Time to Eugonadal Range, Time to Steady State and Drying Time

NCT ID: NCT01228071

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

Brief Summary

This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.

Detailed Description

Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application

Conditions

Male Hypogonadism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

40 mg daily dose of testosterone gel 2%

testosterone gel 2%

Group Type: EXPERIMENTAL

testosterone gel 2%

Intervention Type: DRUG

40 mg testosterone gel 2%

Interventions

testosterone gel 2%

40 mg testosterone gel 2%

Intervention Type: DRUG

Other Intervention Names

EN3350

Eligibility Criteria

Inclusion Criteria

1. Men aged 18 to 65 years.

2. Have a diagnosis of primary or secondary hypogonadism with a:

• Single morning serum total testosterone concentration <250 ng/dL or
• Two (2) consecutive morning serum total testosterone concentrations <300 ng/dL (determined at least 1 week apart during a 3 week screening period) Total serum testosterone sampling must occur between 7 AM and 11 AM at screening

3. Have a body mass index (BMI) ≥22 kg/m2 and ≤35 kg/m2.

4. Have a hematocrit level ≤50% at screening

5. Use of reliable contraception for subjects who have sexual partners of childbearing potential (women not of childbearing potential are defined as postmenopausal, ie, amenorrhea ≥1 year or permanently sterile). Reliable methods of contraception are:

• Barrier type devices (eg, condom, female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
• Intra-uterine devices.
• Oral, injectable, transdermal or implantable hormonal contraceptives.

6. Is able to understand and give written informed consent

Exclusion Criteria

1. Severe concomitant illness, which in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial.

2. Acute or chronic renal impairment [(Cr ≥ 1.5x ULN (upper limit of normal)].

3. Acute or chronic hepatic impairment will be excluded.

4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 × ULN (upper limit of normal).

5. Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the subject's suitability for the trial.

6. History of, or any existing, clinically significant cardiac disease (New York Heart Association [NYHA] Class III and IV).

7. Clinically significant electrocardiogram (ECG) abnormalities such as QTcB or QTcF ≥450 msec; or QTc ≥480 msec in subjects with bundle branch block.

8. Prostate specific antigen (PSA) level >4 ng/mL.

9. An abnormality on digital rectal examination deemed to be suspicious or worrisome for cancer, such as a nodule or asymmetric induration.

10. Severe symptomatic benign prostatic hyperplasia or International Prostate Symptom Score (IPSS) >19 (at screening).

11. Sleep apnea which is untreated, or subjects with sleep apnea which is treated (including c-PAP treatment) but in the opinion of the investigator has been clinically unstable during the 3 months prior to screening.

12. Current eczema, psoriasis, sunburn, or any other clinically significant skin condition at the application site.

13. Current abrasions at site of application.

14. Malignancy (or suspected malignancy) of any type except a basal cell carcinoma. Subjects with a history of malignancy must have a disease free status ≥5 years prior to starting study treatment. Subjects who have had prostate or breast cancer are not permitted to participate in the study.

15. Known to be sensitive and/or has had an adverse skin reaction to testosterone hormone replacement therapy or topical products containing alcohol.

16. Actively or potentially trying to start a family or requiring fertility treatment or with a spouse/partner who is pregnant.

17. Participated in any experimental drug or device study within 30 days prior to starting study treatment.

18. History of alcohol or substance abuse within the last year.

19. Taking opioids for any reason within 3 days of screening

20. Receiving the following medications:

• Androgen treatments.
• Androgen antagonists.
• Application of any lotions, ointments, or steroids to the application site.
• 5alpha-reductase inhibitors (eg, finasteride, dutasteride).

21. Any subjects receiving testosterone hormone replacement treatments must abide by the indicated washout period prior to screening total serum testosterone measurement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quality of Life Medical & Research Center

Tucson, Arizona, United States

Connecticut Clinical Research

Middlebury, Connecticut, United States

Compass Research East, LLC

Oviedo, Florida, United States

Southeastern Research Group, Inc.

Tallahassee, Florida, United States

Men's Health Boston

Brookline, Massachusetts, United States

Tory Internal Medicine, PC

Troy, Michigan, United States

Matrix Research, LLC

Greer, South Carolina, United States

Cetero Research

San Antonio, Texas, United States

Countries

United States

Other Identifiers

EN3350-302

Identifier Type: -

Identifier Source: org_study_id