None listed
Conditions
Brief 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.
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
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
We will include women who: 1. have an established diagnosis of POI/EM as diagnosed by 4/12 amenorrhea and follicle stimulating hormone (FSH) levels in menopausal range on 2 occasions > 6/52 apart before 45 years of age, or women who have had a bilateral oophorectomy before 45 years of age 2. are aged between 18 and less than 45 years at the screening visit. 3. have been on a stable dose of estrogen replacement therapy (ERT) for at least 3 months with a dose equivalent to at least any of a 50mcg transdermal estradiol (E2) patch, daily 1mg transdermal E2 gel, daily 0.625mg/day of oral conjugated estrogen, daily 2mg/day of oral E2, a current E2 implant, or taking an E2-containing oral contraceptive pill (OCP) 4. have a negative pregnancy test at screening (not required for hysterectomised /oophorectomised women) 5. have a clinically acceptable cervical cancer screening test, if the cervix is present within the time frame of usual screening 6. are available for the entire study period and willing to adhere to participate in the study by providing written informed consent
Exclusion criteria
Women will be excluded if they are found on screening to have: 1. other known metabolic bone disease or a condition associated with osteoporosis such as rheumatoid arthritis, malabsorption, or anti-estrogen therapy 2. 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 3. a body mass index <18 or >38 kg/metre2 4. a Beck Depression Inventory -II (BDI-II) score on screening > 28 i.e., severe depression 5. developed POI post-chemotherapy / an estrogen sensitive cancer 6. used recent androgen therapy (T implant <16 weeks, transdermal T cream <8 weeks, tibolone 7. <12 weeks, oral T <4 weeks, injected T <6 weeks, oral dehydroepiandrosterone (DHEA) < 4 weeks) 8. taken an OCP containing ethinylestradiol/ other synthetic estrogen in the prior 3 months 9. 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 10. any major illness requiring hospitalization within the prior 6 months. 11. undiagnosed vaginal bleeding 12. moderate to severe acne or hirsutism, have used antiandrogen therapy for acne or hirsutism in the preceding 5 years, have androgenic alopecia 13. 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, mirtazapine, phosphodiesterase type 5 inhibitors, testosterone, dehydroepiandrosterone, ginkgo biloba, maca root, stimulants, cocaine, cannabis, or other drugs of abuse, serotonin-norepinephrine reuptake inhibitors. systemic antiandrogen therapy (spironolactone, cyproterone acetate, finasteride, minoxidil). 14. alcohol consumption > 3 standard drinks per day 15. an abnormal thyroid function (abnormal thyroid stimulating hormone (TSH) value confirmed by a free thyroxine (T4) outside laboratory range) 16. been considered by the Clinical Investigator (CI) to be unsuitable for participation in the study.
Outcome results
None listed