Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis

Chollet, Janet A; Carter, Gloria; Meyn, Leslie A.; Mermelstein, Fred H.; Balk, Judith

doi:10.1097/gme.0b013e3181a06c80

Cited by 27 publications

(13 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…(32) A case series of a novel intravaginal estriol/progesterone suppositories reported improvement from baseline in MENQOL over 6 months, largely due to improvements in the sexual function domain, but this investigation is limited by the absence of a comparable control group. (33)…”

Section: Discussionmentioning

confidence: 99%

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial

et al. 2018

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 99%

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Thus, since safety is a major issue, only less potent estrogens should be considered for vaginal treatment. E3, a less potent estrogen than E2, the vaginal application of 1 mg in postmenopausal women with vaginal atrophy did not increase serum levels at 2 weeks, 3 months, and 6 months as compared to controls, and endometrial biopsies showed no proliferation [23]. …”

Section: Introductionmentioning

confidence: 99%

Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor®) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study

Donders

Neven

Moegele

et al. 2014

Breast Cancer Res Treat

103

View full text Add to dashboard Cite

Phase I pharmacokinetic (PK) study assessed circulating estrogens in breast cancer (BC) patients on a non-steroidal aromatase inhibitor (NSAI) with vaginal atrophy using vaginal ultra-low-dose 0.03 mg estriol (E3) and Lactobacillus combination vaginal tablets (Gynoflor®). 16 women on NSAI with severe vaginal atrophy applied a daily vaginal tablet of Gynoflor® for 28 days followed by a maintenance therapy of 3 tablets weekly for 8 weeks. Primary outcomes were serum concentrations and PK of E3, estradiol (E2), and estrone (E1) using highly sensitive gas chromatography–mass spectrometry. Secondary outcomes were clinical measures for efficacy and side effects; microscopic changes in vaginal epithelium and microflora; and changes in serum FSH, LH, and sex hormone-binding globulin. Compared with baseline, serum E1 and E2 did not increase in any of the women at any time following vaginal application. Serum E3 transiently increased after the first application in 15 of 16 women, with a maximum of 168 pg/ml 2–3 h post-insertion. After 4 weeks, serum E3 was slightly increased in 8 women with a maximum of 44 pg/ml. The vaginal atrophy resolved or improved in all women. The product was well tolerated, and discontinuation of therapy was not observed. The low-dose 0.03 mg E3 and Lactobacillus acidophilus vaginal tablets application in postmenopausal BC patients during AI treatment suffering from vaginal atrophy lead to small and transient increases in serum E3, but not E1 or E2, and therefore can be considered as safe and efficacious for treatment of atrophic vaginitis in BC patients taking NSAIs.

show abstract

“…This is most commonly due to the menopause and is associated with specific symptoms, the most common of which are vaginal dryness, itching, irritation and dyspareunia. 7–23 Urogenital atrophy also impacts on the tissue quality in the bladder and urethra, but in affected women, the changes are more easily observed and quantified in the vulva and vagina. 24…”

Section: Methodsmentioning

confidence: 99%

“…Findings in both studies are compounded by the absence of a simple, accessible and objective diagnostic method, which would inform accurate numbers of affected women and provide a means of assessing response to treatment both in clinical practice and also in clinical trials. 6–10 This needs to be developed and validated before raising awareness through education can have any significant impact on the number of women receiving an accurate diagnosis and appropriate treatment. This review paper examines the available evidence relating to diagnostic accuracy of urogenital atrophy and sets the scene to consider what measures need to be taken to improve the utility of current commonly used methods.…”

Section: Introductionmentioning

confidence: 99%

Urogenital atrophy: The ‘unknown factors’ challenging current practice

Briggs

Hapangama

2021

Post Reprod Health

View full text Add to dashboard Cite

Urogenital atrophy occurs as a result of the effect of estrogen deficiency on the tissue quality in the vulva, vagina, urethra and bladder. It is a common consequence of the menopause, with possibly up to 80% of women experiencing symptoms. Despite a number of different diagnostic methods, there is no validated objective method by which to confirm the diagnosis in clinical practice and research settings. Education, for women and clinicians, is called for to support diagnosis and treatment. However, before this can be of global benefit, development of an accessible and reproducible diagnostic test is required. Current assessment methods include routine history and clinical examination, with the clinician’s opinion based on their subjective observations. A vaginal smear to assess the ratio of superficial to parabasal cells and measurement of the pH of the vaginal secretions is more commonly used in research settings. A number of formulae have been postulated to facilitate the diagnosis including the Vaginal Health Index, the Vulval Health Index, the Genitourinary Syndrome of the Menopause assessment tool, the Genital Health Clinical Evaluation and vaginal biopsy and assessment of the vaginal microbiome. However, none of these potential methods of assessment has been validated. This article focuses on what we do not know about urogenital atrophy including the prevalence, the most appropriate terminology, aetiology, pathogenesis and the most objective and reproducible method of assessment.

show abstract

Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis

Abstract: Intravaginal administration of a combination estriol and progesterone agent to women with atrophic vaginitis may represent a safe and effective alternative to systemic hormone replacement, although this study was not adequate to provide proof of efficacy given that it was uncontrolled.

Cited by 27 publications

References 14 publications

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial

Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial

Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor®) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study

Urogenital atrophy: The ‘unknown factors’ challenging current practice

Contact Info

Product

Resources

About