An Open Label Pilot Comparative Clinical Trial of Dehydroepiandrosterone (DHEA) Efficacy Administered as a Troche versus Oral Strips in Males with Adrenal Fatigue.

Completed

• Conditions: Hormone replacement; Adrenal fatigue; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12616001048471
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weekly; Quality of Life Questionnaire assessed using (MENQOL-intervention) and GP/Nurse-administered Modified Kupperman Index Questionnaire<br><br>[Weekly questionnaires assessing quality of life];Saliva Mane (morning) DHEA [morning samples collected at baseline (T0), Week 6, Week 12 post commencement of study treatment];Serum Estrone (E1)[Baseline (T0), Week 6, Week 12 blood samples post commencement of study treatment ]

Secondary Outcome Measures

Name	Time	Method
composite outcome; serum Urea/ELFT/FBC <br>[Baseline (0), Week 6, Week 12 blood draws];composite outcome; BP, Waist:Hip ratio, Weight measured<br>[Baseline (0), Week 6, Week 12 measurements. BP measured by sphygmomanometer, Waist:Hip ratio measured by tape measure, weight by scales. ];Primary composite outcome; Serum Testosterone, DHEA, Androstenedione[Baseline (T0), Week 6, Week 12 blood samples post commencement of study treatment];Primary outcome: Cortisol[Serum samples collected at baseline (T0), Week 6, Week 12 post commencement of study treatment];primary outcome: Estradiol (E2)[blood samples collected baseline (0), Week 6, Week 12 post commencement of study treatment];primary outcome: Progesterone[blood samples taken baseline (0), Week 6, Week 12 post commencement of study treatment]