About: Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial

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About: Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial
Creator	Campos-Delgado, Miriam Gil-Gil, Miguel Lidbrink, Elisabet Linde´n Hirschberg, Angelica Lindén Hirschberg, Angelica Nieto-Magro, Concepcio´n Presa-Lorite, Jesu´s Sa´nchez-Rovira, Pedro Sua´rez-Almarza, Javier
Source	PMC
abstract	OBJECTIVE: To assess the efficacy and safety of ultra-low dose 0.005% estriol vaginal gel in women with breast cancer receiving nonsteroidal aromatase inhibitors (NSAIs) and experiencing treatment-related vulvovaginal symptoms and signs. METHODS: Women with hormone receptor-positive early breast cancer receiving NSAIs were randomized to either estriol vaginal gel or placebo for 12 weeks. Vaginal maturation, vaginal pH, and total and individual scores of symptoms and signs of vulvovaginal atrophy were assessed at baseline and at weeks 3 and 12; sexual functioning was also evaluated using the Female Sexual Functioning Index (FSFI) questionnaire, as well as circulating estrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). RESULTS: Sixty-one women with a mean age of 59 years were included: 50 received 0.005% estriol vaginal gel and 11 received placebo. Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs. Active treatment also increased the total FSFI score and all the FSFI domains, with the exception of pain. Small oscillations were observed in FSH and LH, which remained within the postmenopausal range. Estriol levels increased initially and normalized by week 12, and estradiol and estrone remained mostly undetectable throughout the study. CONCLUSIONS: Ultra-low dose 0.005% estriol vaginal gel showed efficacy in improving the symptoms and signs of vulvovaginal atrophy. These results, together with minimal oscillations in hormonal levels throughout the treatment, support the use of ultra-low dose 0.005% estriol vaginal gel as a treatment option for vulvovaginal atrophy in women with breast cancer receiving NSAIs with an indication for treatment with vaginal estrogens.
has issue date	2020-02-10(xsd:dateTime)
bibo:doi	10.1097/gme.0000000000001497
bibo:pmid	32049923
has license	no-cc
sha1sum (hex)	e9a23427bf88a97498de1f67192dee9cac2798e0
schema:url	https://doi.org/10.1097/gme.0000000000001497
resource representing a document's title	Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial
has PubMed Central identifier	PMC7188038
has PubMed identifier	32049923
schema:publication	Menopause
resource representing a document's body	covid:e9a23427bf88a97498de1f67192dee9cac2798e0#body_text
is schema:about of	named entity 'signs' named entity 'assess' named entity 'gel' named entity 'nonsteroidal' named entity 'atrophy' named entity 'vaginal' named entity 'ASSESS' named entity 'VULVOVAGINAL' covid:arg/e9a23427bf88a97498de1f67192dee9cac2798e0 named entity 'vulvovaginal' named entity 'breast cancer' named entity 'placebo-controlled trial' named entity 'randomized' named entity 'symptoms and signs' named entity 'estriol' named entity 'phase II' named entity 'vulvovaginal atrophy' named entity 'aromatase inhibitors' named entity 'nonsteroidal' named entity 'GSM' named entity 'serum' named entity 'Austria' named entity 'urogenital' named entity 'ITT' named entity 'luteinizing hormone' named entity 'clinical evidence' named entity 'signs/symptoms' named entity 'aromatase inhibitors' named entity 'pairwise comparison' named entity 'estrone' named entity 'dyspareunia' named entity 'genitourinary' named entity 'adverse events' named entity 'symptom' named entity 'estriol' named entity 'estriol' named entity 'hormonal treatments' named entity 'symptoms and signs' named entity 'clinical characteristics' named entity 'estrogen deprivation' named entity 'placebo' named entity '12 weeks' named entity 'estriol' named entity 'estriol' named entity 'HER2' named entity 'physiological' named entity 'first-line therapy' named entity 'ECOG' named entity '12 weeks' named entity 'placebo' named entity 'nonmelanoma skin cancer' named entity 'postmenopausal' named entity 'placebo group' named entity 'NSAIs' named entity 'estriol' named entity 'quality of life' named entity 'follow-up' named entity 'mucosa' named entity 'estriol' named entity 'estrogenic' named entity 'estradiol' named entity 'menopausal symptoms' named entity 'clinical studies' named entity 'Vulvovaginal' named entity 'postmenopausal women' named entity 'herbal products' named entity 'postmenopausal women' named entity 'NSAI' named entity 'physical examination' named entity 'estrogens' named entity 'mucosal' named entity 'FSH levels' named entity 'placebo'

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