Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients

Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients - Special Drug Use-Results Survey of Gonalef (MHH)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033659

Enrollment

300

Registered

2018-08-08

Start date

2006-06-20

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

Male Hypogonadotropic Hypogonadism

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Participating patients of Drug Use-Results Survey of Gonalef (MHH) 2. All patients who were administrated Gonalef up to 1 year for patient with male hypogonadotropic hypogonadism (MHH), the indication of this Drug Use-Results Survey, including idiopathic, secondary and genetic MHH.

Exclusion criteria

Exclusion criteria: Patients who do not give a full consent to this survey.

Design outcomes

Primary

Measure	Time frame
(Safety) 1. Adverse events 1-1. Frequency and severity of adverse events 1-2. The relationship between adverse events and dose, dosage form or manufacturing method (serum-free)	—

Secondary

Measure	Time frame
(Safety) 1. Changing of body weight 1-1. Descriptive statistics of observed values and change from baseline are summarized in a table or a figure. (Effectiveness) 1. Spermatogenesis 1-1. The percentage of the patients who show spermatogenesis and its 95% CI are presented. 1-2. Descriptive statistics of the time to spermatogenesis from start of concomitant therapy are presented. 1-3. Background factors that may have influence on efficacy (spermatogenesis) are analyzed by multivariate analysis. 2. Other effectiveness endpoints (Serum testosterone level, Tanner stage (pubic hair and penis), Capacity of testis) 2-1. Descriptive statistics of observed values and change from baseline are summarized 3. Pregnancy of the partner	—

Measure

Time frame

(Safety) 1. Changing of body weight 1-1. Descriptive statistics of observed values and change from baseline are summarized in a table or a figure. (Effectiveness) 1. Spermatogenesis 1-1. The percentage of the patients who show spermatogenesis and its 95% CI are presented. 1-2. Descriptive statistics of the time to spermatogenesis from start of concomitant therapy are presented. 1-3. Background factors that may have influence on efficacy (spermatogenesis) are analyzed by multivariate analysis. 2. Other effectiveness endpoints (Serum testosterone level, Tanner stage (pubic hair and penis), Capacity of testis) 2-1. Descriptive statistics of observed values and change from baseline are summarized 3. Pregnancy of the partner

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Countries

Japan

Contacts

Public ContactHiroshi Suzuka

Merck Serono Co., Ltd. PMS Planning & Strategy, Medical Department

hiroshi.suzuka@merckgroup.com03-6756-0837

Outcome results