Brief Summary

The primary objective of this study is to evaluate whether, after two 8-week treatment periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg) tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each and an extension phase of 8 weeks, for a total of 24 weeks.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

383

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Jun 2011

Shorter than P25 for phase_4

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

May 10, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed

20 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

10 months until next milestone

Results Posted

Study results publicly available

April 26, 2013

Completed

Last Updated

April 26, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

May 10, 2011

Results QC Date

March 13, 2013

Last Update Submit

March 13, 2013

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the "Phosphodiesterase 5 Inhibitor Treatment Preference" Questionnaire (PITPQ)
PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.
Week 18

Secondary Outcomes (12)

Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ
Week 18
Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain
Baseline, Week 8, and Week 18
Change in Sexual Encounter Profile (SEP) Question 2
Baseline, Week 8, and Week 18
Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain
Baseline, Week 8, and Week 18
Drug Attributes Questionnaire (DRAQ) at Week 18
Week 18
+7 more secondary outcomes

Study Arms (2)

Tadalafil then Sildenafil

EXPERIMENTAL

20 mg tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There is a washout period of 7-10 days between treatments. At the end of the two 8-week treatment periods, participants will be allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).

Drug: TadalafilDrug: Sildenafil

Sildenafil then Tadalafil

ACTIVE COMPARATOR

100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There is a washout period of 7-10 days between treatments. At the end of the two 8-week treatment periods, participants will be allowed to enter an 8-week extension phase on their preferred medication for ED.

Drug: TadalafilDrug: Sildenafil

Interventions

TadalafilDRUG

Administered Orally

Also known as: Cialis, LY450190

Sildenafil then TadalafilTadalafil then Sildenafil

SildenafilDRUG

Administered Orally

Sildenafil then TadalafilTadalafil then Sildenafil

Eligibility Criteria

Age18 Years - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Study Subjects
Are able to read, understand and provide signed informed consent.
Have a history ED of any etiological classification (psychogenic, organic, or mixed) and any severity for at least 3 months.
Have never taken any phosphodiesterase 5 (PDE5) inhibitor for the treatment of ED.
Anticipate having the same female sexual partner during the study for recording responses to efficacy questionnaires. If a qualifying participant has more than one female partner during the study, the participant will not be excluded from the trial. However, the participant will be required to respond to the questionnaires based on his sexual interactions with only one of these partners.
Make at least 4 sexual intercourse attempts, with the female sexual study partner, during the 4-week run-in period and during the final 4 weeks of each 8-week treatment period.
Not use any ED treatment including the use of herbal therapy and traditional Chinese medicine (TCM) for the treatment of ED other than study medication at any time during the study and for 96 hours after study completion.
Partners
Are female, at least 18 years of age at screening and will have the same male study subject as her sexual partner during the study.
Are able to read, understand and provide signed informed consent.
Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase and during the final 4 weeks of each 8-week treatment period.
Willing to participate in recording responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in this study.

You may not qualify if:

Present with ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
Have a history of radical prostatectomy, or other pelvic surgery with subsequent failure to achieve erection.
Have a history of penile implant.
Have a clinically significant penile deformity in the opinion of the investigator.
Exhibit evidence of clinically significant renal insufficiency as determined by the investigator, or defined as receiving renal dialysis or having an estimated creatinine clearance of less than (\<)30 milliliters per minute (mL/minute) at screening, as calculated by the local laboratory using the Cockcroft-Gault formula.
Exhibit evidence of active symptomatic hepatobiliary disease at Visit 1.
Exhibit Hemoglobin A1c greater than (\>) 11 percent (%) at screening, in patients with a history of diabetes mellitus of any type.
Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
Have met the criteria for unstable angina within 6 months before screening, or have a history of myocardial infarction or coronary artery bypass graft surgery within 90 days before screening, or percutaneous coronary intervention within 90 days before screening.
Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate \>100 bpm) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate \>100 beats per minute (bpm) for greater than or equal \[≥\] to 30 seconds) despite medical or device therapy, or use an internal cardioverter-defibrillator.
Have a history of sudden cardiac arrest despite medical or device therapy.
Exhibit any evidence of congestive heart failure within 6 months before screening.
Have had a new or significant cardiac conduction defect within 90 days before screening.
Exhibit systolic blood pressure \>170 or \<90 milliliters of mercury (mm Hg) or diastolic blood pressure \>100 or \<50 mm Hg at screening, or have a history of malignant hypertension.
Have retinitis pigmentosa.
+11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (9)

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.

Beijing, 100853, China

Location

Changsha, 410008, China

Location

Hangzhou, 310003, China

Location

Nanjing, 210008, China

Location

Shanghai, 200080, China

Location

Shenzhen, 518036, China

Location

Tianjin, 300211, China

Location

Wuhan, 430030, China

Location

Xi'an, 710004, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

TadalafilSildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesPurines

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 12, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

April 26, 2013

Results First Posted

April 26, 2013

Record last verified: 2013-03

Locations

CN(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Tadalafil then Sildenafil

Sildenafil then Tadalafil

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations