Phase IIIB, Double Blind, Placebo Controlled, International, Multicenter, Parallel Group Study, to Assess the Efficacy and Safety of Testim Gel in Combination with a Phosphodiesterase V Inhibitor (Tadalafil), in Male Patients with Low or Baseline Serum Testosterone Levels and Erectile Dysfunction - TESTIMED

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005060-92-GB

Enrollment

264

Registered

2006-05-05

Start date

2006-09-01

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To demonstrate that in patients with erectile dysfunction who have low or borderline baseline total testosterone levels, that Testim 50 mg Gel, indicated for male hypogonadism when testosterone deficiency has been confirmed, significantly improves the patient response to tadalafil (used to treat erectile dysfunction) using the Internal Index of Erectile Function (IIEF) scale.

Interventions

Trade Name: Testim 50 mg Gel Product Name: Testim 50 mg Gel Pharmaceutical Form: Gel INN or Proposed INN: Testosterone Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentratio

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Have ED defined as a score =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients having any contra-indication to tadalafil treatment: stroke within last 6 months, myocardial infarction within the last 90 days, unstable angina or angina occurring during sexual intercourse, New York Heart Association Class 2 or greater heart failure in the last 6 months, uncontrolled arrhythmias, hypotension (170/100 mm Hg), clinically significant renal (creatinine clearance 4 ng/mL), abnormal findings at the Digital Rectal Examination (DRE) 3. Patients with known hypersensitivity to tadalafil, testosterone or other drug with a similar chemical structure or any of the excipients 4. Patients having drug induced ED 5. Patients having poorly controlled diabetes defined by Glycosylated Haemoglobin (HbA1c)>10% 6. Patients having history of non-arteritic anterior ischaemic optic neuropathy 7. Patients having received any unlicensed drug within the previous 30 days 8. Patients requiring treatment during the study with drugs that are not permitted by the study protocol 9. Patients trying to have a baby or planning to in the study period. Adequate contraception such as contraceptive pill, intra uterine device, diaphragm or barrier method such as barrier contraceptive.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that in patients with erectile dysfunction (ED) who are found to have low ( (35 nmol/L, RBC, Hb, Htc, fasting glucose levels, HbA1c, serum PSA, Digital rectal exam, blood pressure, ECG, biochemistry	—

Countries

Belgium, Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026