Effects of Medications in Patients With Hypogonadism

Gulhane School of Medicine

Status and phase: Completed; Phase 4

Conditions: Idiopathic Hypogonadotropic Hypogonadism

Treatments: Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU); Drug: Testosterone enanthate (Sustanon 250 mg); Drug: Testosteron gel (Testojel 50 mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT01601327

01052012

Details and patient eligibility

About

The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).

Enrollment: 119 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: hypogonadotropic hypogonadism

• decreased serum testosterone concentration below the normal range (serum T < 300ng/dL),
• FSH and LH levels within or below the normal range,
• absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH,
• normal smell test and normal karyotypes

Exclusion Criteria:

• previous androgen treatment,
• history of smoking,
• presence of bilateral anorchia,
• intellectual deficiency,
• diabetes mellitus,
• arterial hypertension or dyslipoproteinemia,
• medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

Participants with iron, vitamin B12 or folate deficiency were also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

hypogonadism, treatment

Other group

Description:

77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin

Treatment:

Drug: Testosteron gel (Testojel 50 mg)

Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)

Drug: Testosterone enanthate (Sustanon 250 mg)

Control group

No Intervention group

Description:

42 healthy controls

Treatment:

Drug: Testosterone enanthate (Sustanon 250 mg)