The effect of transdermal testosterone gel300mcg daily on cognitive performance in older postmenopausal women: a placebo controlled trial over 26 weeks
Monash University
120 participants
Mar 24, 2010
Interventional
Conditions
Summary
The Primary Objective of this study is to determine whether treatment of older postmenopausal women (55 to 65 years old) with transdermal testosterone gel (Libigel Registered Trademark) which delivers 300mcg of testosterone/day, improves cognitive performance. Study Hypotheses That restoration of testosterone levels in older postmenopausal women to levels seen in younger women will result in improved verbal and visual learning and memory using a highly sensitive measure of cognitive performance (Cogstate Trademark). That this research will provide the first substantial data indicating that restoration of testosterone levels to those of younger women may protect against/delay the onset of cognitive decline.
Eligibility
Inclusion Criteria5
- Women:
- who are aged 55 to 65 years and have not used systemic oestrogen, testosterone, tibolone or dehydroepiandrosterone(DHEA) therapy for at least 12 months.
- who are at least 12 months postmenopausal. Postmenopausal status will be defined as surgical menopause, natural menopause and >12months of amenorrhea. Hysterectomised women with intact ovaries will be classified as postmenopausal if 58 years and over and if <58 years will require a follicle stimulating hormone (FSH) level > 20IU/L.
- who have evidence of a Pap smear and mammographic screening in the past 24 months with no changes of concern.
- who have provided informed consent by signing the International Regulatory Board (IRB)-approved consent agreement.
Exclusion Criteria26
- Women with any of the following:
- (a) history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
- (b) any clinically significant skin abnormalities in the area of study drug application (Skin Irritation Scale must < 1 at Visit 2).
- (c) hot flushes and/or night sweats for which the potential participant wants treatment
- (d) Sex Hormone Binding Globulin (SHBG) level < 12nmol/L
- (e) undiagnosed genital bleeding
- (f) Body Mass Index (BMI) <18 or > 40kg/m2
- (g) found on the screening to have a Center for Epidemiological Studies Depression Scale (CES-D) score =16.
- (h) any mammogram results in the past 24 months with pre-cancerous or cancerous findings or any finding that requires follow up in the next 12 months.
- (i) any abnormal Pap Smear results in the past last 24 months
- (j) have received anti-androgen therapy or topical minoxidil for alopecia within the last 5 years.
- (k) have taken any systemic estrogen, including vaginal conjugated equine estrogen, or estrogen progestin therapy within 12 months prior to screening. (Current use of non-systemic vaginal estrogen or phytoestrogens is acceptable.)
- (l) have received oral, topical, vaginal or patch, implantable or injectable androgen therapy within 12 months prior to screening
- (m) have used within the 12 weeks prior to screening any of the following medications/preparations that may interfere with the study purpose: systemic corticosteroids (acute use for fewer than 7 days is accepted) or Selective Estrogen Receptor Modulators (SERMs), including tamoxifen.
- (n) a known severe psychiatric illness.
- (o) current use of an anti-depressant therapy or antidepressant treatment within the last 3 months
- (p) neurological disorder that would affect cognition, including history of significant head injury with loss of consciousness, epilepsy, cerebral tumor, stroke and previous intracranial surgery of any kind, Parkinson’s disease, multiple sclerosis.
- (q) intellectual disability
- (r) uncontrolled hypertension, Systolic blood pressure (BP) > 160 and/or Diastolic BP > 90
- (s) a history of cancer except for treated superficial basal cell carcinoma and squamous cell carcinoma of the skin.
- (t) any history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis
- (u) any serious endocrine disorder with systemic disease. Women with a history of thyroid disease should provide evidence that they are currently euthyroid.
- (v) known acute or chronic liver disease (bilirubin > x2 the upper limit of normal (ULN), and/or alanine transferase > x3 ULN, aspartate aminotransferase AST> x3 ULN, and/or alkaline phosphatase > x3 ULN
- (w) insulin dependent diabetes mellitus, acute / chronic renal, liver, cardiovascular disease or any other chronic major illness which would impair overall health and wellbeing
- Women who, in the opinion of the investigator, are a poor medical or psychiatric risk for treatment in a research protocol.
- Women who have participated in a medical or surgical research protocol in the preceding 28 days.
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Interventions
administration of 300mcg of transdermal testosterone gel once daily to the upper arm for 6 months
Locations(1)
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ACTRN12609000981224