 weeks

  2. Mean sperm count

    Time frame: 24 weeks

  3. Sperm morphology

    Time frame: 24 weeks

  4. Sperm motility

    Time frame: 24 weeks

  5. Reproductive hormones

    Time frame: 24 weeks

  6. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 10, 2008
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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