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Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.
Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria. All women provided written informed consent before data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin gel | Experimental | Oxytocin gel 400IU per 1 ml (on HPMC 4,000 cps base gel), applied at vaginal canal 1 ml per day for 8 weeks |
|
| Placebo gel | Placebo Comparator | Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Oxytocin vaginal gel that have oxytocin 400IU/1ml of gel, base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of vaginal cytology test for vaginal maturation index measurement | VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy | Change from baseline VMI at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of vaginal health index; scoring from vaginal examination | Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination | Change from baseline vaginal health index score at 8 weeks |
| Comparison of subjective symptoms by The most bothersome symptoms score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32429977 | Background | Zohrabi I, Abedi P, Ansari S, Maraghi E, Shakiba Maram N, Houshmand G. The effect of oxytocin vaginal gel on vaginal atrophy in postmenopausal women: a randomized controlled trial. BMC Womens Health. 2020 May 19;20(1):108. doi: 10.1186/s12905-020-00935-5. | |
| 31547180 | Background | Alvisi S, Gava G, Orsili I, Giacomelli G, Baldassarre M, Seracchioli R, Meriggiola MC. Vaginal Health in Menopausal Women. Medicina (Kaunas). 2019 Sep 20;55(10):615. doi: 10.3390/medicina55100615. |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Placebo | Drug | Placebo gel that have base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 without oxytocin |
|
score from 0-4, 0 = absent, 4 = severe symptom |
| Change from baseline subjective symptom score at 2 weeks |
| Comparison of subjective symptoms by The most bothersome symptoms score | score from 0-4, 0 = absent, 4 = severe symptom | Change from baseline subjective symptom score at 4 weeks |
| Comparison of subjective symptoms by The most bothersome symptoms score | score from 0-4, 0 = absent, 4 = severe symptom | Change from baseline subjective symptom score at 8 weeks |
| Comparison of vaginal pH between two group | pH from Nitrazine paper test | Vaginal pH at 8 weeks |
| Comparison of adverse events between two group | present of adverse events | adverse events within 8 weeks |
| 27472999 | Background | Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26. |
| 22120944 | Background | Jonasson AF, Edwall L, Uvnas-Moberg K. Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study. Menopause Int. 2011 Dec;17(4):120-5. doi: 10.1258/mi.2011.011030. Epub 2011 Nov 25. |
| 33116956 | Background | Fianu Jonasson A, Bixo M, Sundstrom Poromaa I, Astrom M. Safety and Efficacy of an Oxytocin Gel and an Equivalent Gel but Without Hormonal Ingredients (Vagivital(R) Gel) in Postmenopausal Women with Symptoms of Vulvovaginal Atrophy: A Randomized, Double-Blind Controlled Study. Med Devices (Auckl). 2020 Oct 5;13:339-347. doi: 10.2147/MDER.S265824. eCollection 2020. |
| 28381099 | Background | Kallak TK, Uvnas-Moberg K. Oxytocin stimulates cell proliferation in vaginal cell line Vk2E6E7. Post Reprod Health. 2017 Mar;23(1):6-12. doi: 10.1177/2053369117693148. Epub 2017 Mar 8. |
| 18427354 | Background | Hess R, Austin RM, Dillon S, Chang CC, Ness RB. Vaginal maturation index self-sample collection in mid-life women: acceptability and correlation with physician-collected samples. Menopause. 2008 Jul-Aug;15(4 Pt 1):726-9. doi: 10.1097/gme.0b013e31816c5541. |
| 29347848 | Background | Torky HA, Taha A, Marie H, El-Desouky E, Raslan O, Moussa AA, Ahmad AM, Abo-Louz A, Zaki S, Fares T, Eesa A. Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial. Climacteric. 2018 Apr;21(2):174-178. doi: 10.1080/13697137.2017.1421924. Epub 2018 Jan 19. |
| 25995333 | Background | Al-Saqi SH, Uvnas-Moberg K, Jonasson AF. Intravaginally applied oxytocin improves post-menopausal vaginal atrophy. Post Reprod Health. 2015 Sep;21(3):88-97. doi: 10.1177/2053369115577328. Epub 2015 May 19. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |