A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
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|ClinicalTrials.gov Identifier: NCT04439799|
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism, Male||Drug: Testosterone Cypionate 200 MG/ML Drug: Intranasal Testosterone||Phase 4|
Administration of exogenous testosterone as efficacious treatment for male hypogonadism has been part of medical practice for more than 50 years. Testosterone replacement therapy (TRT) is becoming more widely available and has seen a greater than three-fold increase in use in men 40 years and older. Current delivery systems of TRT include transdermal gels and patches, intranasal gels (currently marketed as Natesto), injection therapy, and long acting subcutaneous pellets.
Natesto is a short-acting formulation of testosterone delivered intranasally to men diagnosed with low T. This has the potential to avoid side effects related to TRT that are commonly seen with other delivery methods, namely polycythemia, acne, male-pattern hair loss, azoospermia and hyperestrogenemia.
Testosterone Cypionate injections are the most common form of TRT in the USA. Testosterone Cypionate has many reported side effects, the most common being polycythemia, gynecomastia, hair loss, acne, decreased spermatogenesis, and testicular atrophy. In a multicenter retrospective study, it has been shown that the prevalence of polycythemia in men on testosterone replacement (injections) was 11.2%. In this study, we will compare hematocrit changes caused by treatment with Testosterone Cypionate and Natesto in a parallel arm, randomized study. To date, there have been no direct head-to-haed comparisons of these formulations.
We hypothesize that the short-acting pharmacokinetics of Natesto more closely resembles the natural pulsatility of testosterone and therefore can avoid side effects traditionally seen in long-acting, exogenous testosterone formulations
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections: A Phase IV, Prospective, Randomized, Non-Blinded, Multi-Institutional Study|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||June 15, 2022|
|Estimated Study Completion Date :||June 15, 2022|
Active Comparator: Testosterone Cypionate Group
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Drug: Testosterone Cypionate 200 MG/ML
Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
Active Comparator: Natesto Group
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Drug: Intranasal Testosterone
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,
Other Name: Natesto
- Change in Hematocrit (Hct) levels. [ Time Frame: Baseline, 4 months ]Changes in serum Hct levels will be assessed in %
- Change in gonadotropin levels [ Time Frame: Baseline, 4 months ]Change in serum gonadotropin levels including Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH), both assessed in mIU/mL.
- Change in hormone levels [ Time Frame: Baseline, 4 months ]Change in serum hormone levels including Testosterone, 17 -Hydroxyprogesterone (17-OHP) and Dihydrotestosterone (DHT), all assessed in ng/dL.
- Change in PSA levels [ Time Frame: Baseline, 4 months ]Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL.
- Change in estrogen levels [ Time Frame: Baseline, 4 months ]Change in serum estrogen levels will be assessed in pg/mL.
- Change in Testicular Volume [ Time Frame: baseline, 4 months ]changes in testicular volume will be assessed in cc. An orchidometer will be the instrument of assessment during physical exam.
- Changes in IIEF score [ Time Frame: Baseline, 4 months ]The International Index of Erectile Function (IIEF)-15 is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.
- 8. Change in SF-15 Erectile Function Domain Scores [ Time Frame: Baseline, 4 months ]The Short Form (SF)-15 Questionnaire Erectile Function domain has a total score ranging from 0-25 with the higher score indicating better erectile function.
- Change in SF-15 Intercourse Satisfaction Domain Scores [ Time Frame: Baseline, 4 months ]The SF-15 Questionnaire Intercourse Satisfaction domain has a total score ranging from 0-15 with the higher score indicating better intercourse satisfaction.
- Change in SF-15 Questionnaire Scores [ Time Frame: Baseline, 4 months ]The SF-15 Questionnaire Orgasmic Function, Sexual Desire and Overall Satisfaction domains each has a total score ranging from 0-10 with the higher score indicating better outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439799
|Contact: Manuel Molina, MDemail@example.com|
|United States, Florida|
|University of Miami Miller School of Medicine||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ranjith Ramasamy, MD 305-243-4562 firstname.lastname@example.org|
|Principal Investigator: Ranjith Ramasamy, MD|
|Principal Investigator:||Ranjith Ramasamy, MD||University of Miami|