A Study of Tadalafil and Sildenafil in Men With Erectile... | NCT01352507

NCT01352507

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
H6D-CR-LVIZ	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Tadalafil Drug: 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: Tadalafil Drug: Sildenafil

Name	Type	Description	Arm Group Labels	Other Names
Tadalafil	Drug	Administered Orally	Sildenafil then Tadalafil Tadalafil then Sildenafil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ	PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, "For the treatment preference you selected in Q1, what is your degree of preference?". Choices were moderate or strong.	Week 18

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Have a history of significant central nervous system injuries (including stroke and spinal cord injury) within the last 6 months.
Have a history of human immunodeficiency virus (HIV) infection.
Have a condition that in the opinion of the investigator would interfere with the patient's ability to provide informed consent or comply with study instructions, would place the patient at increased risk, or might confound the interpretation of study results.
Currently receive treatment with nitrates, alpha [1]-adrenergic blockers (such as doxazosin), cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia™ or Proscar® or Avodart® [dutasteride]).
Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Patients who are currently taking TCM for ED treatment within the last 30 days prior to study entry or planned concomitant administration of TCM for ED treatment during study enrolment.
Are currently enrolled in, or discontinued with the last 30 days from a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have been screen failures in other studies may be eligible if they satisfy the inclusion/exclusion criteria.
Have a history of loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption lactose intolerance.
Are currently in a sexual relationship with a female of child-bearing potential where no form of birth control is being used. A female of child-bearing potential is a female who is not surgically or chemically sterilized and who is between menarche and 1-year post menopause.
Are currently in or are planning to be in a sexual relationship with a pregnant female or are currently in a relationship where either partner is actively trying to conceive.

Contacts/Locations Module

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	Tadalafil Then Sildenafil	20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).
FG001	Sildenafil Then Tadalafil	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 was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED.

Periods

Title

Milestones

Reasons Not Completed

Treatment Period 1

Type	Comment	Milestone Data
STARTED		FG000190 subjects FG001193 subjects
Received Treatment		FG000182 subjects FG001188 subjects
COMPLETED		FG000176 subjects FG001184 subjects
NOT COMPLETED		FG00014 subjects FG0019 subjects

Type	Comment	Reasons
Adverse Event		FG0003 subjects FG0010 subjects
Lost to Follow-up		FG0003 subjects FG001

Washout Period

Type	Comment	Milestone Data
STARTED		FG000176 subjects FG001184 subjects
COMPLETED		FG000176 subjects FG001

Treatment Period 2

Type	Comment	Milestone Data
STARTED		FG000176 subjects FG001183 subjects
Received Treatment		FG000173 subjects FG001

Extension Phase

Type	Comment	Milestone Data
STARTED		FG000164 subjects FG001173 subjects
COMPLETED		FG000164 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Tadalafil Then Sildenafil	20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments. At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Week 18

ID	Title	Description
OG000	All Randomized Participants	Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tadalafil (Treatment Periods)	20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Palpitations	Cardiac disorders	MedDRA 15.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D007172	Erectile Dysfunction

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Intervention Browse Module

ID	Term
D000068581	Tadalafil
D000068677	Sildenafil Citrate

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Masking Info

EG0001 events1 affected363 at risk

EG0011 events1 affected361 at risk

EG0020 events0 affected231 at risk

EG0030 events0 affected106 at risk