Clinical trials: Female Adolescents
Herpes Simplex
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).
- Trial name
- NCT00224484
- Testing
- GSK208141, Havrix (investigational formulation)
- Where
- 151 sites in United States, Australia and 16 more
- Volunteers
- 5,960 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hyperkalemia
Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
The purpose of this study is to evaluate the change in serum potassium levels from start of treatment to Day 14, when patiromer is administered at different doses, once daily, in children 2 - < 18 years of age with chronic kidney…
- Trial name
- EMERALD (NCT03087058)
- Testing
- Patiromer
- Where
- 30 sites in United States, Bulgaria and 5 more
- Volunteers
- 23 people
- Sponsor
- Vifor Pharma, Inc.
Infections, Papillomavirus
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts.
- Trial name
- NCT01953822
- Testing
- Data collection
- Volunteers
- 1,053 people
- Sponsor
- GlaxoSmithKline
Morning Sickness
The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
The primary objective of this study is to compare the efficacy of Bonjesta for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo.
- Trial name
- NCT05289557
- Testing
- Bonjesta
- Where
- 10 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Duchesnay Inc.
Infections, Papillomavirus
Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18)…
- Trial name
- NCT00492544
- Testing
- Cervarix™ (HPV-16/18 L1 VLP AS04)
- Where
- 5 sites in Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute…
- Trial name
- NCT04187144
- Testing
- Gepotidacin, Nitrofurantoin
- Where
- 113 sites in United States, Australia and 4 more
- Volunteers
- 1,606 people
- Sponsor
- GlaxoSmithKline
Menorrhagia
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy…
- Trial name
- PREA (NCT01190150)
- Testing
- tranexamic acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring Pharmaceuticals
Bacterial Vaginosis
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
- Trial name
- NCT02452866
- Testing
- SYM-1219
- Where
- 40 sites in United States
- Volunteers
- 325 people
- Sponsor
- Symbiomix Therapeutics
Chronic Kidney Disease
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD.
- Trial name
- NCT07107945
- Testing
- Empagliflozin
- Where
- 93 sites in United States, Argentina and 16 more
- Volunteers
- 135 people
- Sponsor
- Boehringer Ingelheim
Urinary Bladder Neurogenic
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
The primary objective is to investigate the pharmacokinetics (PK) of 2 doses of alfuzosin (given as a solution or tablets depending on age) in children and adolescents 2 to 16 years of age with elevated detrusor Leak Point…
- Trial name
- ALFACHIP (NCT00629720)
- Testing
- alfuzosin (SL770499)
- Where
- 2 sites in United States, Serbia
- Volunteers
- 29 people
- Sponsor
- Sanofi
Schizophrenia, Paranoid, Schizophrenia, Disorganized
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in…
- Conditions
- Schizophrenia, Paranoid, Schizophrenia, Disorganized, Schizophrenia, Undifferentiated
- Trial name
- NCT01190267
- Testing
- asenapine
- Volunteers
- 204 people
- Sponsor
- Organon and Co
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).
- Trial name
- VOCAL (NCT05288855)
- Testing
- Voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 9 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
IgA Nephropathy
Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)
This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric…
- Trial name
- NCT07770815
- Testing
- Sibeprenlimab, Standard of care
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Contraception
Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women
The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up…
- Trial name
- NCT01107106
- Testing
- ellaOne® (ulipristal acetate)
- Where
- 6 sites in United States, Sweden and 1 more
- Volunteers
- 579 people, healthy volunteers welcome
- Sponsor
- HRA Pharma
Cervical Cancer
Immunogenicity and Safety Study of NBP615 in Healthy Female
This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years.
- Trial name
- NCT04453241
- Testing
- NBP615, Gardasil
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
Endometriosis
Visanne Study to Assess Safety in Adolescents
A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.
- Trial name
- VISADO (NCT01283724)
- Testing
- Dienogest (Visanne, BAY86-5258)
- Where
- 36 sites in Austria, Czechia and 4 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Morning Sickness
A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo.
- Trial name
- PED-301 (NCT02045901)
- Testing
- Diclegis
- Where
- 8 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Duchesnay Inc.
Contraception
LCS12 Adolescent Study
The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age.
- Trial name
- NCT01434160
- Testing
- Skyla (Levonorgestrel, BAY86-5028)
- Where
- 41 sites in Austria, Belgium and 6 more
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Bayer
Human Papillomavirus (HPV) Infection, HPV (Human Papillomavirus)-Associated Carcinoma
Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) for Age/Immunization Schedule Bridging
This vaccine was jointly developed by Chengdu Institute of Biological Products Co., Ltd. and National Vaccine and Serum Institute, China, is co-sponsoring this clinical trial.
- Trial name
- NCT06632912
- Testing
- 2 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha), 3 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)
- Where
- 3 sites in China
- Volunteers
- 1,800 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
Asthma
Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal…
- Trial name
- ALIZE (NCT02814643)
- Testing
- Benralizumab, Seasonal influenza virus vaccine
- Where
- 24 sites in United States
- Volunteers
- 103 people
- Sponsor
- AstraZeneca