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.

Monash University0 sites116 target enrollmentAugust 18, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 18, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

Female

Sponsor

•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

•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