A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

Ferring

Status and phase: Completed; Phase 3

Conditions: Adult Male Hypogonadism

Treatments: Drug: Testosterone gel (FE 999303)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665599

000023

Details and patient eligibility

About

This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Enrollment: 180 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males between 18-75 years of age
2. Two screening serum testosterone values less than 300 ng/dL
3. One or more symptoms of testosterone deficiency

Exclusion criteria

1. Previous use of the investigational product
2. Use of any investigational product within 30 days prior to screening and during the study
3. BMI less than 18 kg/m^2 or more than 35 kg/m^2
4. Prostatic mass(es)
5. Generalized skin irritation or skin disease
6. Lower urinary tract obstruction
7. Myocardial infarction or cerebrovascular accident in the last 6 months
8. Unstable angina or congestive heart failure
9. Thromboembolic disorders
10. Sleep apnea
11. Hyperparathyroidism or uncontrolled diabetes
12. Untreated moderate to severe depression
13. History of testicular, prostate, or breast cancer
14. HIV, Hepatitis B, or Hepatitis C positive
15. PSA more or equal to 3 ng/mL
16. Use of any medications that could be considered anabolic
17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
18. Chronic use of any drug of abuse
19. Involvement in a sport in which there is a screening for anabolic steroids
20. Not willing to use adequate contraception during the study
21. Partner is pregnant and/or breast feeding
22. Partner has a history of breast, uterine or ovarian cancer

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Testosterone gel (FE 999303)

Experimental group

Description:

Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.

Treatment:

Drug: Testosterone gel (FE 999303)