Current Studies

We are currently recruiting for the following studies:

• Testosterone for Low Sexual Desire in Premenopausal and Perimenopausal Women: A randomized, double-blind, placebo-controlled trial – the SYBIL Study.
• Real-world sleep outcomes among women with vasomotor symptoms associated with menopause using fezolinetant (ADELE-AU) 

All studies have been approved by an independent Human Research Ethics Committee

Testosterone for Low Sexual Desire in Premenopausal and Perimenopausal Women: A randomized, double-blind, placebo-controlled trial – the SYBIL Study.

Are you:

• Bothered by Low Sexual Desire?
• Aged 35-50 years?

We invite you to join our study, to see whether testosterone can improve sexual desire in women. Participants will be randomly assigned to receive either testosterone therapy or placebo for 6 months. The study involves a health check, blood collection, and questionnaires during three in-person visits at WHRIA.

RECRUITING NOW IN MELBOURNE AND SYDNEY

A randomised controlled trial evaluating whether testosterone therapy can improve low sexual desire in premenopausal and perimenopausal women.

Background

Loss of sexual desire that causes women concern is one of the most common sexual issues for women. Low sexual desire may include lack of interest in sex, a loss of desire for sexual activity or loss of responsiveness, amongst others, which may be of sufficient concern to seek a treatment.

Testosterone has been shown to be an effective treatment of low sexual desire associated with personal distress in women after menopause. Small studies suggest testosterone therapy may improve sexual desire in premenopausal women, however the study findings are uncertain. Use in perimenopausal women has not been studied.

Why are we doing this research?

This study aims to investigate whether testosterone therapy can improve sexual desire in premenopausal and perimenopausal women who have experienced a loss of sexual desire.

Who can participate?

We are seeking healthy premenopausal and perimenopausal women aged 35-50 years who have experienced a loss of sexual desire that causes them concern.

What does the study involve?

Participants will be required to apply skin cream containing an approved testosterone treatment for women or an identical placebo every day for 6 months.

Participants will need to be able to attend up to three clinic visits at the Women’s Health Research Program at 553 St Kilda Road, Melbourne, or at the Women’s Health Research Institute of Australia at Level 12, 97-99 Bathurst St, Sydney.

You will undergo a health check, and at each visit we will collect blood to measure your hormone levels and ask you to complete questionnaires.

Register your interest in SYDNEY or MELBOURNE

Principal Investigator: Professor Susan Davis, Monash University, Melbourne
Co Investigators: Dr Julia Grant (Monash), Dr James Brown (WHRIA)
HREC ref number: 49154. Study Sponsor: Lawley Pharmaceuticals Pty Ltd

Contact [email protected] for more information

A real-world observational study describing sleep outcomes among women with vasomotor symptoms associated with menopause using fezolinetant in Australia

Vasomotor symptoms (VMS) are associated with sleep disturbance, mood changes, and decreased quality-of-life. Most Australian women experiencing VMS do not receive treatment. Menopausal hormone therapy is the standard-of-care, but may not be appropriate for everyone.

Fezolinetant is approved as a nonhormonal treatment option for moderate to severe VMS associated with menopause in many regions, including North America, Europe, Asia and Australia. To date, this is the first multicenter, single-arm, observational study to investigate sleep outcomes among women with VMS symptoms associated with menopause treated with fezolinetant in an Australian real-world setting.

You may be eligible for this real-world observational study if you

• are over 40 years of age
• have moderate to severe hot flushes disturbing your sleep
• have not taken fezolinetant medication (or been prescribed it in the past)

Contact [email protected] for more information

Dr James Brown Principal Investigator

HREC Approved Bellberry Limited ISN: 2693-MA-3608

Study Sponsor: Astellas Pharma Australia Pty Ltd.

For more information please contact us today.

Privacy Policy for Research Participants

Any information about you that is obtained in connection with a research study will remain confidential and will be disclosed only with your permission. To ensure confidentiality, your information will be identified only by initials, date of birth and a study allocated number. The results of the study may be published or disclosed to other people in a way that will not identify you. The study will be conducted in accordance all relevant national and international regulatory guidelines to minimise negative impact on participants. Your medical records insofar as they relate to this study may be reviewed by officials of government related bodies or of any commercial company involved in this study. However, no personal details will be released. All data will be stored by the Women’s Health & Research Institute of Australia, under controlled (locked) access. Data will be retained for a minimum of ten years. Materials (including paper documents and computer discs) will be destroyed using an industrial shredding process.