ACTRN12621001100886RecruitingPhase 4
Investigating the effect of topical testosterone cream on bone loss and sexual function in women with premature ovarian insufficiency (POI) and early menopause (EM): a randomized, double blind, placebo-controlled trial.
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Monash University
- Enrollment
- 116
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (—)
- Sex
- Female
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
- •16. been considered by the Clinical Investigator (CI) to be unsuitable for participation in the study.
Investigators
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