Erectile DysfunctionPhase 4NCT00382135
A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg
A Phase 4 study testing tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil. Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Dec 2005
- 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 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects or men with mild erectile dysfunction
- At least 45 years of age
- With specified semen characteristics.
Who cannot join
- Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
- A history of certain endocrine or hormonal abnormalities
- A history of significant testicular/genital abnormalities
- Any significant reproductive abnormality identified at the start of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bothell, Washington
About this study
Official title: An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.
- Conditions
- Erectile Dysfunction
- Being tested
- tadalafil, placebo
- Keywords
- Impotence, erectile dysfunction, semen, sperm, Healthy male volunteers, men with mild erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafilDrug
Also called LY450190, Cialis, IC351
20mg tadalafil tablet taken by mouth once a day for 40 weeks
placeboDrug
Placebo tablet taken by mouth once a day for 40 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo tablet Receives: Drug: placebo |
| 2 | Active comparator | 20 mg tadalafil tablet Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sperm production measured at baseline and after 9 months of treatment.
Measured: 40 weeks
Secondary outcomes (1)
Changes in other semen characteristics and reproductive hormones.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startNov 2003
- Study completionDec 2005
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 Eli Lilly and CompanyThe 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
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382135
- Sponsor's protocol ID
- 7011
- Other IDs
- H6D-MC-LVFE
- Status last verified
- Oct 2007
- First submitted
- 26 Sep 2006
- Last updated
- 25 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Semen Characteristics After 40 Weeks Daily Dosing With 20 mg Tadalafil
- ClinicalTrials.gov ID
- NCT00382135
- Acronym / sponsor ID
- 7011
- Conditions
- Erectile Dysfunction
- Keywords
- Impotence, erectile dysfunction, semen, sperm, Healthy male volunteers, men with mild erectile dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation
- Study start
- Nov 2003
- Study completion
- Dec 2005 (actual)
- First posted
- 28 Sep 2006 (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.
This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboplacebo tablet |
| 2 | Active comparator | Drug: tadalafil20 mg tadalafil tablet |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male subjects or men with mild erectile dysfunction
- At least 45 years of age
- With specified semen characteristics.
Key exclusion criteria (4 listed)
- Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
- A history of certain endocrine or hormonal abnormalities
- A history of significant testicular/genital abnormalities
- Any significant reproductive abnormality identified at the start of the study.
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 |
|---|---|---|
| tadalafilAlso: LY450190, Cialis, IC35120mg tadalafil tablet taken by mouth once a day for 40 weeks | Drug | 2 |
| placeboPlacebo tablet taken by mouth once a day for 40 weeks | Drug | 1 |
Primary outcome
Change in sperm production measured at baseline and after 9 months of treatment.
Time frame: 40 weeks
1 secondary outcome
Changes in other semen characteristics and reproductive hormones.
Time frame: 40 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 25 Oct 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tadalafil in people with Erectile Dysfunction, run by Eli Lilly and Company at 1 site 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 3 inclusion and 4 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 25 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in sperm production measured at baseline and after 9 months of treatment. (time frame: 40 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 25 Oct 2007.