Replacement of male mini puberty in neonates and children with micropenis and/or cryptorchidism due to hypogonadotropic hypogonadism

Treatment of neonatal micropenis and bilateral cryptorchidism due to hypogonadotropic hypogonadism (HH) with 3-month daily subcutaneous injections of the commercially available recombinant FSH plus recombinant LH preparation (Pergoveris®)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13007297

Enrollment

Registered

2018-02-12

Start date

2009-06-01

Completion date

Unknown

Last updated

2019-07-01

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

Conditions

Hypogonadotropic hypogonadism in neonates and infants Nutritional, Metabolic, Endocrine Hypopituitarism

Interventions

Neonates or infants all with micropenis and/or bilateral cryptorchidism with absence of neonatal male mini-puberty will be treated for 3 months with daily subcutaneous injections of Pergoveris® (recom

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male neonates and infants with micropenis and/or cryptorchidism with hypogonadotropic hypogonadism

Exclusion criteria

Exclusion criteria: Gonadal dysgenesis, partial androgen resistance, 5-a reductase deficiency

Design outcomes

Primary

Measure	Time frame
Measured at baseline and 1 – 2 – 3 months after initiation of therapy: 1. Stretched penile length measured with a ruler 2. Testicular volume measured with a Prader Orchidometer 3. Ultrasound measurements of the testes recorded by an experienced Pediatric Radiologist	—

Secondary

Measure	Time frame
Height velocity and body measurements recorded and analysed by Growth Analyser ver 3.1 at baseline and 1 – 2 – 3 months after initiation of therapy	—

Countries

Greece

Outcome results

None listed

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