Clinical trials: Female Adolescents
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.
Uncomplicated Urinary Tract Infections
A Study to Investigate Pivmecillinam Versus Nitrofurantoin in Female Adolescents 12 to Less Than 18 Years of Age With Uncomplicated Urinary Tract Infection
Multicenter, Randomized, Open-label, Active-controlled Study with Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12…
- Trial name
- NCT07871968
- Testing
- Pivya (Pivmecillinam 185 mg), Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Alembic Therapeutics
Papillomavirus Infections
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV)…
- Trial name
- NCT01254643
- Testing
- V503
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Sarcoma, Neuroblastoma
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
Background: Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate, which is a widely used anticancer drug, and packages it into a tiny fat bubble known as a liposome.
- Conditions
- Sarcoma, Neuroblastoma, Wilms Tumor, Leukemia
- Trial name
- NCT01222780
- Testing
- Marqibo
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Acrotech Biopharma Inc.
Infections, Papillomavirus
Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the…
- Trial name
- NCT00120848
- Testing
- HPV 16/18 VLP AS04
- Where
- 27 sites in United States, Brazil and 1 more
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Infections, Papillomavirus
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of…
- Trial name
- NCT00534638
- Testing
- Cervarix, Engerix-B
- Where
- 6 sites in Finland
- Volunteers
- 34,412 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Bladder, Overactive
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults.
- Trial name
- LION (NCT01565707)
- Testing
- Solifenacin Succinate Suspension, Urotherapy
- Where
- 46 sites in United States, Belgium and 14 more
- Volunteers
- 189 people
- Sponsor
- Astellas Pharma Europe B.V.
Cervical Cancer, Genital Warts
Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.
- Trial name
- NCT00092495
- Testing
- V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
- Volunteers
- 3,055 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Tract Infections
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
- Trial name
- SIS (NCT06597344)
- Testing
- Gepotidacin
- Where
- 22 sites in United States
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
Endometriosis
Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent
ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium.
- Trial name
- ADOmiARN (NCT05928442)
- Testing
- in vitro diagnostic medical device, Completion of a self-questionnaire
- Where
- 13 sites in Belgium, France and 1 more
- Volunteers
- 80 people
- Sponsor
- ZIWIG
Thrombotic Microangiopathies, Atypical Hemolytic Uremic Syndrome
Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome
The purpose of this study is to evaluate the platelet count change from baseline and safety of OMS721 (narsoplimab) in adults and adolescents with atypical hemolytic uremic syndrome (aHUS).
- Trial name
- aHUS (NCT03205995)
- Testing
- OMS721 (narsoplimab)
- Where
- 4 sites in United States, Lithuania and 2 more
- Volunteers
- 6 people
- Sponsor
- Omeros Corporation
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.
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.
Urinary Bladder, Overactive
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
- Trial name
- LEOPARD (NCT01655069)
- Testing
- Solifenacin succinate suspension
- Where
- 39 sites in United States, Belgium and 14 more
- Volunteers
- 148 people
- Sponsor
- Astellas Pharma Europe B.V.
Primary Immunoglobulin A Nephropathy (IgAN)
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A…
- Trial name
- NCT06994845
- Testing
- iptacopan
- Where
- 20 sites in United States, Argentina and 6 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Autosomal Recessive Polycystic Kidney (ARPKD)
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
- Trial name
- NCT04782258
- Testing
- Tolvaptan Suspension, Tolvaptan Tablets
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 20 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Atypical Hemolytic Uremic Syndrome
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUS
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).
- Trial name
- aHUS (NCT00844428)
- Testing
- eculizumab
- Where
- 13 sites in Canada, France and 5 more
- Volunteers
- 5 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Herpes Simplex
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA.
- Trial name
- NCT00224471
- Testing
- GSK208141 vaccine
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 671 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline