A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

NCT01464879 | Completed Phase 2 Results

• 1 other identifier: 000024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application

Conditions

Hypogonadal Males

Outcome Measures

Primary Outcomes (1)

• Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.

  Descriptive statistics was used to present the outcome results.

  Days 15-21, Days 22-28 & Days 29-35

Secondary Outcomes (13)

• Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.

  Days 1-7

• Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)

  Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

• Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)

  Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

• Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)

  Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

• Pharmacokinetics of Total Testosterone and DHT Measuring Cavg

  Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator

Study Arms (4)

Testosterone 2.50 mL (hand)

EXPERIMENTAL

Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.

Drug: Testosterone Gel (FE 999303)

Testosterone 1.25 mL (applicator)

EXPERIMENTAL

Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days.

Drug: Testosterone Gel (FE 999303)

Testosterone 2.50 mL (applicator)

EXPERIMENTAL

Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.

Drug: Testosterone Gel (FE 999303)

Testosterone 3.75 mL (applicator)

EXPERIMENTAL

Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days.

Drug: Testosterone Gel (FE 999303)

Interventions

Testosterone Gel (FE 999303) DRUG

Testosterone 1.25 mL (applicator); Testosterone 2.50 mL (applicator); Testosterone 2.50 mL (hand); Testosterone 3.75 mL (applicator)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-75
• History of hypogonadism
• In good health based on medical history, physical examination, and clinical laboratory tests
• Serum testosterone deficiency
• One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
• Body mass index (BMI) between 18 and 35 kg/m\^2
• All screening lab tests within 20% of the normal range (exceptions are liver function tests)
• HIV, Hepatitis B and C negative

You may not qualify if:

• Previous use of FE 999303
• Prostate cancer
• Breast carcinoma, patient or partner
• Palpable prostatic mass(es)
• Serum PSA levels ≥3 ng/dL
• Chronic use of any drug of abuse
• Lower urinary tract obstruction
• Clinically significant anemia or renal dysfunction
• Cardiovascular disease
• Hyperparathyroidism or uncontrolled diabetes
• Generalized skin irritation or significant skin disease
• Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
• Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
• Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
• Sleep apnea

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

AccuMed Research Associates

Garden City, New York, United States

Location

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 4, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 13, 2017
• Results First Posted: July 28, 2017

Record last verified: 2017-08

Locations

US (1)