Erectile DysfunctionPhase 4NCT00106392

A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

A Phase 4 study testing Tacrolimus in people with Erectile Dysfunction and Prostate Cancer, run by Astellas Pharma Inc at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy. Read more about this study

Who is it for?: Ages Up to 65 years, men only
Conditions the study is for: Erectile Dysfunction, Prostate Cancer
What is being tested?: Tacrolimus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 131 participants
Where: 6 sitesUnited States
Study dates: Feb 2005to Nov 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 65 years
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Who cannot join

Patient is > 65 years of age
Patient has been diagnosed with Type 1 or Type 2 diabetes
Patient is actively smoking on a daily basis

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Ann Arbor, Michigan, 48109
Study site
Cleveland, Ohio, 44195
Study site
Houston, Texas, 77030
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10016
Study site
New York, New York, 10021

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Read the detailed description

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Conditions: Erectile Dysfunction, Prostate Cancer
Being tested: Tacrolimus, Placebo
Keywords: Treatment effectiveness, Treatment efficacy, Investigational, Therapies, Immunosuppressant, Erectile dysfunction, Prostatectomy
Medical subject headings: Erectile Dysfunction, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TacrolimusDrug
Also called Prograf, FK506
oral
PlaceboDrug
oral

Study groups in NCT00106392
Study group	Role	What they receive
Tacrolimus	Experimental	Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up. Receives: Drug: Tacrolimus
Placebo	Placebo comparator	Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Erectile Function Domain Score Between Treated and Untreated Groups
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
Measured: 18 months

Secondary outcomes (5)

Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.
Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months.
Measured: 24 months
Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.
Measured: 24 months
Percentage of Patients Considered Successful Responders to Impotence Medications
Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.
Measured: 24 months
Time to Achieve Response to Impotence Medications
Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.
Measured: 24 months
Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire
Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Nov 2008

First posted24 Mar 2005 (estimated)
Study startFeb 2005
Primary completionApr 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00106392
Sponsor's protocol ID: 20-03-001
Status last verified: Nov 2010
First submitted: 23 Mar 2005
Last updated: 23 Nov 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009.
PubMed 30224019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy
ClinicalTrials.gov ID: NCT00106392
Acronym / sponsor ID: 20-03-001
Conditions: Erectile Dysfunction, Prostate Cancer
Keywords: Treatment effectiveness, Treatment efficacy, Investigational, Therapies, Immunosuppressant, Erectile dysfunction, Prostatectomy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Apr 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 24 Mar 2005 (estimated)
Results: Posted 28 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

Detailed description

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tacrolimus	Experimental	Drug: TacrolimusPreoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
Placebo	Placebo comparator	Drug: PlaceboPreoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Who may qualify

Ages: Up to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer.

Key exclusion criteria (3 listed)

Patient is > 65 years of age
Patient has been diagnosed with Type 1 or Type 2 diabetes
Patient is actively smoking on a daily basis

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
TacrolimusAlso: Prograf, FK506oral	Drug	Tacrolimus
Placebooral	Drug	Placebo

Primary outcome

Erectile Function Domain Score Between Treated and Untreated Groups
Time frame: 18 months
Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

5 secondary outcomes

Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score
Time frame: 24 months
Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score
Time frame: 24 months
Percentage of Patients Considered Successful Responders to Impotence Medications
Time frame: 24 months
Time to Achieve Response to Impotence Medications
Time frame: 24 months
Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire
Time frame: 24 months

Results and safety

Results posted to the registry on 28 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tacrolimus	62	36
Placebo	69	42

Primary outcome: Erectile Function Domain Score Between Treated and Untreated Groups

Time frame: 18 months. Median (Full Range). Unit: Erectile Function Domain Score

Measure	Tacrolimus n = 32	Placebo n = 38
Value	18.0 (1.0 to 30.0)	23.5 (4.0 to 30.0)

Tacrolimus vs Placebo: p = 0.111, Wilcoxon (Mann-Whitney)

Population analysed: The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety. Only participants with complete IIEF questionnaire data at 18 months are included in the calculation.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and AEs as defined below were collected through month 6.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tacrolimus	1 of 59 (1.7%)	7 of 59 (11.9%)	Not reported
Placebo	0 of 65 (0%)	5 of 65 (7.7%)	Not reported

Limitations and caveats (from the sponsor): Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30224019Mulhall JP, Klein EA, Slawin K, Henning AK, Scardino PT. A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Utility of Tacrolimus (FK506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Prostatectomy. J Sex Med. 2018 Sep;15(9):1293-1299. doi: 10.1016/j.jsxm.2018.07.009.
Link to prescribing informationLink provided by the sponsor.

Related trials for Erectile Dysfunction

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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.

Central Contact study director

Astellas Pharma US, Inc.

6 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 Tacrolimus in people with Erectile Dysfunction and Prostate Cancer, run by Astellas Pharma Inc at 6 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 1 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 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Yes. Results are posted in the registry (first posted 28 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Erectile Function Domain Score Between Treated and Untreated Groups (time frame: 18 months). 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 NCT00106392, which also lists 1 linked publication.

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 23 Nov 2010.