We are currently recruiting for the following studies:

  • Real-world sleep outcomes among women with vasomotor symptoms associated with menopause using fezolinetant (ADELE-AU) 
  • Potential treatment for painful intercourse 

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

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.

Potential treatment of women with painful penetrative intercourse – a topical cream (MiGel®

The study aim is to assess the effectiveness and safety of the application of a topical treatment combining two commonly used medicines for painful intercourse with penetration. Enrolment has now closed.

Data analysis will begin in June 2026

Participants need to be:

  • women aged 30 and over, living in Australia
  • have experienced pain in or around the vulva/vagina during sex for at least 3 months, 
  • are currently sexually active (including with self) or would like to be but can’t because of pain, 
  • have given birth at least once with no severe morning sickness, and 
  • are NOT currently pregnant or breastfeeding, and willing to avoid pregnancy during the study 

Dr Karen Chan Principal Investigator

HREC Approved Bellberry Limited

Application ID: 2024-08-1072
Principal Investigator: Karen Chan
Protocol Title: RANDOMISED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL ASSESSING THE EFFICACY OF MI-GEL IN THE TREATMENT OF WOMEN WITH VULVAL PAIN / ENTRY DYSPAREUNIA
Review Type: FULLBOARD
Approval Date: 02-Oct-24

For more information please contact us today.

If you have a specific enquiry for our WHRIA specialists

Click Here

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.

If you have a specific enquiry for our WHRIA specialists

Click Here
Last updated: 27 January 2026

© 2026 Women's Health & Research Institute of Australia. Privacy Policy | Terms of Use | Website by Phil Kurth