The effect of transdermal testosterone patch (Intrinsa registered trademark) on cognitive performance in older postmenopausal women: a randomized placebo controlled trial over 26 weeks.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000029099

Enrollment

120

Registered

2010-01-11

Start date

2010-07-27

Completion date

2012-03-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Circulating testosterone levels in young healthy women exceed those of oestrogen and by the time women reach their 40s, their blood testosterone levels are about half those of women in their 20s. Restoration of testosterone levels in postmenopausal women to those of younger women improves several aspects of cognitive function using conventional tests of cognitive performance. More recently, in a pilot study of postmenopausal women given transdermal testosterone over a period of 26 weeks we observed improved verbal and visual learning and memory using highly sensitive measures of cognitive performance. The aim of this study is to use these sensitive measures of cognitive function, which can detect subtle changes in cognitive performance in well older individuals, in a randomised placebo-controlled trial to determine whether restoration of blood testosterone levels in older women to those of premenopausal women over 26 weeks enhances cognitive performance when compared with placebo therapy.

Interventions

transdermal testosterone patch (Intrinsa) 300 mcg, 1 patch applied twice weekly (patch applied to skin for 3.5 days), duration 26 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

65 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy postmenopausal women aged 65 to 70 years, on no hormone therapy (HRT).

Exclusion criteria

Any hormone therapy in the past 12 months (i.e. systemic oestrogen, testosterone, tibolone, or dehydroepiandrosterone acetate [DHEA]) excluding topical vaginal oestrogens. Past or present history of cancer, significant disease of the heart, liver, or kidneys, serious endocrine (hormone) disorder, androgenic alopecia (loss of scalp hair in a male pattern) or use of anti-androgen therapy, epilepsy, seizures, psychiatric illness including depression, neurological (nerve, spinal cord or brain) injury including head injury, intellectual disability, uncontrolled hypertension (high blood pressure), major gynaecological (ovarian, vaginal, cervical, womb or uterus) surgery in the preceding 3 months, levels of testosterone higher than the normal reference range for young premenopausal women, use of androgen or anti-androgen therapy, the use of other medication that may interfere with the results of the study. Regular consumption of an excess of alcohol (more than 3 standard drinks per day)

Outcome results