NCT04439799

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2023

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

May 25, 2020

Results QC Date

November 21, 2023

Last Update Submit

November 21, 2023

Conditions

Hypogonadism, Male

Keywords

Low T

Outcome Measures

Primary Outcomes (1)

  • Change in Hematocrit (Hct) Levels.

    Changes in serum Hematocrit levels will be assessed in percentage

    Baseline to 4 months

Secondary Outcomes (4)

  • Change in Hormone Levels

    Baseline to 4 months

  • Change in PSA Levels

    Baseline to 4 months

  • Change in Estradiol Levels

    Baseline to 4 months

  • Changes in IIEF-6 Score

    Baseline to 4 months

Study Arms (2)

Testosterone Cypionate Group

ACTIVE COMPARATOR

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

Drug: Testosterone Cypionate 200 Mg/ML

Natesto Group

ACTIVE COMPARATOR

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

Drug: Intranasal Testosterone

Interventions

Testosterone Cypionate 200 Mg/MLDRUG

Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.

Testosterone Cypionate Group
Intranasal TestosteroneDRUG

Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,

Also known as: Natesto
Natesto Group

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily sign and date the study consent form(s), which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
  • Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
  • Serum total testosterone \< 300 ng/dL on 2 measurements
  • Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 months following androgen treatment.
  • Men deemed to be candidates for TRT based on the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

You may not qualify if:

  • History of significant sensitivity or allergy to androgens, or product excipients.
  • Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.
  • Abnormal prostate digital rectal examination (DRE) with palpable nodule(s)
  • Body mass index (BMI) ≥ 40 kg/m2.
  • Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
  • Baseline hemoglobin \> 16 g/dL or Hematocrit (HCT) 48%
  • Prostate Specific Antigen (PSA) \> 4 ng/mL
  • History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
  • History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
  • History of stroke or myocardial infarction within the past 5 years.
  • History of, or current or suspected, prostate or breast cancer.
  • History of diagnosed, severe, untreated, obstructive sleep apnea.
  • History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
  • Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
  • Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (12)

  • Corona G, Rastrelli G, Maggi M. Diagnosis and treatment of late-onset hypogonadism: systematic review and meta-analysis of TRT outcomes. Best Pract Res Clin Endocrinol Metab. 2013 Aug;27(4):557-79. doi: 10.1016/j.beem.2013.05.002. Epub 2013 Jul 5.

    PMID: 24054931BACKGROUND

  • Haring R, Volzke H, Steveling A, Krebs A, Felix SB, Schofl C, Dorr M, Nauck M, Wallaschofski H. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20-79. Eur Heart J. 2010 Jun;31(12):1494-501. doi: 10.1093/eurheartj/ehq009. Epub 2010 Feb 17.

    PMID: 20164245BACKGROUND

  • Walker WH. Testosterone signaling and the regulation of spermatogenesis. Spermatogenesis. 2011 Apr;1(2):116-120. doi: 10.4161/spmg.1.2.16956.

    PMID: 22319659BACKGROUND

  • Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65. doi: 10.1210/jcem.81.12.8954042.

    PMID: 8954042BACKGROUND

  • Finkelstein JS, Klibanski A, Neer RM, Greenspan SL, Rosenthal DI, Crowley WF Jr. Osteoporosis in men with idiopathic hypogonadotropic hypogonadism. Ann Intern Med. 1987 Mar;106(3):354-61. doi: 10.7326/0003-4819-106-3-.

    PMID: 3544993BACKGROUND

  • Jockenhovel F, Vogel E, Reinhardt W, Reinwein D. Effects of various modes of androgen substitution therapy on erythropoiesis. Eur J Med Res. 1997 Jul 28;2(7):293-8.

    PMID: 9233903BACKGROUND

  • Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x.

    PMID: 7514512BACKGROUND

  • Davidson JM, Camargo CA, Smith ER. Effects of androgen on sexual behavior in hypogonadal men. J Clin Endocrinol Metab. 1979 Jun;48(6):955-8. doi: 10.1210/jcem-48-6-955.

    PMID: 447801BACKGROUND

  • Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731.

    PMID: 10946864BACKGROUND

  • Baillargeon J, Urban RJ, Ottenbacher KJ, Pierson KS, Goodwin JS. Trends in androgen prescribing in the United States, 2001 to 2011. JAMA Intern Med. 2013 Aug 12;173(15):1465-6. doi: 10.1001/jamainternmed.2013.6895. No abstract available.

    PMID: 23939517BACKGROUND

  • Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014.

    PMID: 24470750BACKGROUND

  • Rivero MJ, Ory J, Diaz P, Thirumavalavan N, Han S, Reis IM, Ramasamy R. Comparison of Hematocrit Change in Testosterone-deficient Men Treated With Intranasal Testosterone Gel vs Intramuscular Testosterone Cypionate: A Randomized Clinical Trial. J Urol. 2023 Jul;210(1):162-170. doi: 10.1097/JU.0000000000003487. Epub 2023 May 1.

    PMID: 37126399DERIVED

MeSH Terms

Conditions

Eunuchism

Interventions

testosterone 17 beta-cypionateNatesto

Condition Hierarchy (Ancestors)

HypogonadismGonadal DisordersEndocrine System Diseases

Results Point of Contact

Title
Ranjith Ramasamy, MD
Organization
University of Miami, Miller School of Medicine - Desai Sethi Urology Institute
Ramasamy@miami.edu
305-243-6596

Study Officials

  • Ranjith Ramasamy, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Male Fertility and Andrology, University of Miami

Study Record Dates

First Submitted

May 25, 2020

First Posted

June 19, 2020

Study Start

August 7, 2020

Primary Completion

February 9, 2023

Study Completion

February 9, 2023

Last Updated

December 13, 2023

Results First Posted

December 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)