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A real world study on 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 on the efficacy and safety of the combination therapy of GnRHa and rhGH in the treatment of central precocious puberty or rapid progressive adolescent girls

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016768
Enrollment
Unknown
Registered
2018-06-22
Start date
2018-06-25
Completion date
Unknown
Last updated
2018-06-25

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

Conditions

Central precocious puberty or rapid progressive adolescence

Interventions

Case series:GnRHa combined with rhGH

Sponsors

The Children's Hospital, Zhe Jiang University School of Medcine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of iCPP girl: before the age of 8 years, secondary sexual symptoms appeared, > 6 years old, bone age was no more than 12.5 years old, and bone age is at least 1 year greater than the actual age; GnRH stimulation test showed adolescent reaction. Gonadal enlargement: the ovary volume of > 1ml was observed in the girl by B-ultrasound diagnosis, and multiple follicles of > 4mm in diameter were observed; 2. Or, a diagnosis of fast progress in adolescent girls: 3 months ? bone age/? age > 2; Secondary sexual characteristics appear after the age of 8, with rapid sexual development and a relatively short time from one developmental stage to the next (<6 months); 3. Patients who have not started treatment with GnRHa or rhGH; 4. Children who agree to receive GnRHa and/or rhGH treatment at their own expense and can receive timely follow-up test, baseline and treatment information are entered into the China growth and development research database (CGSD); 5. subjects and my guardian voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with liver and kidney dysfunction (upper limit of ALT > 2 times normal value, upper limit of Cr > 2 times normal value); 2. Hepatitis B virus detection anti-HBc, HBsAg and HBeAg are all positive; 3. Those who are known to be highly allergic or allergic to the drugs tested in this study; 4. Patients with severe cardiopulmonary, blood system, malignant tumors and other diseases or systemic infections, with low immune function; 5. Proved to have other growth and development defects such as Turner syndrome, constitutional delay puberty, Laron syndrome, lack of growth hormone receptor, growth lags behind the girl did not rule out chromosome abnormality; 6. Participants who have participated in other growth and development-related drug clinical trials within 3 months; 7. Patients whose doctor think they are not suitable for this study.

Design outcomes

Primary

MeasureTime frame
predicted changes in adult height (PAH);Actual height change;

Secondary

MeasureTime frame
The annual growth rate (cm/ year);HtSDSBA;AHSDS;

Countries

China

Contacts

Public ContactJunfen Fu

The Children's Hospital, Zhe Jiang University School of Medcine

fjf68@qq.com+86 13777457849

Outcome results

None listed

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