None listed
Conditions
Brief summary
In order to investigate the equi-efficacy of DHEA (orally administered via oral strip technology) versus standard troche delivered DHEA. Oral Strip Technology (OST) encompasses a rapid drug releasing product that is presented as a dissolvable strip orally applied. This technology has been used for local action, rapid release products and for bucco-adhesive systems that are retained for longer periods in the oral cavity to release a drug in a controlled fashion. OST offers an alternate platform for molecules that undergo first pass metabolism and for delivery of compounds.
Interventions
In order to investigate the equi-efficacy of DHEA (orally administered via oral strip technology) versus standard troche delivered DHEA. Oral Strip Technology (OST) encompasses a rapid drug releasing product that is presented as a dissolvable strip orally applied. This technology has been used for local action, rapid release products and for bucco-adhesive systems that are retained for longer periods in the oral cavity to release a drug in a controlled fashion. OST offers an alternate platform f
In order to investigate the equi-efficacy of DHEA (orally administered via oral strip technology) versus standard troche delivered DHEA. Oral Strip Technology (OST) encompasses a rapid drug releasing product that is presented as a dissolvable strip orally applied. This technology has been used for local action, rapid release products and for bucco-adhesive systems that are retained for longer periods in the oral cavity to release a drug in a controlled fashion. OST offers an alternate platform for molecules that undergo first pass metabolism and for delivery of compounds. Allocation: Non-Randomised, Treatment: 6 week run-in period on standard treatment (DHEA Troches 'lozenges'); 6 weeks treatment of new delivery system (DHEA oral strips) Endpoint Classification: Efficacy and safety, Patient-specific dosing as per GPs instruction in the range of 100–150 mg / day oral dose.
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Male, > 18 years of age at time of entry on study 2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment 3) Have been prescribed and taking DHEA for at least 6 months duration 4) Participants agree to adhere to the study protocol 5) Being treated for Adrenal Fatigue 6) Symptoms are controlled with current hormone therapy 7) BMI specification in the range of 15–30 kg/m2 8) No history of malignant diseases
Exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs 2) Taking dopaminergic or anti-dopaminergic medications, clonidine, psychotropic medications, narcotic analgesics, antihistamines used chronically 3) The use of any dietary and herbal supplements including soy supplements 4) The use of illicit drugs
Outcome results
None listed