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

• Register: EUCTR
• Last refreshed on: 13 October 2020
• Main ID: EUCTR2005-005060-92-GB
• Date of registration: 05/05/2006
• Prospective Registration: Yes
• Primary sponsor: Ipsen Pharma GmBH
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/09/2006
• Target sample size: 264
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005060-92
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have ED defined as a score < 26 in the "erectile function" module of the IIEF scale
2. Have a score <3 (sometimes) to both question 3 (successful penetration) and question 4 (successful maintenance of erection after penetration) of the IIEF scale
3. Have a serum total testosterone level <12 nmol/L (346 ng/dL) assayed on two samples drawn between 7 and 10 am on two separate days: -one at V1 visit performed by central lab; -one 10 to 14 days before V2 performed by central lab
4. Have not been treated with testosterone since the selection visit
5. Have not been treated with PDE5 inhibitors since the selection visit
6. Have kept the same female partner since the selection visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (<90/50 mm Hg) or uncontrolled hypertension (>170/100 mm Hg), clinically significant renal (creatinine clearance <30 mL/min) or hepatic insufficiency (Child-Pugh Class C), patients receiving organic nitrates
2. Patients having any contra-indication to testosterone therapy: breast carcinoma, prostate carcinoma, suspected prostate carcinoma (PSA > 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.


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

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
Concentration number: 50-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Transdermal use

Trade Name: Cialis 20 mg film-coated tablets
Product Name: Cialis 20 mg film-coated tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: tadalafil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): Primary Efficacy Endpoints-Percentage of patients with a response of 4 (most times) or 5 (almost always/always) to both question 3 (successful penetration) and question 4 (successful maintenance of erection after penetration) of the IIEF at 12 weeks or at endpoint

Primary Safety Endpoints-Adverse events, proportion of patients with serum testosterone levels >35 nmol/L, RBC, Hb, Htc, fasting glucose levels, HbA1c, serum PSA, Digital rectal exam, blood pressure, ECG, biochemistry

Main Objective: To demonstrate that in patients with erectile dysfunction (ED) who are found to have low (<8 nmol/L or 231 ng/dL) or (<12 nmol/L or 346 ng/dL) baseline total testosterone levels, Testim Gel significantly improves the patient response to tadalafil using the International Index of Erectile Function (IIEF) scale

Secondary Objective: To assess the safety of co-administering Testim Gel and tadalafil in the targeted patient population

To identify putative predictive factors of Testim Gel efficacy in the target population such as baseline total testosterone levels, bioavailable testosterone levels and androgen receptor Cystine Alanine Guanine (CAG) repeat number

Secondary ID(s)

2-79-00500-002

Ethics review

Status: Approved
Approval date: 10/10/2006
Contact:

Results

• Results available: Yes
• Date Posted: 27/01/2019
• Date Completed: 28/02/2007
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-005060-92/results