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Trial registered on ANZCTR


Registration number
ACTRN12616001048471
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
5/08/2016
Date last updated
18/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label Pilot Comparative Clinical Trial of Dehydroepiandrosterone (DHEA) Efficacy Administered as a Troche versus Oral Strips in Males with Adrenal Fatigue.
Scientific title
An Open Label Pilot Comparative Clinical Trial of Dehydroepiandrosterone (DHEA) Efficacy Administered as a Troche versus Oral Strips in Males with Adrenal Fatigue.
Secondary ID [1] 289796 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone replacement 299698 0
Adrenal fatigue 299699 0
Condition category
Condition code
Metabolic and Endocrine 299635 299635 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295465 0
Treatment: Drugs
Comparator / control treatment
To evaluate the efficacy and safety of DHEA oral hormone strips in their equivalent therapeutic activity compared to standard DHEA treatment in a troche. 15 participants on troche for SIX weeks. 15 participants on strip for SIX weeks.
Control group
Active

Outcomes
Primary outcome [1] 299100 0
Weekly; Quality of Life Questionnaire assessed using (MENQOL-intervention) and GP/Nurse-administered Modified Kupperman Index Questionnaire

Timepoint [1] 299100 0
Weekly questionnaires assessing quality of life
Primary outcome [2] 299101 0
Saliva Mane (morning) DHEA
Timepoint [2] 299101 0
morning samples collected at baseline (T0), Week 6, Week 12 post commencement of study treatment
Primary outcome [3] 299133 0
Serum Estrone (E1)
Timepoint [3] 299133 0
Baseline (T0), Week 6, Week 12 blood samples post commencement of study treatment
Secondary outcome [1] 326165 0
composite outcome; serum Urea/ELFT/FBC
Timepoint [1] 326165 0
Baseline (0), Week 6, Week 12 blood draws
Secondary outcome [2] 326166 0
composite outcome; BP, Waist:Hip ratio, Weight measured
Timepoint [2] 326166 0
Baseline (0), Week 6, Week 12 measurements. BP measured by sphygmomanometer, Waist:Hip ratio measured by tape measure, weight by scales.
Secondary outcome [3] 326287 0
Primary composite outcome; Serum Testosterone, DHEA, Androstenedione
Timepoint [3] 326287 0
Baseline (T0), Week 6, Week 12 blood samples post commencement of study treatment
Secondary outcome [4] 326288 0
Primary outcome: Cortisol
Timepoint [4] 326288 0
Serum samples collected at baseline (T0), Week 6, Week 12 post commencement of study treatment
Secondary outcome [5] 326363 0
primary outcome: Estradiol (E2)
Timepoint [5] 326363 0
blood samples collected baseline (0), Week 6, Week 12 post commencement of study treatment
Secondary outcome [6] 326364 0
primary outcome: Progesterone
Timepoint [6] 326364 0
blood samples taken baseline (0), Week 6, Week 12 post commencement of study treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294175 0
Commercial sector/Industry
Name [1] 294175 0
Australian Custom Pharmaceuticals Pty Ltd
Address [1] 294175 0
Unit 1, 4 Endeavour Road, Caringbah, New South Wales, 2229.
Mail; PO Box 2954 Taren Point, NSW, 2229
Country [1] 294175 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, New South Wales 2015
Country
Australia
Secondary sponsor category [1] 293005 0
None
Name [1] 293005 0
Address [1] 293005 0
Country [1] 293005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295581 0
National Institute of Integrative Medicine
Ethics committee address [1] 295581 0
11-23 Burwood Rd, Hawthorn, Melbourne, VIC, 3122
Ethics committee country [1] 295581 0
Australia
Date submitted for ethics approval [1] 295581 0
30/03/2016
Approval date [1] 295581 0
01/04/2016
Ethics approval number [1] 295581 0
0034E_2016

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67846 0
Dr Denis Rebic
Address 67846 0
Wellmed. 23-27 Wellington Street, St Kilda, VIC, 3182
Country 67846 0
Australia
Phone 67846 0
+61 (3) 9510 7700
Fax 67846 0
Email 67846 0
drrebic@bigpond.net.au
Contact person for public queries
Name 67847 0
Mr Chris Ott
Address 67847 0
Wellmed. 23-27 Wellington Street, St Kilda, VIC, 3182
Country 67847 0
Australia
Phone 67847 0
+61 (3) 9510 7700
Fax 67847 0
Email 67847 0
nurse@wellmed.com.au
Contact person for scientific queries
Name 67848 0
Prof Luis Vitetta
Address 67848 0
Medlab Clinical, 66 McCauley Street, Alexandria, NSW 2015
Country 67848 0
Australia
Phone 67848 0
+61 (2) 8188 0311
Fax 67848 0
Email 67848 0
luis_vitetta@medlab.co

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary