Phase 2 Completed N=20 Treatment

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

Hypogonadal Males

Source: ClinicalTrials.gov NCT01464879 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcomePrimary: 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. — 16.7; 50.0; 77.8 percentage of subjects

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

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	16.7; 50.0; 77.8	—
SECONDARY 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.	50	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)	5768; 7686; 10295; 688; 974; 1223	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)	3.77; 3.77; 3.77; 3.75; 3.78; 3.86	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)	396; 641; 1024; 37.6; 57.7; 78.9	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Cavg	325; 47.6	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)	173; 213; 250; 21.1; 29.9; 37.3	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)	7.78; 10.81; 4.76; 9.83; 11.0; 9.79	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ	7809; 1143	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Tmax	1.86; 1.86	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Cmax	517; 69.1	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Cmin	234; 35.4	—
SECONDARY Pharmacokinetics of Total Testosterone and DHT Measuring Tmin	8.84; 11.8	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01464879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.