ImpotencePhase 3NCT00547183
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
A Phase 3 study testing tadalafil in people with Impotence, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Impotence
- 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
- 298 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to May 2005
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of erectile dysfunction for at least 3 months.
- Currently have diabetes mellitus of at least 3 months duration.
- Agree to not use any other ED treatment during the study.
- Anticipate the same female sexual partner for the study.
- Must be willing to make the required number of sexual attempts.
Who cannot join
- History of other primary sexual disorder
- Treatment with nitrates or potent CYP3A4 inhibitors
- Have a penile implant or clinically significant penile deformity
- History of certain heart problems
- Have kidney or liver problems
Trial locations and contacts
1 site in 1 country.
Germany1 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.
Genthin
About this study
Official title: A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction
Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.
- Conditions
- Impotence
- Being tested
- tadalafil, placebo
- 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
2.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
tadalafilDrug
Also called LY450190, Cialis, IC351
5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks
placeboDrug
Placebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | 2.5 mg tadalafil Receives: Drug: tadalafil |
| 3 | Active comparator | 5 mg tadalafil Receives: Drug: tadalafil |
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary
Measured: 12 weeks
Secondary outcomes (1)
Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startOct 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ImpotenceStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 298 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
- NCT00547183
- Sponsor's protocol ID
- 8702
- Other IDs
- H6D-MC-LVFZ
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2007
- Last updated
- 22 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
PubMed 24119319Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
PubMed 23035781
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil (2.5 mg and 5 mg) Administered Once Daily to Men With Diabetes Mellitus and Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00547183
- Acronym / sponsor ID
- 8702
- Conditions
- Impotence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- ICOS Corporation
- Study start
- Oct 2004
- Study completion
- May 2005 (actual)
- First posted
- 22 Oct 2007 (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.
Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: tadalafil2.5 mg tadalafil |
| 3 | Active comparator | Drug: tadalafil5 mg tadalafil |
| 1 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of erectile dysfunction for at least 3 months.
- Currently have diabetes mellitus of at least 3 months duration.
- Agree to not use any other ED treatment during the study.
- Anticipate the same female sexual partner for the study.
- Must be willing to make the required number of sexual attempts.
Key exclusion criteria (5 listed)
- History of other primary sexual disorder
- Treatment with nitrates or potent CYP3A4 inhibitors
- Have a penile implant or clinically significant penile deformity
- History of certain heart problems
- Have kidney or liver problems
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, IC3512.5 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks | Drug | 2 |
| tadalafilAlso: LY450190, Cialis, IC3515 mg tadalafil tablet taken by mouth once a day, no more than 1 dose a day, for 12 weeks | Drug | 3 |
| placeboPlacebo tablet taken by mouth once a day, no more than 1 dose per day, for 12 weeks | Drug | 1 |
Primary outcome
Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary
Time frame: 12 weeks
1 secondary outcome
Change in the GAQ, SEP, IIEF, SEAR, and RSE scores.
Time frame: 12 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 22 Oct 2007.
- Derived from this study: PubMed 24119319Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
- Derived from this study: PubMed 23035781Shabsigh R, Seftel AD, Kim ED, Ni X, Burns PR. Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline. J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
- 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 3 study testing tadalafil in people with Impotence, run by Eli Lilly and Company at 1 site in Germany.
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 5 inclusion and 5 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 22 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in the SEP diary (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00547183, which also lists 2 linked publications.
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 22 Oct 2007.