Phase 2 N=20 Treatment

Efficacy, Pharmacokinetics and Safety of Testosterone

Testicular Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT01370369 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL. — 73.7; 77.7; 75.0; 20.0 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Testosterone gel (FE 99903) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Ferring Pharmaceuticals
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.	73.7; 77.7; 75.0; 20.0; 40.0; 55.0	—
SECONDARY Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.	519; 451; 926	—
SECONDARY Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.	24.0; 9.0; 11.0	—
SECONDARY Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.	9472; 8918; 13368	—
SECONDARY Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	586; 907; 1258	—
SECONDARY Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	6.0; 4.0; 6.0	—
SECONDARY Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	9229; 12148; 17625	—
SECONDARY Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	134; 229; 382	—
SECONDARY Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	6.0; 7.0; 6.0	—
SECONDARY Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	1765; 2655; 4663	—
SECONDARY Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	64.4; 93.3; 120	—
SECONDARY Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	6.0; 4.0; 6.0	—
SECONDARY Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.	1063; 1458; 1974	—
SECONDARY Frequency of Adverse Events (AEs)	1; 2; 2	—

Summary

This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.

Eligibility Criteria

Inclusion Criteria

Ages 18-65
History of hypogonadism
In good health based on medical history, physical examination and clinical laboratory tests
Screening morning serum testosterone ≤ 297 ng/dL
One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
Body mass index (BMI) between 18 and 31

Exclusion Criteria

Prostate cancer
Palpable prostatic mass(es)
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, finasteride, ketoconazole)
Clinically significant anemia or renal dysfunction
Hyperparathyroidism or uncontrolled diabetes
Serum PSA Levels; ≥ 4ng/mL
History of cardiovascular disease
Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01370369). 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.