The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial

Ilnaz Zohrabi, Parvin Abedi, Somayeh Ansari, Elham Maraghi, Nader Shakiba Maram, Gholamreza Houshmand, Ilnaz Zohrabi, Parvin Abedi, Somayeh Ansari, Elham Maraghi, Nader Shakiba Maram, Gholamreza Houshmand

Abstract

Background: Around 90% of postmenopausal women are suffering from vaginal atrophy. This study aimed to evaluate the effect of oxytocin vaginal gel on vaginal atrophy among postmenopausal women.

Methods: This was a randomized controlled trial that was conducted on 96 postmenopausal women who suffered from vaginal atrophy. The inclusion criteria were: literate women, age 40-60, at least 1 year passed from their last menstrual period or the level of FSH > 40 IU, monogamous women with the sexual relationship. Women in the intervention group, requested to use one applicator of 400 IU oxytocin gel per night and women in the placebo group used placebo each night. The subjective symptoms of vaginal atrophy, vaginal PH, maturation index were measured before and after the intervention.

Results: The number of superficial cells was increased significantly in the oxytocin group compared to placebo (38.7 ± 7.18 vs. 3.69 ± 2.76, p = 0.0001), while the number of parabasal cells was decreased significantly in the oxytocin compared to placebo after the intervention. The improvement of the maturation index was more dominant in the oxytocin group (increased from 7.76 ± 4.68 to 52.48 ± 7.54) in comparison to the placebo group (increased from 8.58 ± 4.35 to 13.25 ± 5.06). The PH of the vagina decreased significantly in the oxytocin group in comparison to the placebo group (p = 0.0001). After 8 weeks, 88.6 and 7.1% of women in the oxytocin and placebo groups did not show the severe symptoms of vaginal atrophy (p = 0.001).

Conclusion: The results of this study showed that eight- week intervention with oxytocin vaginal gel (400 IU) could significantly improve the vaginal maturation index, subjective symptoms of vaginal atrophy and reduce the PH of the vagina. Using this medication in women who have a contraindication for hormone therapy is recommended.

Trial registration: IRCT20160602028220N2.

Keywords: Oxytocin; Postmenopausal women; Vaginal atrophy.

Conflict of interest statement

Parvin Abedi is an associate editor of BMC Pregnancy and Childbirth and other than this; the authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of recruitment and retention of participants in the study

References

    1. Palacios S, Nappi RE, Bruyniks N, et al. The European vulvovaginal epidemiological survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause. Climacteric. 2018;21(3):286–291. doi: 10.1080/13697137.2018.1446930.
    1. Castelo-Branco C, Rostro F. Treatment of atrophic vaginitis. Therapy. 2007;4(3):349–353. doi: 10.2217/14750708.4.3.349.
    1. Castelo-Branco C, Cancelo MJ. Compounds for the treatment of atropic vaginitis. Expert Opin Ther Pat. 2008;18(12):1385–1394. doi: 10.1517/13543770802564464.
    1. Sturdee DW, Panay N. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric. 2010;13(6):509–522. doi: 10.3109/13697137.2010.522875.
    1. Noumova I, Castelo-Branco C. Current treatment options for postmenopausal vaginal atrophy. Int J Women's Health. 2018;10:387–395. doi: 10.2147/IJWH.S158913.
    1. Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition? Climacteric. 2016;19(2):151–161. doi: 10.3109/13697137.2015.1124259.
    1. North American Menopause Society The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of the North American Menopause Society. Menopause. 2007;14(3 Pt 1):355–369.
    1. U.S Department of Health and Human services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Guidance for industry estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms-recommendations for clinical evaluation. 2003.
    1. Wentzensen Nicolas, Trabert Britton. Hormone therapy: short-term relief, long-term consequences. The Lancet. 2015;385(9980):1806–1808. doi: 10.1016/S0140-6736(14)62458-2.
    1. Ibe C, Simon JA. Vulvovaginal atrophy: current and future therapies. J Sex Med. 2010;7:1042–1050. doi: 10.1111/j.1743-6109.2009.01692.x.
    1. Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: a double-blind randomized placebo-controlled trial. Maturitas. 2016;84:75–80. doi: 10.1016/j.maturitas.2015.11.005.
    1. Emamverdikhan AP, Golmakani N, Tabbasi SA, Hassanzadeh M, Sharifi N, Shakeri MT. A survey of the therapeutic effects of vitamin E suppositories on vaginal atrophy in postmenopausal women. Iran J Nurs Midwifery Res. 2016;21(5):475–481. doi: 10.4103/1735-9066.193393.
    1. Rad P, Tadayon M, Abbaspour M, Latifi SM, Rashidi I, Delaviz H. The effect of vitamin D on vaginal atrophy in postmenopausal women. Iran J Nurs Midwifery Res. 2015;20(2):211–215.
    1. Ludwig M, Leng G. Dendritic peptide release and peptide-dependent behaviours. Nat Rev Neurosci. 2006;7:126–136. doi: 10.1038/nrn1845.
    1. Uvnäs-Moberg K, Petersson M. Oxytocin, a mediator of anti-stress, well-being, social interaction, growth and healing. Z Psychosom Med Psychother. 2005;51:57–80.
    1. Blaicher W, Gruber D, Bieglmayer C, Blaicher AM, Knogler W, Huber JC. The role of oxytocin in relation to female sexual arousal. Gynecol Obstet Investig. 1999;47(2):125–126. doi: 10.1159/000010075.
    1. Al-Saqi SH, Uvnäs-Moberg K, Jonasson AF. Intravaginally applied oxytocin improves post-menopausal vaginal atrophy. Post Reprod Health. 2015;21(3):88–97. doi: 10.1177/2053369115577328.
    1. Torky HA, Taha A, Marie H, El-Desouky E, Raslan O, Moussa AA, et al. Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial. Climacteric. 2018;21(2):174–178. doi: 10.1080/13697137.2017.
    1. Buckley SJ. Executive summary of hormonal physiology of childbearing: evidence and implications for women, babies, and maternity care. J Perinat Educ. 2015;24(3):145–153. doi: 10.1891/1058-1243.24.3.145.
    1. Roshangar L, Soleimani Rad J, Nikpoo P, Sayyah Melli M. Effect of oxytocin injection on folliculogenesis, ovulation and endometrial growth in mice. Iranian J Reprod Med. 2009;7(2):91–95.
    1. Al-Eknah MM, Homeida A, Galil AKA, Elbashi AE. Oxytocin-induced biochemical changes in cervical mucus of the goat. Theriogenology. 1991;36(1):143–148. doi: 10.1016/0093-691X(91)90443-H.
    1. Gutkowska J, Jankowski M, Mukaddam-Daher S, et al. Oxytocin is a cardiovascular hormone. Braz J Med Biol Res. 2000;33:625–633. doi: 10.1590/S0100-879X2000000600003.
    1. Petersson M, Lundeberg T, Sohlstrom A, et al. Oxytocin increases the survival of musculocutaneous flaps. Naunyn Schmiedeberg's Arch Pharmacol. 1998;357:701–714. doi: 10.1007/PL00005227.
    1. Roshangar L, Soleimani Rad J, Nikpoo P, Sayyah Melli M. Effect of oxytocin injection on folliculogenesis, ovulation and endometrial growth in mice. IJRM. 2009;7(2):91.
    1. Jonasson A. F., Edwall L., Uvnas-Moberg K. Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study. Menopause International. 2011;17(4):120–125. doi: 10.1258/mi.2011.011030.
    1. Ahmed M, Yenzeel J, Majeed A. Bacterial study of vagina in Awassi ewes treated with prostaglandin (PGF2 α) and oxytocin. Al-Anbar J Vet Sci. 2017;10(1):96–98.

Source: PubMed

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