PAUSE

Prolonged post-androgen abuse hypogonadism: a prospective prognostic study - Prolonged post-androgen abuse hypogonadism

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58381

Enrollment

Registered

2025-07-17

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-03-16

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

Conditions

Prolonged post-androgen abuse hypogonadism (PPAAH), hypogonadism, testosterone deficiency Testosterone deficiency

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Male participants aged 18 years or olderA history of total androgen use for at least 6 months with a cumulative weekly androgen dosage of = 150 mg/weekDocumented hypogonadism at least 3 months after cessation of androgen use, defined as:A serum (calculated) free testosteron = 225 pmol/L, andAt least one symptom suggestive of hypogonadism: decreased libido, erectile dysfunction, reduced energy, or depressed mood

Exclusion criteria

Exclusion criteria: History of hypogonadism due to causes other than androgen useUse of substances that effect endogenous testosterone production, such as opioids, glucocorticoids, or anti-androgensHistory of pituitary and/or hypothalamic disease or tumorsHistory of testicular, breast, or prostate cancerPrior treatment with chemotherapyCurrent or imminent participation in an anti-doping programRefusal to provide a urine sample for doping analysis

Design outcomes

Primary

Measure	Time frame
Time (in days since discontinuation of androgen use) to recovery of serum free testosterone =225 pmol/L.	—

Secondary

Measure	Time frame
Incidence of abnormal pituitary or testicular responses. An abnormal pituitary response is defined as a stimulated luteinizing hormone (LH) concentration < 7.4 IU/L following administration of a 100 µg GnRH bolus, or an absolute LH increase < 3.3 IU/L. An abnormal testicular response is defined as an absolute increase in total testosterone < 7.5 nmol/L following injection of 5,000 IU human chorionic gonadotropin (hCG).Frequency of positive urine doping tests at baseline and during follow-up.Incidence and nature of alternative diagnoses identified during the study.Incidence of persistent hypogonadism at least six months after cessation of androgen use, in the absence of an alternative diagnosis.Changes in serum total and free testosterone levels during follow-up in relation to time since cessation of androgen use.Changes in quality of life, mood, and sexual function, assessed using the Beck Depression Inventory (BDI), WHO-5 Well-Being Index, WHO Quality of Life Scale (WHOQOL-BREF), and the International Index of Erectile Function (IIEF), in relation to time since cessation of androgen use.Changes in testicular volume during follow-up in relation to time since cessation of androgen use.	—

Measure

Time frame

Incidence of abnormal pituitary or testicular responses. An abnormal pituitary response is defined as a stimulated luteinizing hormone (LH) concentration < 7.4 IU/L following administration of a 100 µg GnRH bolus, or an absolute LH increase < 3.3 IU/L. An abnormal testicular response is defined as an absolute increase in total testosterone < 7.5 nmol/L following injection of 5,000 IU human chorionic gonadotropin (hCG).Frequency of positive urine doping tests at baseline and during follow-up.Incidence and nature of alternative diagnoses identified during the study.Incidence of persistent hypogonadism at least six months after cessation of androgen use, in the absence of an alternative diagnosis.Changes in serum total and free testosterone levels during follow-up in relation to time since cessation of androgen use.Changes in quality of life, mood, and sexual function, assessed using the Beck Depression Inventory (BDI), WHO-5 Well-Being Index, WHO Quality of Life Scale (WHOQOL-BREF), and the International Index of Erectile Function (IIEF), in relation to time since cessation of androgen use.Changes in testicular volume during follow-up in relation to time since cessation of androgen use.

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Countries

Netherlands

Contacts

Public ContactJ Os

Spaarne Gasthuis

pausestudie@spaarnegasthuis.nlVolgt nog

Outcome results