Clinical trials: Precocious Puberty
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
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
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
Precocious Puberty, Gonadotropin-dependent
(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty
The goal of this clinical trial is to evaluate the safety, tolerability, and blood levels of (Z)-endoxifen in girls with McCune-Albright Syndrome that have peripheral precocious puberty.
- Trial name
- NCT07869732
- Testing
- (Z)-endoxifen
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Atossa Therapeutics, Inc.
Central Precocious Puberty
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with…
- Trial name
- NCT06129539
- Testing
- Debio 4326
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 56 people
- Sponsor
- Debiopharm International SA
Central Precocious Puberty
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty
- Trial name
- NCT07710430
- Testing
- Leuprorelin
- Where
- South Korea
- Volunteers
- 43 people
- Sponsor
- LG Chem
Central Precocious Puberty
A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.
- Trial name
- NCT02993926
- Testing
- Enantone, GnRH agonist
- Where
- 6 sites in China
- Volunteers
- 108 people
- Sponsor
- Takeda
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.
Puberty, Precocious
Study of Lupron Depot In The Treatment of Central Precocious Puberty
The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after…
- Trial name
- NCT00660010
- Testing
- Lupron (leuprolide acetate)
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- Abbott
Central Precocious Puberty (CPP)
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a…
- Trial name
- NCT03695237
- Testing
- Leuprolide Acetate (LA)
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 45 people
- Sponsor
- AbbVie
Puberty, Precocious
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).
- Trial name
- NCT00635817
- Testing
- Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 84 people
- Sponsor
- Abbott
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
Central Precocious Puberty
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study…
- Trial name
- PUPIL (NCT05341115)
- Testing
- Leuprorelin Acetate Depot 3M
- Where
- 5 sites in China
- Volunteers
- 79 people
- Sponsor
- Takeda
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
Precocious, Leuprolide Acetate
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
- Conditions
- Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa)
- Trial name
- NCT00667446
- Testing
- Leuprolide Acetate 3 Month Depot
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 72 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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.
Central Precocious Puberty
Evaluate the Efficacy and Safety of DWJ108J
This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.
- Trial name
- NCT06025409
- Testing
- Leuprolide Acetate 11.25 MG/ML
- Where
- South Korea
- Volunteers
- 79 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Precocious Puberty
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.
- Trial name
- DECAPUB (NCT00909844)
- Testing
- Triptorelin (I.N.N.)
- Where
- 10 sites in France
- Volunteers
- 35 people
- Sponsor
- Ipsen
Early Puberty
The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1
A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female
- Trial name
- NCT04840745
- Testing
- CKD-841 A-1 3.75mg, CKD-841 A-1 1.88mg, CKD-841 D 2.92mg
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Precocious Puberty, Central
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
- Trial name
- NCT02452931
- Testing
- Leuprolide Acetate 45 mg
- Where
- 20 sites in United States, Argentina and 4 more
- Volunteers
- 64 people
- Sponsor
- Tolmar Inc.