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Archivos de Medicina (Manizales)

2022, Number 2

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Arch Med 2022; 22 (2)

Promestriene: evaluation of its use and impact on estradiol serum levels in women with breast cancer and genitourinary syndrome of menopause. Armenia, Colombia, 2017-2018

Espitia HFJ

Language: Spanish
References: 39
Page: 206-220
PDF size: 322.86 Kb.


ABSTRACT

Objective: to assess the variations in serum estradiol levels in women with breast cancer and genitourinary syndrome of menopause, after the administration of local intravaginal promestriene. Materials and methods: randomized, double-blind, controlled clinical trial. 92 women older than 40 years, treated for HER2-positive breast cancer, resident in Armenia, Colombia; with symptoms of genitourinary syndrome of menopause (SGUM), six months after completing oncological therapy; between March 2017 and March 2018. Postmenopausal status was defined as 12 months of amenorrhea or 6 months of amenorrhea with serum FSH levels ≥ 40 mIU / mL or estradiol ‹30 pg / mL. Two groups were assigned: “A” (n = 45, promestriene) and “B” (n = 47, placebo). Those in group “A” received 10 mg intravaginally, per day, for 21 consecutive days, continuing 10 mg weekly for three months, then every 2 weeks until the end of the study. Those in group “B” received placebo in the same way. The serum concentration of estradiol, sex hormone transporter globulin, free and total testosterone, as well as follicle-stimulating hormone and lute-stimulating hormone (at the start of therapy, then every three months, and at the end of the study at twelve months) were measured. Results: the mean age was 55.26 ± 5.28 years. At the beginning, there were no differences regarding the concentration of estradiol 29.37 ± 8.46 pg / mL (promestriene); 28.29 ± 7.38 pg / mL (placebo), p› 0.05. At the end of the study, the results showed no statistically significant differences between both groups: 33.16 ± 7.53 pg / mL versus 30.75 ± 6.93 pg / mL, respectively (p› 0.05). Conclusions: local hormonal therapy with promestriene, in the treatment of genitourinary syndrome of menopause, in women with a history of breast cancer, provides clinical evidence of its efficacy and safety, with a negligible impact on estradiol serum levels.


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