Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor.

Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor. - T trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033962

Enrollment

Registered

2018-08-30

Start date

2018-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor

Interventions

teststeron replacement therapy (testosterone enanthate 250mg/4weeks, 48weeks)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: The patient who satisfies that total teststeron is low and LH is not high, and that other hormone is stable, and who don't receive testosterone or gonadotropin replacement therapy.

Exclusion criteria

Exclusion criteria: heart failure(NYHA >3degree), liver disease(AST >100IU/ml or ALT >100IU/ml), kidney disease(Cr >2.0mg/dl), prostatic cancer or PSA >4ng/dl, urinary symptom(IPSS >19points), high-risk for coronary disease (anamnesis of myocardial infarction, stroke, the past of unstable angina in recent three months), insufficient blood pressure control(sBP >160mmHg or dBP >100mmHg), polycytemia(Ht >50%), cognitive functional disorder, assignment hope. In addition, the patient who judged that the medical attendant is inappropriate is excluded.

Design outcomes

Primary

Measure	Time frame
QOL(short form 36(SF-36), Agingmales' symptoms (AMS))	—

Secondary

Measure	Time frame
metabolic parameter, other hormones	—

Countries

Japan

Contacts

Public ContactMukai Kosuke

Osaka University Graduate School of Medicine Department of Metabolic Medicine

mukai@endmet.med.osaka-u.ac.jp06-6879-3732

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026