Erectile DysfunctionPhase 4NCT00655590
Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) and Sildenafil in people with Erectile Dysfunction, run by Bayer at 18 sites in United States.
Trial summary
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function Read more about this study
- Who is it for?
- Ages 25 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Levitra (Vardenafil, BAY38-9456) and Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2005to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Ann Arbor, Michigan, 48109-0330
Study site
Aventura, Florida, 33180
Study site
Beverly Hills, California, 90212
Study site
Cincinnati, Ohio, 45212-2787
Study site
Great Neck, New York, 11021
Study site
La Mesa, California, 91942-3058
Study site
Laguna Hills, California, 92653
Study site
Minneapolis, Minnesota, 55455
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10016-4576
Study site
Phoenix, Arizona, 85023
Study site
Rochester, Minnesota, 55905
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92128
Study site
Tempe, Arizona, 85282
Study site
Torrance, California, 90502-2004
Study site
Van Nuys, California, 91405
Study site
Waterbury, Connecticut, 06708
About this study
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
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
- Conditions
- Erectile Dysfunction
- Being tested
- Levitra (Vardenafil, BAY38-9456), Sildenafil, Placebo
- Keywords
- Erectile Dysfunction, Sildenafil, Vardenafil, Spermatogenesis, Sperm concentration, Sperm count, Morphology, Motility, Reproductive hormonal
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
20 mg daily dosing
SildenafilDrug
100 mg daily dosing
PlaceboDrug
Matching placebos
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Active comparator | Not described Receives: Drug: Sildenafil |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (6)
Mean sperm concentration
Measured: 24 weeks
Mean sperm count
Measured: 24 weeks
Sperm morphology
Measured: 24 weeks
Sperm motility
Measured: 24 weeks
Reproductive hormones
Measured: 24 weeks
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655590
- Sponsor's protocol ID
- 11520
- Status last verified
- Dec 2014
- First submitted
- 4 Apr 2008
- Last updated
- 30 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00655590
- Acronym / sponsor ID
- 11520
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Sildenafil, Vardenafil, Spermatogenesis, Sperm concentration, Sperm count, Morphology, Motility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Active comparator | Drug: Sildenafil |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456)20 mg daily dosing | Drug | Arm 1 |
| Sildenafil100 mg daily dosing | Drug | Arm 2 |
| PlaceboMatching placebos | Drug | Arm 3 |
Primary outcome
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
6 secondary outcomes
Mean sperm concentration
Time frame: 24 weeks
Mean sperm count
Time frame: 24 weeks
Sperm morphology
Time frame: 24 weeks
Sperm motility
Time frame: 24 weeks
Reproductive hormones
Time frame: 24 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levitra (Vardenafil, BAY38-9456) and Sildenafil in people with Erectile Dysfunction, run by Bayer at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.