A Phase II open-label pilot study to assess the effects of Testosterone Metered Dose Transdermal System (MDTS) administration on cognitive function in women

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000429358

Enrollment

Registered

2008-08-26

Start date

2007-09-18

Completion date

Unknown

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

A 26 week study to assess the effects of transdermal testosterone spray on cognitive function in healthy postmenopausal women aged 45-60 years.

Interventions

administration of 180microlitres transdermal testosterone spray daily for 26 weeks

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

45 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy postmenopausal women on stable non-oral oestrogen for at least 8 weeks

Exclusion criteria

history of cancer exluding non-melanotic skin cancer, significant heart, liver, kidney, endocrine disease or neurological disease, androgenic alopecia, current androgen or anti-androgen therapy, epilepsy, seizures, psychiatric illness, previous neurological or head injury, intellectual disability, uncontrolled hypertension, recent major gynaecological surgery, total tesosterone levels higher than the upper limit of the normal reference range for young premenopausal women, alcohol consumption of greater than 3 standard drinks per day, if uterus in situ use of progestin other than Mirena intra-uterine device, presence of implanted metallic material or devices, severe claustrophobia

Outcome results