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

NCT01228071 | Completed Phase 3 Results

• 1 other identifier: EN3350-302
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

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%.

Conditions

Male Hypogonadism

Keywords

testosterone deficiency; hypogonadism

Outcome Measures

Primary Outcomes (3)

• Time to Target Eugonadal Range

  The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.

  24 hours

• Time to Steady State (SS)

  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.

  14 days

• Gel Drying Time

  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.

  1 day; drying time measured following gel application on Day 14

Study Arms (1)

40 mg daily dose of testosterone gel 2%

EXPERIMENTAL

testosterone gel 2%

Drug: testosterone gel 2%

Interventions

testosterone gel 2% DRUG

40 mg testosterone gel 2%

Also known as: EN3350

40 mg daily dose of testosterone gel 2%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 18 to 65 years.
• 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
• Have a body mass index (BMI) ≥22 kg/m2 and ≤35 kg/m2.
• Have a hematocrit level ≤50% at screening
• 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.
• Is able to understand and give written informed consent

You may not qualify if:

• 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.
• Acute or chronic renal impairment \[(Cr ≥ 1.5x ULN (upper limit of normal)\].
• Acute or chronic hepatic impairment will be excluded.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>2.5 × ULN (upper limit of normal).
• Clinically significant, abnormal, baseline laboratory result(s), which in the opinion of the Investigator affect(s) the subject's suitability for the trial.
• History of, or any existing, clinically significant cardiac disease (New York Heart Association \[NYHA\] Class III and IV).
• Clinically significant electrocardiogram (ECG) abnormalities such as QTcB or QTcF ≥450 msec; or QTc ≥480 msec in subjects with bundle branch block.
• Prostate specific antigen (PSA) level \>4 ng/mL.
• An abnormality on digital rectal examination deemed to be suspicious or worrisome for cancer, such as a nodule or asymmetric induration.
• Severe symptomatic benign prostatic hyperplasia or International Prostate Symptom Score (IPSS) \>19 (at screening).
• 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.
• Current eczema, psoriasis, sunburn, or any other clinically significant skin condition at the application site.
• Current abrasions at site of application.
• 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.
• Known to be sensitive and/or has had an adverse skin reaction to testosterone hormone replacement therapy or topical products containing alcohol.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (8)

Quality of Life Medical & Research Center

Tucson, Arizona, 85712, United States

Location

Connecticut Clinical Research

Middlebury, Connecticut, 06762, United States

Location

Compass Research East, LLC

Oviedo, Florida, 32765, United States

Location

Southeastern Research Group, Inc.

Tallahassee, Florida, 32308, United States

Location

Men's Health Boston

Brookline, Massachusetts, 02445, United States

Location

Tory Internal Medicine, PC

Troy, Michigan, 48098, United States

Location

Matrix Research, LLC

Greer, South Carolina, 29650, United States

Location

Cetero Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Eunuchism; Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceutical, Inc.

clinicalsite.inquiries@endo.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 5, 2017
• Results First Posted: July 22, 2013

Record last verified: 2017-09

Locations

US (8)