Clinical trials: Early Puberty
Puberty Changes
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
1. Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type.
- Trial name
- NCT06820931
- Testing
- Xuandi Ziyin Mixture
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Children's Hospital of Fudan University
McCune-Albright Syndrome
Arimidex in McCune Albright Syndrome
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
- Trial name
- NCT00055302
- Testing
- Arimidex 1 mg
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Puberty, Precocious, McCune-Albright Syndrome
Faslodex in McCune-Albright Syndrome
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with…
- Trial name
- FMAS (NCT00278915)
- Testing
- Fulvestrant
- Where
- 16 sites in United States, France and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Precocious Puberty, Central
Basal LH Threshold for the Diagnosis of Central Precocious Puberty
This retrospective monocentric observational study aims to evaluate whether basal luteinizing hormone (LH) levels can reliably diagnose central precocious puberty and reduce the need for LHRH stimulation testing.
- Trial name
- CPP-LH (NCT07864116)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Polycystic Ovary Syndrome, Hyperandrogenism
Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low.
- Conditions
- Polycystic Ovary Syndrome, Hyperandrogenism, Normal Puberty
- Trial name
- NCT01428089
- Testing
- Progesterone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Puberty, Precocious
Pediatrics Testotoxicosis Study [Bicalutamide Anastrozole Treatment for Testotoxicosis]
The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys.
- Trial name
- BATT (NCT00094328)
- Testing
- Bicalutamide, Anastrozole
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Precocious Puberty, Central, Delayed Puberty
INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty
This is an observational study in children up to 16 years old who are suspected of having central precocious puberty or delayed puberty.
- Trial name
- INSL3GNRH (NCT07859787)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Precocious Puberty
Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It severely threatens physical and mental health of children. It's urgent to explore effective ways to control the disease.
- Trial name
- NCT02650141
- Testing
- ziyinxiehuo Granules, zishenqinggan Granules
- Where
- China
- Volunteers
- 143 people
- Sponsor
- Children's Hospital of Fudan University
Central Precocious Puberty
Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
The purpose of this research was to confirm the effectiveness and safety of the study drug, Triptorelin pamoate 15mg 3-month formulation, in a Chinese population of Central Precocious Puberty (CPP) children.
- Trial name
- NCT04736602
- Testing
- Triptorelin pamoate 15mg
- Where
- 7 sites in China
- Volunteers
- 32 people
- Sponsor
- Ipsen
Pediatric Obesity, Puberty, Precocious
The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
In this study, 6-10 years old obese girls will be recruited to test the preventive effect of decaffeinated green tea polyphenols on the risk of precocious puberty by the random, placebo-control and single blind design.
- Trial name
- NCT03628937
- Testing
- Decaffeinated Green Tea Polyphenol
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Precocious Puberty, Central, Executive Dysfunction
Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)
This study is part of the European Hypiend project, which aims to explore the effects of co-exposure to endocrine-disrupting chemicals (EDCs) on the function and epigenetic programming of the hypothalamic-pituitary-adrenal (HPA)…
- Trial name
- Hypiend-PPC (NCT07411001)
- Testing
- Multi-Component Behavioral intervention, Information
- Where
- Belgium
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Sciensano
Central Precocious Puberty
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v.
- Trial name
- NCT05029622
- Testing
- Triptorelin Pamoate
- Where
- 14 sites in China
- Volunteers
- 66 people
- Sponsor
- Ipsen
CPP
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP.
- Trial name
- NEST (NCT06926933)
- Testing
- Eligard® 45 mg
- Where
- 9 sites in South Korea
- Volunteers
- 50 people
- Sponsor
- HanAll BioPharma Co., Ltd.
Osteoporosis, Osteopenia
Encouraging Calcium Absorption and Bone Formation During Early Puberty
Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life.
- Trial name
- NCT00022867
- Testing
- Nondigestible oligosaccharide (NDO)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
PCOS (Polycystic Ovary Syndrome), Puberty
ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence
This study explores how a physical activity program can affect hormone health and diabetes risk in girls ages 8-12 who may be at higher risk.
- Conditions
- PCOS (Polycystic Ovary Syndrome), Puberty, Insulin Resistance, Physical Activity
- Trial name
- NCT07102797
- Testing
- ActiveGirls Physical Activity Program (Full), ActiveGirls Physical Activity Program (Delayed Lower Intensity)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Central Precocious Puberty (CPP), Puberty Disorders
Spexin and Phoenixin-20 in Girls With Central Precocious Puberty
Central precocious puberty (CPP) is characterized by the early activation of the hypothalamic-pituitary-gonadal axis in girls and may be difficult to distinguish from benign variants such as premature thelarche.
- Conditions
- Central Precocious Puberty (CPP), Puberty Disorders, Puberty, Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
- Trial name
- SPX-PNX-CPP-20 (NCT07359092)
- Where
- Turkey (Türkiye)
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Kayseri City Hospital
Precocious Puberty, Treatment
A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.
- Conditions
- Precocious Puberty, Treatment, Alternative Medicine, Acupuncture
- Trial name
- NCT06510764
- Testing
- intradermal needles, Ziyinxiehuo Granules of traditional Chinese Medicine
- Where
- 2 sites in China
- Volunteers
- 170 people
- Sponsor
- Children's Hospital of Fudan University
Puberty; Precocious, Central
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
- Trial name
- NCT05493709
- Testing
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
- Where
- 41 sites in United States, China and 2 more
- Volunteers
- 94 people
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Precocious Puberty
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
- Trial name
- NCT07141615
- Testing
- Qingwei Huazhuo Decoction: Mulberry leaf powder, lotus leaf powder, malt powder, hawthorn powder, Poria cocos powder, gardenia powder, dried tangerine peel powder, licorice powder, momordica grosvenor, diet and exercise education
- Where
- China
- Volunteers
- 94 people
- Sponsor
- Children's Hospital of Fudan University
Central Precocious Puberty
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty.
- Trial name
- NCT01467882
- Testing
- Triptorelin
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 44 people
- Sponsor
- Debiopharm International SA