In short
Clinical trials involving SODIUM HYDROXIDE are listed here as part of study medicines used in specific research settings. These trials look at safety, body changes, and other effects in target groups such as women with Turner syndrome and people on hemodialysis.
Key points
- Clinical trials involving SODIUM HYDROXIDE in the provided data are part of two different interventional studies. One Phase 2 trial looks at women with Turner syndrome and measures body composition, including bone, fat, muscle, waist size, and weight. One Phase 3 trial studies chronic hemodialysis patients and measures muscle protein synthesis and hemodynamic effects. The trial data show that SODIUM HYDROXIDE is used as part of a transdermal treatment or combination product, not as a stand-alone study topic. Both trials are authorised and focus on specific patient groups and measurable outcomes.
Clinical trials overview
The provided data include two interventional studies, which means researchers give a treatment and then measure the results.
Both studies are authorised, and both include SODIUM HYDROXIDE as part of the study intervention.
One study is in Phase 2 and the other is in Phase 3, so the research is already testing effects in people rather than only in early lab work.
Turner syndrome study
The first trial is titled Testosterone Replacement Therapy in Women with Turner Syndrome and includes women with Turner syndrome.
This is a Phase 2 study with an enrollment of 50 participants.
The brief summary says the study aims to evaluate the endocrine, physiological, cardiovascular, neurocognitive, and genomic effects of transdermal TRT as a supplement to ERT in women with TS.
In simple words, the study is checking how this treatment may affect hormones, body function, heart and blood vessel health, thinking skills, and genes in this patient group.
The intervention list includes SODIUM HYDROXIDE together with other ingredients in a transdermal product, which means it is applied through the skin.
Hemodialysis study
The second trial is titled LOTUS and includes patients with muscle protein turnover issues who are on hemodialysis.
This is a Phase 3 study with an enrollment of 20 participants.
The brief summary says the study is designed to look at the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to characterize the hemodynamic effects of IDPN.
The primary outcome is the difference in myofibrillar fractional synthetic rate during one week of treatment with IDPN versus control.
This means the researchers want to see whether treatment changes the speed at which muscle protein is made, compared with a control group.
In this trial data, SODIUM HYDROXIDE appears within a combination intervention used in the study setting.
Outcomes and measures
In the Turner syndrome study, the main outcome is body composition, measured by total body DXA-scan.
The DXA scan looks at bone mass, visceral fat, subcutaneous fat, lean muscle mass, abdominal circumference, and weight.
In the hemodialysis study, the main outcome is the myofibrillar fractional synthetic rate, which is a measure of muscle protein building.
The study also looks at hemodynamic effects, meaning effects on circulation and blood flow.
What patients should know
These trials are focused on specific groups, so not everyone would be eligible.
One study is for women with Turner syndrome, while the other is for chronic hemodialysis patients with muscle protein turnover concerns.
The data do not describe SODIUM HYDROXIDE as a stand-alone treatment goal; instead, it appears as part of a larger study product or combination.
Because the trials measure specific outcomes, they are designed to answer research questions about how the interventions affect the body in these patient groups.