Preventing bone loss and restoring sexual function in women after menopause: a randomised, double blind, placebo-controlled trial

A multi-centre randomised controlled trial evaluating whether testosterone therapy can improve libido and prevent bone loss in postmenopausal women.

RECRUITMENT NOW COMPLETED

Background

Menopause occurs on average at the age of 51 years. By this time women do not produce sufficient estrogen or testosterone necessary for good bone health. At menopause, women on average lose 6-8% of their bone mass. As a result, postmenopausal women have an increased risk of osteoporosis and fractures.

1 in 3 women experience loss of sexual desire and arousal after menopause.

There is some evidence that the addition of testosterone to estrogen replacement therapy might prevent bone loss and restore sexual function in women with early menopause, but further evidence from well conducted trials is still needed.

Why are we doing this research?

This study aims to investigate whether supplementing testosterone in postmenopausal women to levels similar to that of premenopausal women can improve sexual function and bone mineral density.

Who can participate?

We are seeking postmenopausal women aged less than 55 years who are using estrogen replacement to participate in this study.

What does the study involve?

Participation involves application of a cream containing either testosterone or placebo every day for 12 months. This is a safe treatment that has been approved for women.

Throughout the 12 month study period participants will be required to attend the study centre up to 5 times. Blood is collected at each visit to measure hormone levels and markers of bone turnover. Bone mineral density scans are performed at the start of the study and at 12 months. Sexual function is assessed via questionnaire.

Study visits can be conducted in either Melbourne or Perth.

Recruitment for this study is now completed. For further information about the study, please contact us:

Women’s Health Research Program
Monash University
Phone: +61 3 9903 0836
Email: womens.health@monash.edu

This study is approved by the Monash University Human Research Ethics Committee