Clinical trial NCT01464879: A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
Official title: A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadal Males
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Days 15-21, Days 22-28 & Days 29-35
Secondary outcomes:
measure: 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.
timeFrame: Days 1-7
measure: Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
timeFrame: 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
measure: Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
timeFrame: 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
Other outcomes:
Locations:
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: