Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05627791
Status:
TERMINATED
Last Update Posted:
2023-08-31
First Post:
2022-11-09
Brief Title:
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman
Sponsor:
Rajavithi Hospital
Organization:
Rajavithi Hospital
Study Overview
Official Title:
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman A Randomized Placebo-controlled Trial
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recuit participant number in time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
1 st Visit The vagina was assessed regarding infection and any abnormal discharge The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score The subjective symptoms were assessed by The most bothersome score The vaginal pH was tested with a Nitrazine paper The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation VMI The participants were separated into two groups 1 Oxytocin gel group and 2 Placebo gel group then applied gel 1 ml 400IU of oxytocin in oxytocin gel per day for 8 weeks consecutively The subjective symptoms were assessed at 2 and 4 weeks by phone
2 nd Visit The participants were assessed the same as 1st visit that recorded vaginal health index score subjective symptoms vaginal pH and vaginal maturation index evaluation
1 st Visit The vagina was assessed regarding infection and any abnormal discharge The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score The subjective symptoms were assessed by The most bothersome score The vaginal pH was tested with a Nitrazine paper The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation VMI The participants were separated into two groups 1 Oxytocin gel group and 2 Placebo gel group then applied gel 1 ml 400IU of oxytocin in oxytocin gel per day for 8 weeks consecutively The subjective symptoms were assessed at 2 and 4 weeks by phone
2 nd Visit The participants were assessed the same as 1st visit that recorded vaginal health index score subjective symptoms vaginal pH and vaginal maturation index evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None