ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000404527

Ethics application status

Approved

Date submitted

13/09/2006

Date registered

14/09/2006

Date last updated

20/04/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

A randomised placebo-controlled trial of testosterone undecanoate in obese men as adjuvant therapy for a weight loss program

Scientific title

A randomised placebo-controlled trial of testosterone undecanoate in obese men as adjuvant therapy for a weight loss program

Secondary ID [1]

.

Universal Trial Number (UTN)

Trial acronym

OSA-T

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obstructive Sleep Apnea (OSA)

Condition category

Condition code

Respiratory

Sleep apnoea

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena (OSA) as adjunctive therapy for a weight loss programme.The study will be conducted on an ambulatory basis and involve OSA subjects who are about to commence a standard weight reduction program. Once deemed eligible for the study, at a Screening visit, patients will report to the laboratory every 6 weeks for 18 weeks. They will receive three injections of testosterone (3000mg in total) undecanoate at 0, 6 and 12 weeks. In addition, whilst reporting patients will undergo a variety of assessments including overnight polysomnographies at weeks 0, 6 and 18 weeks. Patient will then reassessed in recovery, at one year

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo oil

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome that will be measured is weight (kg) before and after treatment.

Timepoint [1]

Weight will be measured at 0 and 18 weeks.

Secondary outcome [1]

Body composition (bioimpedance, DEXA (bone densitometry), single-cut abdominal and thigh computed Tomography(CT)).

Timepoint [1]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [2]

Anthropometry (waist, hip, thigh, arm, neck circumferences and skinfold thickness).

Timepoint [2]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [3]

Basal metabolic rate

Timepoint [3]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [4]

Food intake and exercise diary

Timepoint [4]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [5]

Physical activity (Physical Activity Questionnaire, motion detection)

Timepoint [5]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [6]

Muscle strength (Jamar handgrip dynamometry)

Timepoint [6]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [7]

Insulin sensitivity (by Homeostasis Model Assessment, HOMA)

Timepoint [7]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [8]

Blood hormone concentrations (total and free testosterone, estradiol, sex hormone binding globulin (SHBG)

Timepoint [8]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [9]

Luteinising hormone (LH)

Timepoint [9]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [10]

Follicle-stimulating hormone (FSH)

Timepoint [10]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [11]

Quality of life /wellbeing (SF36, leading symptom scale)

Timepoint [11]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [12]

Sexual function [International Index of Erectile Function (IIEF)

Timepoint [12]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [13]

Brief Male Sexual Function Inventory (BMSFI)

Timepoint [13]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [14]

Motivation (compliance, completion).

Timepoint [14]

Outcome varibles will be measured whilst the subjects are reporting the laboratory.

Secondary outcome [15]

Sleep and breathing (overnight in-laboratory polysomnography)

Timepoint [15]

Sleep studies will be conducted at Baseline and then 7 weeks and 18 weeks after baseline.

Eligibility

Key inclusion criteria

No significant uncontrolled medical problems.

Minimum age

18 Years

Maximum age

Not stated

Sex

Males

Can healthy volunteers participate?

No

Key exclusion criteria

Severe OSA ((minimum oxygen saturation < 65% or RDI > 80) requiring immediate treatment due to severity or increased associated risk (eg Transport worker), Use of drugs that alter androgen action, Contraindications to testosterone therapy, Desire for paternity within the next 12 months, Participation in sports that ban testosterone and require drug monitoring, Psychiatric disorders or drug abuse unless well controlled,Chronic medical conditions likely to interfere with or influence study treatment or safety unless well controlled.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

A researcher not directly involved in this study will be responsible for the randomisation of subjects and maintaining the blind until after the data analyses are complete.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer generated randomisation list will be used.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

A researcher not directly involved in this study will be responsible for the randomisation of subjects and maintaining the blind. Subjects, therapists and assessors will be blinded to which group the subjects are randomised to.

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/09/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

60

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Schering AG Australia Pty Ltd

Address [1]

NA

Country [1]

Australia

Primary sponsor type

Other

Name

The Woolcock Institute of Medical Research

Address

431 Glebe Point Rd, Glebe NSW 2037

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Area Health Service- The Centre for Respiratory Failure and Sleep Disorders Royal Prince Alfred Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/09/2006

Ethics approval number [1]

X06-0133

Summary

Brief summary

This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena as adjunctive therapy for a weight loss programme. The aim of the study is to evaluate the additional effect of testosterone replacement on weight loss and motivation in obese (BMI>30kg/m2) men with obstructive sleep apnea undergoing a weight reduction program. The primary endopint is weight loss after 4.5 months with other secondary endpoints including body composition, anthropometry, physical activity, metabolic markers (eg insulin sensitivity, basal metabolic rate) and blood hormone concentrations.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Ms Sarah Newton-John

Address

PO Box M77 Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95156578

Fax

+61 2 95505865

Email

[email protected]

Contact person for scientific queries

Name

Ms Renee Crompton

Address

Level 7 Page Chest Pavilion Building 14
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95157546

Fax

+61 2 95575059

Email

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		First published: 18 April 2012 https://doi.org/10.... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Increased sexual desire with exogenous testosterone administration in men with obstructive sleep apnea: A randomized placebo-controlled study.	2016	https://dx.doi.org/10.1111/andr.12132

N.B. These documents automatically identified may not have been verified by the study sponsor.