Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study

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Jonasson, Aino FianuKarolinska Institutet,Karolinska Inst, Dept Clin Sci Intervent & Technol, Div Obstet & Gynecol, S-17177 Stockholm, Sweden (författare)

Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital® Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy : A Randomized, Double-Blind Controlled Study

Artikel/kapitelEngelska2020

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DOVE MEDICAL PRESS LTD,2020
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LIBRIS-ID:oai:DiVA.org:uu-424585
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-424585URI
https://doi.org/10.2147/MDER.S265824DOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:233116956URI
https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-176175URI

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Språk:engelska
Sammanfattning på:engelska

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Purpose: The primary objective was to compare the efficacy of 12 weeks of daily treatment with Aqueous Hypromellose-based vaginal (Vagivital®) gel versus Aqueous Hypromellose-based vaginal gel plus 400 IU oxytocin gel in reducing the severity of the most bothersome vulvovaginal atrophy symptoms (MBS: itching, dysuria, bleeding, and pain/discomfort during vaginal sexual activity) observed at baseline. The secondary objectives were to evaluate the other vulvovaginal atrophy symptoms, vaginal pH, superficial squamous cells, and the safety and tolerability of both gels.Patients and Methods: This double-blind, randomized study evaluated the safety and efficacy of subjects randomly assigned to 12 weeks of daily intravaginal oxytocin gel (n=79) or Aqueous Hypromellose-based vaginal gel (n=78). The efficacy evaluation was performed using data from all included subjects who fulfilled entry criteria.Results: Both treatments induced statistically significant reductions in the severity of the MBS from baseline until 4 weeks (Vagivital mean reduction 0.90, p=0.0000; Oxytocin mean reduction 0.82, p=0.0000) and 12 weeks post baseline (Vagivital mean reduction 1.28, p=0.0000; Oxytocin mean reduction 1.16, p=0.0000), but the reduction of MBS severity was not significantly different between the treatment groups at either time point. No serious adverse events were reported in the Aqueous Hypromellose-based vaginal gel group during the treatment period, but one (breast cancer) was reported in the oxytocin gel group (assessed as unlikely related to the study compound).Conclusion: Significant reductions in the severity of the MBS were seen in both the Aqueous Hypromellose-based vaginal gel and the oxytocin gel groups, but with no significant differences in severity reduction seen between the groups. Both gels were safe and well tolerated. Given the benefits of avoiding the use of hormones, Aqueous Hypromellose-based vaginal gel is an attractive first choice in the treatment of postmenopausal women with vulvovaginal atrophy symptoms.

Ämnesord och genrebeteckningar

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Reproduktionsmedicin och gynekologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Obstetrics, Gynaecology and Reproductive Medicine hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
most bothersome vulvovaginal atrophy symptoms
MBS
non-hormonal therapy
dyspareunia
vaginal dryness

Biuppslag (personer, institutioner, konferenser, titlar ...)

Bixo, MarieUmeå universitet,Obstetrik och gynekologi(Swepub:umu)mabi0001 (författare)
Sundström Poromaa, Inger,1964-Uppsala universitet,Reproduktiv hälsa(Swepub:uu)inspo702 (författare)
Åstrom, MikaelStatCons, Malmö, Sweden (författare)
Karolinska InstitutetKarolinska Inst, Dept Clin Sci Intervent & Technol, Div Obstet & Gynecol, S-17177 Stockholm, Sweden (creator_code:org_t)

Sammanhörande titlar

Ingår i:Medical Devices: DOVE MEDICAL PRESS LTD13, s. 339-3471179-1470

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Av författaren/redakt...: Jonasson, Aino F ...; Bixo, Marie; Sundström Poroma ...; Åstrom, Mikael

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Reproduktionsmed ...

MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Kirurgi

Artiklar i publikationen: Medical Devices

Av lärosätet: Uppsala universitet; Karolinska Institutet; Umeå universitet

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