A study in men with low testosterone to measure the effect of testosterone solution on testosterone levels, sex drive and energy.

• Register: EUCTR
• Last refreshed on: 23 October 2023
• Main ID: EUCTR2012-004866-16-ES
• Date of registration: 20/05/2013
• Prospective Registration: Yes
• Primary sponsor: Lilly S.A.
• Public title: A study in men with low testosterone to measure the effect of testosterone solution on testosterone levels, sex drive and energy.
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men.
• Date of first enrolment: 21/06/2013
• Target sample size: 618
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004866-16
• 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: yes Other trial design description: Open label extension phase If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Brazil, Canada, Germany, Italy, Korea, Republic of, Puerto Rico, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
[1] Able to read, understand, and provide signed informed consent before starting trial activities related to Study TSAT (including discontinuing [washout] testosterone replacement therapy or other therapies prior screening).
[2] Male at least 18 years of age at the time of screening.
[3] Total testosterone level <300ng/dL (10.4 nmol/L) obtained at each of the 2 screening visits, performed at least 1 week apart (morning lab collection required between 0700 and 1100 hours).
[4] Currently have at least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive, based on patient reported history and opinion of the investigator.
[5] If the individual is taking lipid-lowering medications, insulin, antidepressants, anxiolytics, or therapy for benign prostatic hyperplasia (BPH), their dose must be stable for at least 3 months prior to screening in the opinion of the investigator.
[6] PSA <4 ng/ml at the time of screening.
[7] Agree to not start any new medication for erectile dysfunction (ED) or libido during the study at any point from screening to the end of the double-blind portion of the study (including herbal and over-the-counter medications).
[8] If the individual is receiving testosterone replacement therapy and is willing to discontinue testosterone replacement therapy to enter the study, their screening testosterone level cannot be checked until at least 14 days after discontinuing oral or topical therapies (or at least 30 days for patients using short-acting intramuscular [IM] therapies [testosterone cypionate or testosterone enanthate] or at least 6 months for patients using long-acting IM testosterone undecanoate).
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 525
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93

Exclusion criteria:
[1] Sexual partner who is, or becomes, pregnant at any time during the study.
[2] Use of long-acting IM testosterone undecanoate or testosterone pellets in the 6-month period prior to screening.
[3] BMI >37kg/m2 at screening.
[4] Severe lower urinary tract symptoms as well as significant prostate enlargement to the extent that the investigator does not believe that the patient should receive testosterone replacement therapy.
[5] Prolactin lab test result of >30 ng/dL at screening.
[6] HbA1c >11% at screening.
[7] Hematocrit ?50% at screening. For sites located at geographic elevations ?4500 feet (approximately 1370 meters), patients will be excluded with hematocrit >54% at screening, according to investigator discretion. If any patient at any site regardless of geographic elevation develops hematocrit >54% at later study visits investigational product will be discontinued immediately.
[8] Significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone and/or sunscreens.
[9] Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone.
[10] Dermatologic condition in underarm area that might interfere with testosterone absorption or be exacerbated by topical testosterone replacement therapy.
[11] Currently receiving treatment with cancer chemotherapy or antiandrogens.
[12] Current use of systemic glucocorticoids. Use of non-testosterone anabolic steroids within 12 months prior to screening.
[13] Competitive athletes involved in a sport in which they may be screened for anabolic steroids.
[14] History of use of estrogenizing agents within 12 months prior to screening.
[15] History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening.
[16] History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening.
[17] Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening.
[18] Current use of warfarin.
[19] History of frequent opioid use (>1 time/week) within 30 days prior to screening.
[20] Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine).
[21] History of drug, alcohol, or substance abuse within 6 months prior to screening, as assessed by the investigator.
[22] Have a history of significant central nervous system injuries or disease within 6 months prior to screening.
[23] Exhibit systolic blood pressure >170 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening, or have history of malignant hypertension.
[24] History of unstable angina or angina occurring during sexual intercourse in the last 6 months.
[25] History of any of the following coronary conditions within 90 days of screening:
a. myocardial infarction
b. coronary artery bypass graft surgery
c. percutaneous coronary intervention (angioplasty or stent placement)
[26] Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per minute [bpm]) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for ?30 seconds), or use an automatic internal cardioverter-defibrillator.
[27] Have a history of sudden cardiac arrest.
[28] Exhibit any evidence of congestive heart failure within 6 months prior to screening.
[29] Have had a new, significant cardiac conduction defect within 90

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

Health Condition(s) or Problem(s) studied

Male hypogonadism
MedDRA version: 14.1 Level: PT Classification code 10021011 Term: Hypogonadism male System Organ Class: 10014698 - Endocrine disorders

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Product Name: Testosterone Solution
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: TESTOSTERONE
Other descriptive name: Testosterone solution
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Cutaneous use

Primary Outcome(s)

Main Objective: The primary objective of the double blind phase is to compare the effect of testosterone solution vs. placebo on the proportion of hypogonadal men having a serum total testosterone concentration within the normal range (300 ? 1050 ng/dL) at the completion of 12 weeks of treatment.

The primary objective of the open-label extension phase is to assess the safety of testosterone solution for an additional 24 weeks in hypogonadal men using the following measures:
? Adverse events
? Clinical laboratory tests (including hematocrit)
? Prostate safety (prostate specific antigen [PSA] and digital rectal exam)
? International Prostate Symptom Score (IPSS)

Timepoint(s) of evaluation of this end point: Double blind phase:
12 weeks of treatment

Open-label extension phase:
Total of 36 weeks of treatment (12 weeks treatment during double-blind phase + 24 weeks treatment during open-label extension)

Primary end point(s): The primary endpoint of the double blind phase is to determine the proportion of men that have a serum total testosterone level within the normal range (300 ? 1050 ng/dL) at the completion of 12 weeks of treatment with testosterone solution.

The primary endpoint of the open-label extension is to assess long term safety by collecting the following measures:
? Adverse events
? Clinical laboratory tests (including hematocrit)
? Prostate safety (prostate specific antigen [PSA] and digital rectal exam)
? International Prostate Symptom Score (IPSS)
at the completion of the additional 24 weeks of treatment with testosterone solution . The measures will be compared to the baseline visit of the double-blind phase and the baseline visit of the open-label extension phase.

Secondary Objective: The secondary objectives of the double-blind phase are:
a) In patients with low sex drive, assess and compare the impact of testosterone solution vs. placebo on levels of sexual arousal, interest, and drive, as measured by change from baseline in scores on the Sexual Arousal, Interest, and Drive (SAID) Scale.
b) In patients with low energy, assess and compare the impact of testosterone solution vs. placebo on levels of energy as measured by change from baseline in scores on the Hypogonadism Energy Diary (HED).

Secondary Outcome(s)

Secondary end point(s): The secondary endpoints of the double blind phase are:

1. In patients with low sex drive, the change in levels of sexual arousal, interest and drive as assessed by a patient reported outcome tool, the SAID (Sexual Arousal, Interest and Drive) Scale at the completion of 12 weeks of treatment with testosterone solution.
2. In patients with low energy, the change in energy level as assessed by a patient reported outcome tool, the HED (Hypogonadism Energy Diary) at the completion of 12 weeks of treatment with testosterone solution.

Timepoint(s) of evaluation of this end point: 1. 4 weeks of treatment

2. 12 weeks of treatment

Secondary ID(s)

2012-004866-16-DE

I5E-MC-TSAT

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 14/05/2013
Contact:

Results

• Results available: Yes
• Date Posted: 15/05/2016
• Date Completed: 30/04/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004866-16/results