Investigating the effect of topical testosterone cream on bone loss and sexual function in women with premature ovarian insufficiency and early menopause: a randomized, double blind, placebo-controlled trial..

Phase 4

Recruiting

• Conditions: Osteoporosis; Sexual dysfunction; Primary Ovarian Insufficiency; Early menopause; Musculoskeletal - Osteoporosis; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12621001100886
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-18
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 116

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified