Natesto vs Testosterone Injections for Low Testosterone

Overseen by Ranjith Ramasamy, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate changes in vascular parameters and the prevalence of side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to participant with clinical hypogonadism.

Research Team

Ranjith Ramasamy, MD

Principal Investigator

University of Miami

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with a condition that affects the function of your reproductive glands.

You have not started taking or have stopped taking hormone replacement therapy for at least 4 months.

Consent forms have been approved by an Institutional Review Board

Exclusion Criteria

You have had a strong allergic reaction to androgens or any ingredients in the product.

Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.

Your doctor has felt an unusual lump during a prostate exam.

Treatment Details

Interventions

• Intranasal Testosterone (Androgen Replacement Therapy)
• Testosterone Cypionate 200 MG/ML (Androgen Replacement Therapy)

Participant Groups

Group I: Testosterone Cypionate Group Active Control 1 Intervention

Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months

Group II: Natesto Group Active Control 1 Intervention

Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Acerus Pharmaceuticals Corporation

Industry Sponsor

Trials

14

Recruited

6,400+