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Subutanous testosterone therapy in hypogonadal men

Study of efficacy and patient satisfaction with subcutaneous vs intramuscular testosterone enanthate in hypogonadal male patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049024
Enrollment
22
Registered
2023-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: subcutaneous testosterone: compare subcutaneous testosterone with intramuscular testosterone. 250 mg of IM testosterone will be administred following which peak( at 10 or 14 days) an na

Sponsors

Dr Nikhil Bhagwat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult hypogonadal men =18 who are already on stable dose of Intramuscular Testosterone Enanthate therapy for more than 3 months duration

Exclusion criteria

Exclusion criteria: 1.Coexistent Liver /Renal dysfunction 2.Congestive heart failure 3.History of following within the last 6 months of screening: Myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease 4.Systemic infections 5.Positive serology for HIV, hepatitis B or hepatitis C 6.Skin conditions in injection site that could confound injection site assessments. 7.Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements 8.History or current evidence of breast or prostate cancer 9.Elevated prostate-specific antigen (PSA) for age 10.H/o psychiatric illnesses

Design outcomes

Primary

MeasureTime frame
To study the effects of subcutaneous injection Testosterone enanthate on Peak and trough Serum Testosterone concentrations when compared to Intramuscular administration of Injection Testosterone enanthate.Timepoint: at end of 4 weeks of Intramusular injection. On day 1,3 and 7 of every week following subutanous injection in month 1 , and month 3

Secondary

MeasureTime frame
To compare the effects of Subcutaneous Testosterone Injection enanthate with Intramuscular Testosterone enanthate in terms of 1. Quality of life 2. Adverse Drug Reactions Timepoint: over 1 year

Countries

India

Contacts

Public ContactAnkan Jha

Topiwala National Medical college

bhagwatnik@yahoo.co.in9820238399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026