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Comparison of the the efficacynand safety assessment of variopeptyl 11.25 mg and dipherelin 11.25 mg on girls with idiopathic central precocious puberty

Comparison of the the efficacy and safety assessment of variopeptyl 11.25 mg and dipherelin 11.25 mg on girls with idiopathic central precocious puberty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250429065526N1
Enrollment
48
Registered
2025-06-10
Start date
2023-07-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

idiopathic central precocious puberty.

Interventions

Intervention group: Diferelin and Variopeptyle group :All girls with idiopathic central precocious puberty (ICPP) are included in the study. At the beginning of the study, their clinical and paraclini

Sponsors

Varianpharmed company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
6 Years to 9 Years

Inclusion criteria

Inclusion criteria: Girls who started menstruating before the age of 9 Patients with a diagnosis of precocious puberty who have been previously treated with another GnRH analog compound and who have now stopped showing clinical signs of puberty. Advanced bone age by one year beyond chronological age Signed informed consent form No heart disease with a normal EKG

Exclusion criteria

Exclusion criteria: Sensitivity to drugs, especially GnRH agonists Central precocious puberty with a specific cause such as tumor, irradiation, etc. Those receiving growth hormone, thyroid drugs, and other drugs involved in the growth and maturation process. Those suspected of having malignant tumors Non-gonadotropin-dependent precocious puberty Any chronic diseases that interfere with growth, such as chronic steroid use, renal failure, and moderate to severe scoliosis.

Design outcomes

Primary

MeasureTime frame
Sex hormones. Timepoint: befor study and month 3 and 6 and 9. Method of measurement: laboratory test.

Secondary

MeasureTime frame
Breast and uterine and ovarian sonography. Timepoint: befor study and months 3 and 6 and 9. Method of measurement: ultrasound.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShervin Fatehi ghahfarokhi

Iran University of Medical Sciences

Fatehi65.shervin@gmail.com+98 21 7719 5346

Outcome results

None listed

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