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A real world study for the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girls

A real world study for the efficacy and safety of the combination therapy of GnRHa and recombinant human growth hormone in the treatment of central precocious puberty or rapid progressive adolescent girls.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017120
Enrollment
Unknown
Registered
2018-07-12
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

precocious puberty

Interventions

Case series:rhGH therapy

Sponsors

The Children's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Girls are diagnosed as CPP: secondary sex characteristic appears before age 8, chronological age (CA) > 6 years, Bone age (BA) = 11.5 years, BA > CA for 1 year; GnRH challenge test presents puberty response, gonad enlargement; Ovarian volume in girls under B-ultrasound > 1ml, and multiple follicles with diameters > 4mm can be seen; 2. Girls diagnosed as fast progressive puberty: secondary sex characteristic appears before age 8 years, rapid sexual development, the time from one developmental stage to the next stage is shorter (<6 months); 3. Patients who have not started treatment with GnRHa or rhGH; 4. Agree to accept GnRHa and or rhGH treatment at their own expense (at their own expense); 5. Doctors evaluated children without contraindications to rhGH; 6. Patients or their guardians are able to understand, and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Liver and renal insufficiency (ALT> 2 times the upper limit of normal, Cr> 2 times the upper limit of normal); 2. Hepatitis B virus tests positive for anti-HBc, HBsAg, and HbeAg; 3. Patients known to be highly allergic or allergic to the test drug; 4. Patients with severe cardiopulmonary, hematological and malignant tumors diseases or general infection, immune deficiency; 5. Other types of identified abnormal growth and development: such as Turner syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome; 6. Patients diagnosed with diabetes; 7. Patients who participated in clinical trials of other growth and development-related drugs within 3 months; 8. Researchers believe that patients are not suitable for inclusion in this study; 9. Patients or their guardians do not agree to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
PAH;CV;HtSDSBA;Blood routine;Urine routine;Blood biochemistry;HbA1c;IGF-1;IGFBP-3;Thyroid function;Glandular function;Adrenal function;

Countries

China

Contacts

Public ContactJunfen Fu

The Children's Hospital, Zhejiang University School of Medicine

fjf68@qq.com+86 13777457849

Outcome results

None listed

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