Central Precocious Puberty. Precocious puberty
Conditions
Interventions
Intervention 1: Intervention group: Leuprorelin acetate 3.75 mg subcutaneous injection every 28 days for 6 months. Leuprorelin is a gonadotropin-releasing hormone (GnRH) analog that acts by suppressin
Sponsors
Ardabil University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
No minimum to 8 Years
Inclusion criteria
Inclusion criteria: Evidence of thelarche before 8 years of age Estradiol level greater than 20 pg/ml LH/FSH ratio greater than 1 LH increase of more than 5 units in response to GnRH Uterine length greater than 36 mm on ultrasound Bone age greater than chronological age
Exclusion criteria
Exclusion criteria: Cardiovascular diseases Hepatic and renal diseases Thyroid disorders Central precocious puberty due to brain tumors Central nervous system infections and trauma Participation in other clinical studies in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine size measured in millimeters. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Pelvic ultrasonography.;Ovarian size measured in millimeters. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Pelvic ultrasonography.;Uterine volume measured in cubic centimeters. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Pelvic ultrasonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovarian volume measured in cubic centimeters. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Pelvic ultrasonography.;Number of ovarian follicles. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Pelvic ultrasonography.;Endometrial thickness measured in millimeters. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Pelvic ultrasonography.;Body mass index calculated as weight in kilograms divided by height in meters squared. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Digital scale for weight measurement and plastic measuring tape for height measurement.;Breast size measured in centimeters. Timepoint: Baseline measurement before treatment initiation and 6 months after treatment commencement. Method of measurement: Plastic measuring tape. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArezoo Fekrat
Ardabil University of Medical Sciences
Outcome results
None listed