Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotrop… (NCT03687606) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)
China210 participantsStarted 2018-10-18
Plain-language summary
This study will evaluate the efficacy and safety of long term use of hCG alone or hCG plus hMG in the treatment of male patients with isolated hypogonadotropic hypogonadism (IHH). One third of the participants will receive hCG treatment alone and the other third of the participants will receive hCG treatment alone for six months, then the hMG will be added. And the last third of the participants will receive hCG and hMG treatment since the beginning of the treatment.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Age ≥ 18, ≤ 45 years old;
✓. Adolescent dysplasia or loss of puberty: Genital Tanner score ﹤ 5, pubic hair Tanner score ﹤ 5;
✓. Serum FSH and LH levels are low or in normal low value, testosterone was lower than normal range (1.75ng / ml, the lower limit of the normal blood testosterone reference range of Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology);
✓. With or without olfactory loss/reduction;
✓. Other pituitary hormone levels are normal;
✓. Head MRI examination is normal;
✓. Fertility is desired currently or will be desired in the future;
✓. Understand and sign the informed consent form.
Exclusion criteria
✕. Primary hypogonadism;
✕. Acquired hypogonadotrophic hypogonadism;
✕. A history of treatment with pulsed GnRH, hCG and FSH related hormones;
✕. Receive testosterone replacement therapy for more than 6 months;