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An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency

An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039505
Enrollment
Unknown
Registered
2020-10-30
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-01

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

Conditions

Adult growth hormone deficiency

Interventions

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. According to the history, clinical symptoms and signs, insulin tolerance test and imaging examination, those patients who were diagnosed as adult growth hormone deficiency were those who developed adult growth hormone deficiency after 18 years old; The diagnosis of AGHD: for example, the patients after pituitary surgery (2 years after pituitary adenoma surgery, 5 years after craniopharyngioma surgery, 12 years after other pituitary tumors surgery) The peak value of plasma growth hormone in insulin tolerance test was less than 5ng / ml (insulin tolerance test may not be performed in the following cases: anterior pituitary insufficiency, pituitary hormone deficiency more than three kinds, and IGF-1 was lower than the lower limit of normal range, i.e. - 2sd); 2. Male aged 18-50 years; 3. Those who had not used growth hormone for more than one year; 4. Body mass index: 18.5 kg / m2 <= BMI <= 30 kg / m2; 5. When there is a lack of other hormones (such as glucocorticoid, thyroid hormone, sex hormone), the patients should have received the replacement therapy of other hormones, and the treatment dose is stable in the first three months; 6. The subjects are willing and able to cooperate with the scheduled visit, treatment plan, laboratory examination and other test procedures, and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart disease, including cardiac function grade III or above, severe arrhythmia, unstable angina pectoris or myocardial infarction in the past six months, etc.; 2. Patients with history of ischemic cerebrovascular disease, febrile convulsion and epilepsy; 3. Patients with carpal tunnel syndrome; 4. Patients with poor control of hypertension; 5. Patients with previous or current history of malignant tumor; 6. Patients undergoing antidepressant therapy, immunosuppressive therapy, chemotherapy, radiotherapy (or with a history of radiotherapy); 7. The objects who have used slimming drugs in the past three months; 8. Patients with severe infection; 9. Patients with disturbance of consciousness and psychosis; 10. Subjects with abnormal glucose metabolism; 11. Patients with abnormal liver and kidney function; 12. The patients whose anti HBC, HBsAg and HBeAg were positive by HBV detection; 13. Patients with allergic constitution or allergic to proteins, or allergic to experimental drugs and excipients in this study; 14. Patients who participated in clinical trials of other drugs within three months; 15. Subjects with other mental or physical defects that affect the evaluation of the test drug; 16. If the tumor marker level exceeds the upper limit of the normal range, the researcher will determine whether it is suitable for the clinical trial; 17. Other conditions considered unsuitable by the researchers for inclusion in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Semen analysis;Assessment of erectile function;

Secondary

MeasureTime frame
Quality of life assessment;Testicular size;

Countries

China

Contacts

Public ContactZhaoyun Zhang

Huashan Hospital Affiliated to Fudan University

zhaoyunzhang@fudan.edu.cn+86 15000275016

Outcome results

None listed

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