NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

NCT00647868 | Completed Phase 1

• 1 other identifier: Nasobol 01/2008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. The serum levels obtained will be compared with those of healthy men. It is expected that intranasal administration of Nasobol will restore testosterone and DHT levels to nearly normal.

Conditions

Hypogonadism

Keywords

pharmacokinetics; testosterone; hypogonadism

Outcome Measures

Primary Outcomes (1)

• Testosterone serum concentration

  14 and 28 days after treatment

Secondary Outcomes (1)

• Difference of serum T levels in treated hypogonadal men vs. eugonadal men

  After 14 and 28 days of treatment

Study Arms (3)

Groups 1 and 2

EXPERIMENTAL

Twice daily (7:00 am and 12:00 am or 7:00 am and 10:00 pm) dosing with intranasal testosterone for 14 days

Drug: testosterone

Groups 3a and b

EXPERIMENTAL

Single daily administration of testosterone (at 7:00 am or 10:00 pm) for 14 days

Drug: testosterone

Group 4

NO INTERVENTION

24-h blood sampling in healthy eugonadal controls

Interventions

testosterone DRUG

Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application

Also known as: Nasobol

Groups 1 and 2; Groups 3a and b

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 20-60 years;
• normal thyroid function, physiologic prolactin concentration;
• normal otorhinolaryngologic examination (ENT examination);
• normal 24-h activity-rest pattern;
• written Informed Consent.

You may not qualify if:

• significant intercurrent disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus or psychiatric illness (patients with treated hyperlipidemia, arterial hypertension or treated hyper- or hypothyroidism will not be excluded provided they have been stable on their medication for at least two months);
• history of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
• sleeping disorders;
• abnormal prostate examination indicative for prostate cancer or elevated serum PSA levels (PSA \< 2.5 ng/ml for subjects \< 40 years of age and \< 4 ng/ml for subjects \>= 40 years of age);
• history of cancer, especially breast, prostate or testicular tumor; excluding skin cancer;
• history of severe or multiple allergies, severe adverse drug reaction or leucopenia. A known hypersensitivity to lignocaine/lidocaine or all surgical dressings which may be used in the study procedures;
• history of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies;
• the patient is a heavy smoker currently smoking \> 20 cigarettes per day or smoking history \>10 pack years (1 pack year is defined as 20 cigarettes per day for 1 year);
• regular drinkers of more than four (4) units of alcohol daily (1 unit = 300 ml of beer, 1 glass of wine, 1 measure of spirit) or those who may have difficulty in abstaining from alcohol during the 48 hours prior to the initial-dose administration and for the duration of the study;
• history or current evidence of abuse of alcohol or any drug substance, licit or illicit; or positive urine drug and alcohol screen for drugs of abuse and alcohol;
• treatment with other androgens (e.g. DHEA), anabolic steroids or other sex hormones within one month prior to Day 1 of the study;
• testosterone treatment in the previous 2 weeks (oral, buccal, topical, nasal) or 4 weeks (intramuscular);
• current or recent (previous 4 weeks) use of over the counter male enhancement products;
• use of nasal decongestants and nasal corticosteroids;
• shift work;

Sponsors & Collaborators

• Acerus Pharmaceuticals Corporation: lead

Study Sites (1)

Harbor - UCLA Medical Center

Torrance, California, 90509, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Christina Wang, MD

  General Clinical Research Center - Harbor UCLA Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

US (1)