Investigating the effect of topical testosterone cream on bone loss and sexual function in postmenopausal women: a randomized, double blind, placebo-controlled trial
Monash University
116 participants
Feb 16, 2022
Interventional
Conditions
Summary
The purpose of this research is to determine whether the use of a topical testosterone cream prevents bone loss and improves sexual function in menopause women aged 18 to <55 years who are taking a standard dose of estrogen. We hypothesize that 0.5ml of testosterone cream, versus placebo, applied daily for 12 months will result in a clinical improvement in total hip bone mineral density in these women, and other markers of musculoskeletal health, as well as improvements in sexual function and reduced sexually associated personal distress. The purpose of this research is to determine whether the use of transdermal testosterone therapy, in a dose shown restores testosterone levels to those of premenopausal women, prevents bone loss and improves sexual function in menopause women who are taking the standard dose of estrogen.
Eligibility
Inclusion Criteria6
- We will include women who:
- have an established diagnosis of menopause
- are aged aged 18 to< 55 years on day of (Visit 1) screening
- For women aged <45 years, must have been on a stable dose of ERT for at least 3 months with a dose equivalent to at least any of a 50mcg transdermal E2 patch, daily 1mg transdermal E2 gel, daily 0.625mg/day of oral conjugated estrogen, daily 1 mg/day of oral E2, a current E2 implant, or taking an E2-containing oral contraceptive (OCP). For women aged 45-54 years, must have been on a stable dose of ERT for at least months with a dose equivalent to at least any of a 25mcg transdermal E2 patch, daily 0.5mg transdermal E2 gel, daily 0.3mg/day of oral conjugated estrogen, daily 0.5 mg/day of oral E2, a current E2 implant, or taking an E2-containing oral contraceptive (OCP).
- have a negative pregnancy test at screening (not required for hysterectomised/oophorectomised women)
- are available for the entire study period and willing to adhere to participate in the study by providing written informed consent
Exclusion Criteria18
- Women will be excluded if they are found on screening to have:
- other known metabolic bone disease or a condition associated with osteoporosis such as rheumatoid arthritis, malabsorption, or anti-estrogen therapy
- taken, or be taking, any drug known to affect bone metabolism such as bisphosphonates, denosumab, systemic corticosteroids, antineoplastic drugs, thiazide diuretics, anti-epileptic drugs, heparin
- a body mass index less than 38 kg/metre2
- a BDI-II score on screening > 28 i.e., severe depression
- developed menopause post-chemotherapy / an estrogen sensitive cancer
- used recent androgen therapy (T implant <16 weeks, transdermal T cream <8 weeks, tibolone <12 weeks, oral T <4 weeks, injected T <6 weeks, oral DHEA < 4 weeks)
- taken an OCP containing ethinylestradiol/ other synthetic estrogen in the prior 3 months
- a pre-randomisation sex hormone binding globulin (SHBG) level 2 x the upper limit of
- normal for the local laboratory as an elevated SHBG interferes with the efficacy of T therapy
- any major illness requiring hospitalization within the prior 6 months
- undiagnosed vaginal bleeding
- moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia
- taken any drugs or dietary supplements that, in the Investigator’s opinion, may affect the participant’s sexual desire including, but not limited to, flibanserin, bremelanotide, bupropion, buspirone, phosphodiesterase type 5 inhibitors, testosterone, dehydroepiandrosterone, ginkgo biloba, maca root, stimulants, cocaine, cannabis, or other drugs of abuse. systemic antiandrogen therapy (spironolactone, cyproterone acetate, finasteride, minoxidil)
- alcohol consumption > 3 standard drinks per day
- an abnormal thyroid function (abnormal TSH value confirmed by a free T4 outside laboratory
- range)
- been considered by a CI to be unsuitable for participation in the study.
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Interventions
Application of active treatment, 1% testosterone cream, 0.5ml (10mg/ml), or placebo cream applied transdermally daily to upper thigh or lower torso by participant for 12 months. Dosing may be modified by an appointed independent Study Safety Monitor (a clinician experienced in T therapy for women) who will have access to the randomisation code and will review each participant’s 12 and 26-week T level (measured locally). For any woman with a T level 1.5 times the upper limit of the premenopausal range for each site’s T assay, the Safety Monitor will request both the participant with high T, as well as a randomly selected participant from the same study site on placebo with a recent blood draw, decrease the amount of T cream applied (by 25%) and both to have repeat blood levels after 3 weeks. This ensures dose adjustment without unblinding. Compliance will be assessed by collection and weighing of returned cream containers at week 12, week 26 and week 52 after commencement of treatment.
Locations(3)
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ACTRN12621001100886