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

Phase 2

Completed

Conditions: Hypogonadal Males

Interventions: Drug: Testosterone Gel (FE 999303)

Registration Number: NCT01464879

Lead Sponsor: Ferring Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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
Untreated depression
Subject with a partner who is pregnant or will not use contraception

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Testosterone 2.50 mL (applicator)	Testosterone Gel (FE 999303)	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.
Testosterone 3.75 mL (applicator)	Testosterone Gel (FE 999303)	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.
Testosterone 1.25 mL (applicator)	Testosterone Gel (FE 999303)	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.
Testosterone 2.50 mL (hand)	Testosterone Gel (FE 999303)	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.

Primary Outcome Measures

Name	Time	Method
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.	Days 15-21, Days 22-28 & Days 29-35	Descriptive statistics was used to present the outcome results.

Secondary Outcome Measures

Name	Time	Method
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 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)	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 Minimum Observed Concentration (Tmin)	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 AUCτ	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand