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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05627791
Other study ID # 65065
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date November 30, 2022
Est. completion date August 28, 2023

Study information

Verified date August 2023
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
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
Placebo
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

Locations

Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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 2 weeks
Secondary 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
Secondary 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
Secondary Comparison of vaginal pH between two group pH from Nitrazine paper test Vaginal pH at 8 weeks
Secondary Comparison of adverse events between two group present of adverse events adverse events within 8 weeks
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