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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01228071
First received: October 22, 2010
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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%.


Condition Intervention Phase
Male Hypogonadism
Drug: testosterone gel 2%
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Time to Target Eugonadal Range [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.

  • Time to Steady State (SS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.

  • Gel Drying Time [ Time Frame: 1 day; drying time measured following gel application on Day 14 ] [ Designated as safety issue: No ]
    Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.


Enrollment: 34
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg daily dose of testosterone gel 2%
testosterone gel 2%
Drug: testosterone gel 2%
40 mg testosterone gel 2%
Other Name: EN3350

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228071

Locations
United States, Arizona
Quality of Life Medical & Research Center
Tuscon, Arizona, United States, 85712
United States, Connecticut
Connecticut Clinical Research
Middlebury, Connecticut, United States, 06762
United States, Florida
Compass Research East, LLC
Oviedo, Florida, United States, 32765
Southeastern Research Group, Inc.
Tallahassee, Florida, United States, 32308
United States, Massachusetts
Men's Health Boston
Brookline, Massachusetts, United States, 02445
United States, Michigan
Tory Internal Medicine, PC
Troy, Michigan, United States, 48098
United States, South Carolina
Matrix Research, LLC
Greer, South Carolina, United States, 29650
United States, Texas
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01228071     History of Changes
Other Study ID Numbers: EN3350-302
Study First Received: October 22, 2010
Results First Received: March 27, 2013
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
testosterone deficiency
hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014