Clinical trial NCT01228071: Time to Eugonadal Range, Time to Steady State and Drying Time
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Male Hypogonadism
Keywords: testosterone deficiency
hypogonadism
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Time to Target Eugonadal Range
timeFrame: 24 hours
measure: Time to Steady State (SS)
timeFrame: 14 days
measure: Gel Drying Time
timeFrame: 1 day; drying time measured following gel application on Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center
state: Arizona
city: Middlebury
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: Oviedo
country: United States
facility: Compass Research East, LLC
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Research Group, Inc.
state: Florida
city: Brookline
country: United States
facility: Men's Health Boston
state: Massachusetts
city: Troy
country: United States
facility: Tory Internal Medicine, PC
state: Michigan
city: Greer
country: United States
facility: Matrix Research, LLC
state: South Carolina
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
References: