Efficacy and safety of ultra-low-dose Vagifem (10 mcg)

Chollet, Janet A

doi:10.2147/ppa.s22940

Cited by 20 publications

(14 citation statements)

References 13 publications

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“…3 The characteristic features of reduced estrogen are systemic including vasomotor symptoms and localized atrophy of the urogenital tract 3 The use of systemic hormone therapy in optimizing changes associated with the menopause was once accepted as the ideal approach; however, some studies have challenged this view which has led to the decrease in the use of high-dose systemic treatment and has increased the search for low-dose topical therapies. 4…”

Section: Introductionmentioning

confidence: 99%

The management of lower urogenital changes in the menopause

Singh

Herwijnen

Phillips

2013

Menopause International

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Currently, 25% of women seek the advice of a medical professional for symptoms related to the menopause. However, with an increasingly ageing and medically aware population, it is likely this proportion will grow. The main symptoms related to the menopause are systemic vasomotor and localized urogenital symptoms. Numerous forms of estrogen have been used to alleviate these symptoms. Further problems that increase during the menopause include incontinence, pelvic organ prolapse and recurrent urinary tract infections. This article reviews the process by which estrogen affects the tissues of the urogenital tract, what symptoms occur during this period and what modalities of treatments are available.

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Section: Introductionmentioning

confidence: 99%

The management of lower urogenital changes in the menopause

Singh

Herwijnen

Phillips

2013

Menopause International

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“…However, the dose regimen was not sufficient enough to maintain the increase in the percentage of superficial cells. This regimen of locally applied hormone for VA was successful with estrogens (Chollet, 2011), but not with oxytocin. Therefore, we planned for another study to use intravaginal oxytocin in a daily set in order to achieve the desired clinical and laboratory improvement in the features of VA. At the same time, we sought to determine the minimum effective dose for treating VA without causing serious side effects.…”

Section: Discussionmentioning

confidence: 96%

Defined serum- and xeno-free cryopreservation of mesenchymal stem cells

et al. 2014

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Mesenchymal stem cells (MSCs) have vast potential in cell therapy, and are experimentally used in the clinic. Therefore, it is critical to find a serum- and xeno-free cryopreservation method. The aim of this study was to compare two serum- and xeno-free cryoprotectants for MSCs. Adipose tissue MSCs (Ad-MSCs) and bone marrow MSCs (BM-MSCs) were cryopreserved in two cryoprotectants: the defined serum- and xeno-free STEM-CELLBANKER™ (CB) and 10 % dimethyl sulfoxide (DMSO) in a xeno-free serum replacement cell culture medium and compared to non-cryopreserved MSCs. MSCs cryopreserved in CB or DMSO had similar morphology and surface marker expression compared to their respective non-cryopreserved MSC. Ad-MSCs and BM-MSC in both cryoprotectant media exhibited reduced mean fluorescence intensity (MFI) for CD105, BM-MSCs for CD73 and Ad-MSC increased MFI for HLA class I compared to non-cryopreserved MSCs. Population doubling time of CB cryopreserved and non-cryopreserved Ad-MSCs was similar (38.1 ± 13.6 and 36.8 ± 12.1 h), but somewhat higher when cryopreserved in DMSO (42.2 ± 10.8 h). BM-MSCs had higher population doubling time (CB 47.7 ± 11.4 and DMSO 62.3 ± 32.9 h respectively, p < 0.05) compared to Ad-MSCs. The viability of Ad-MSCs was significantly higher after cryopreservation in CB compared to DMSO (90.4 ± 4.5 % vs. 79.9 ± 3.8 % respectively). Ad-MSCs and BM-MSCs retained their mesodermal differentiation potential when cryopreserved in both cryoprotectants. The characteristics of Ad-MSCs post-thawing are better preserved by CB than by DMSO in serum- and xeno-free medium. Furthermore, Ad-MSCs and BM-MSCs are differently affected by the cryoprotectants, which may have implications for cell therapy.

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“…Multiple studies have shown improvement in symptoms, vaginal mucosa health, and vaginal pH with the low-dose 10-mg estradiol vaginal tablet. 19 Vaginal tablets are inserted into the lower third of the vagina for optimal effect and to minimize endometrial stimulation. Eugster-Hausmann et al 20 conducted a study in which 58 postmenopausal women received either 10-mg or 25-mg estradiol vaginal tablets to study the pharmacokinetics.…”

Section: Vaginal Estrogen Testosterone and Dhea Therapymentioning

confidence: 99%

Managing Genitourinary Syndrome of Menopause in Breast Cancer Survivors Receiving Endocrine Therapy

Sussman

Kruse

Thacker

et al. 2019

JOP

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Patients with breast cancer receiving antiestrogen therapy, specifically aromatase inhibitors, often suffer from vaginal dryness, itching, irritation, dyspareunia, and dysuria, collectively known as genitourinary syndrome of menopause (GSM). GSM can decrease quality of life and is undertreated by oncologists because of fear of cancer recurrence, specifically when considering treatment with vaginal estrogen therapy because of unknown levels of systemic absorption of estradiol. In this article, we review the available literature for treatment of GSM in patients with breast cancer and survivors, including nonhormonal, vaginal hormonal, and systemic hormonal therapy options. First-line treatment includes nonhormonal therapy with vaginal moisturizers, lubricants, and gels. Although initial studies showed significant improvement in symptoms, the US Food and Drug Administration recently issued a warning against CO2 laser therapy for treatment of GSM until additional studies are conducted. In severe or refractory GSM, after discussing risks and benefits of vaginal hormonal therapy, the low-dose 10-μg estradiol-releasing intravaginal tablet or lower-dose 4 μg estrogen vaginal insert and intravaginal dehydroepiandrosterone (prasterone) are options for treatment, because studies show minimal elevation in serum estradiol levels and significant improvement in symptoms. The decision to offer vaginal estrogen therapy must be individualized and made jointly with the patient and her oncologist.

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Efficacy and safety of ultra-low-dose Vagifem (10 mcg)

Cited by 20 publications

References 13 publications

The management of lower urogenital changes in the menopause

The management of lower urogenital changes in the menopause

Defined serum- and xeno-free cryopreservation of mesenchymal stem cells

Managing Genitourinary Syndrome of Menopause in Breast Cancer Survivors Receiving Endocrine Therapy

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