Subcutaneous vs. Intramuscular Testosterone

NCT03091348 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MHB023
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration.

Conditions

Testosterone Deficiency; Hypogonadism, Male

Outcome Measures

Primary Outcomes (2)

• Change in Levels of Serum Total Testosterone Concentration

  Blood samples measured by Beckman assays and equipment.

  "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

• Change in Levels of Serum Calculated Free T Concentration

  Blood samples measured by Beckman assays and equipment.

  "Last visit ( Visit 7)"

Secondary Outcomes (8)

• Change in Levels of Serum Estradiol

  "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

• Change in Levels of Serum LH

  "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

• Change in Levels of Serum FSH

  "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

• Change in Levels of Serum SHBG

  "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"

• Change in Level of Serum PSA

  "Last visit (Visit 7)"

Study Arms (2)

SQ - IM

EXPERIMENTAL

Subcutaneous testosterone injection followed by intramuscular testosterone injection

Drug: Testosterone

IM - SQ

EXPERIMENTAL

Intramuscular testosterone injection followed by subcutaneous testosterone injection

Drug: Testosterone

Interventions

Testosterone DRUG

Testosterone cypionate injection

Also known as: Testosterone cypionate, Testosterone injection

IM - SQ; SQ - IM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to read, write, and understand English
• Age greater than or equal to 18
• Diagnosed with testosterone deficiency
• Pre-enrollment testosterone concentration of less than 350 ng/dL
• Planning to initiate testosterone treatment at MHB
• Willing to be followed at MHB for at least one month
• Willing to provide informed consent for this study

You may not qualify if:

• Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen Receptor Modulators, unless off therapy for at least 12 weeks
• American Urological Association Prostate Symptom score of 15 or greater or significant prostatic symptoms
• History of carcinoma, tumors or induration of the prostate or the male mammary gland, including suspicion thereof
• Pre-enrollment serum PSA more than 4 ng/ml
• Serious psychiatric disease or uncontrolled medical illness, as suspected from the history or clinical examination
• Used any sex hormones or steroidal anabolic drug supplements within 28 days before pre-enrollment testosterone collection or at any time throughout the study
• Incapable of giving informed consent or complying with the protocol

Sponsors & Collaborators

• Men's Health Boston: lead

Study Sites (1)

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Eunuchism

Interventions

Testosterone; testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Hypogonadism; 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

Results Point of Contact

• Title: Abraham Morgentaler
• Organization: Men

research@menshealthboston.com

617-277-5000

Study Officials

• Abraham Morgentaler, MD

  Men's Health Boston, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: August 29, 2017
• Primary Completion: November 21, 2017
• Study Completion: January 2, 2018
• Last Updated: October 8, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-09

Locations

US (1)