Study on Testosterone and Isopropyl Myristate for Women with Turner Syndrome
- Participants:Adults
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Isopropyl myristate is a chemically synthesised substance that belongs to the group of emollients — ingredients that soften and smooth the skin. It is not a medicine on its own in the usual sense, but it is authorised as an ingredient in medicinal skin products. In the United Kingdom, the NHS dictionary of medicines lists it in products such as Dermol cream, Dermol 200 shower emollient, Dermol 500 lotion, and bath additives containing liquid paraffin.[2] Isopropyl myristate is also known by the alternative spelling isopropyl myrisate.[2]
In the clinical trial described on this page, isopropyl myristate appears as the placebo component of a transdermal gel. A placebo is a substance with no active medical effect, used so that researchers can compare the effect of an active treatment against no treatment while keeping the study blinded.[1]
As an emollient, isopropyl myristate works by forming a layer on the skin that helps to keep moisture in and makes the skin feel softer. It is widely used in creams, lotions and bath products for this reason.[2] In the Turner syndrome trial, isopropyl myristate does not have a therapeutic effect of its own. It is included in the placebo gel to make the gel look, feel and smell like the active testosterone gel, so that participants and researchers cannot tell which treatment is being given.[1]
Isopropyl myristate is given by transdermal use, which means it is applied to the skin. In the Turner syndrome trial, the placebo gel containing isopropyl myristate is applied to the skin in the same way as the active testosterone gel.[1] The product records from the trial list isopropyl myristate at a strength of 2.7 mg per application.[1] In skin care products, isopropyl myristate is found in creams, lotions, shower emollients, bath additives and gels.[2]
One clinical trial listed in the EU Clinical Trials Information System involves isopropyl myristate. The trial is a Phase 2 interventional study in Turner syndrome, with 50 participants planned. Its status is authorised, meaning it has received approval to proceed.[1]
In this trial, isopropyl myristate is the placebo component of a transdermal gel. The study compares testosterone replacement therapy (TRT) given as a transdermal gel with a placebo gel. The placebo gel contains isopropyl myristate together with ethanol, carbomer 980 and sodium hydroxide, while the active gel is Androgel 25 mg.[1]
The main outcome measured in the trial is change in body composition, examined by total body dual-energy x-ray absorptiometry (DXA scan). This includes bone mass, visceral and subcutaneous fat mass, lean muscle mass, abdominal circumference and weight. The study also looks at endocrine, cardiovascular, neurocognitive and genomic effects of transdermal testosterone as a supplement to oestrogen replacement therapy in women with Turner syndrome.[1]
The trial does not measure any effect of isopropyl myristate itself. Its role is to serve as the inactive comparison, so that any changes seen in the testosterone group can be attributed to the testosterone rather than to the act of applying a gel.[1]
The source used for this page does not report side effects specifically for isopropyl myristate when used as an emollient or as a placebo in this trial. The trial record does not list side effects for the placebo gel.[1]
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