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Trial · Interventional

TerminatedPhase 2/3Registry data

Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

NCTNCT05627791 (opens ClinicalTrials.gov in a new tab)Other id65065
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2/3
Enrollment
6 participants (actual)
Sponsor
Department of Medical Services Ministry of Public Health of Thailand · Other gov
Design
Randomized · Quadruple masking
Countries
1 country

Thailand

Start
30 Nov 2022
Primary completion
31 Jul 2023
Completion
28 Aug 2023
First posted
28 Nov 2022
Last update posted
31 Aug 2023
Conditions
Vaginal Atrophy · Oxytocin Gel · Postmenopausal Women · Vaginal Maturation Index

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 2/3

    Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

    NCT05627791

    30 Nov 2022 to 28 Aug 2023

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin gel

    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 comparator

    Placebo gel

    Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Comparison of vaginal cytology test for vaginal maturation index measurement

    Time frame · Change from baseline VMI at 8 weeks

    Registry description

    VMI = 0.2 × % parabasal cells+0.6 × % intermediate cells+1.0 × % superficial cells score below 52 mean significant vulvovaginal atrophy

Secondary outcomes(6)

  1. Comparison of vaginal health index; scoring from vaginal examination

    Time frame · Change from baseline vaginal health index score at 8 weeks

    Registry description

    Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination

  2. Comparison of subjective symptoms by The most bothersome symptoms score

    Time frame · Change from baseline subjective symptom score at 2 weeks

    Registry description

    score from 0-4, 0 = absent, 4 = severe symptom

  3. Comparison of subjective symptoms by The most bothersome symptoms score

    Time frame · Change from baseline subjective symptom score at 4 weeks

    Registry description

    score from 0-4, 0 = absent, 4 = severe symptom

  4. Comparison of subjective symptoms by The most bothersome symptoms score

    Time frame · Change from baseline subjective symptom score at 8 weeks

    Registry description

    score from 0-4, 0 = absent, 4 = severe symptom

  5. Comparison of vaginal pH between two group

    Time frame · Vaginal pH at 8 weeks

    Registry description

    pH from Nitrazine paper test

  6. Comparison of adverse events between two group

    Time frame · adverse events within 8 weeks

    Registry description

    present of adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2020

5 results

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

Zohrabi et al. 2020BMC women's healthcited by 12

PMID 32429977PMC7236919DOI 10.1186/s12905-020-00935-5PUB-32429977

CC BY5 results
Download PDFSee results (5)

Indexing hint: Randomized controlled trial · 2015

6 results

Intravaginally applied oxytocin improves post-menopausal vaginal atrophy.

Al-Saqi et al. 2015Post reproductive healthcited by 31

PMID 25995333PMC4566058DOI 10.1177/2053369115577328PUB-25995333

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2011

6 results

Topical oxytocin reverses vaginal atrophy in postmenopausal women: a double-blind randomized pilot study.

Jonasson et al. 2011Menopause internationalcited by 30

PMID 22120944DOI 10.1258/mi.2011.011030PUB-22120944

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

4 studies on this page

PubMed tag: none · 2020

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.

Fianu Jonasson et al. 2020Medical devices (Auckland, N.Z.)cited by 5

PMID 33116956PMC7547122DOI 10.2147/mder.s265824PUB-33116956

Free to read · publisher termsCC BY-NC
Read at source
Retracted· published 19 Jan 2018This study is retracted. Read the notice first. Its results never count as key results.

Indexing hint: Randomized controlled trial · 2018

Role of topical oxytocin in improving vaginal atrophy in postmenopausal women: a randomized, controlled trial.

Torky et al. 2018Climacteric : the journal of the International Menopause Societycited by 15

PMID 29347848DOI 10.1080/13697137.2017.1421924PUB-29347848

Full text at the publisher
Read the noticePublisher page

PubMed tag: none · 2017

Oxytocin stimulates cell proliferation in vaginal cell line Vk2E6E7.

Kallak et al. 2017Post reproductive healthcited by 17

PMID 28381099DOI 10.1177/2053369117693148PUB-28381099

Full text at the publisher
Publisher page

Indexing hint: Review · 2016

Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management.

Gandhi et al. 2016American journal of obstetrics and gynecologycited by 262

PMID 27472999DOI 10.1016/j.ajog.2016.07.045PUB-27472999

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language. Exclusion Criteria: * Have acute vulvovaginitis (vaginal swab for wet smear and KOH) * Patients who have used hormonal replacement therapy within 12 months * Patients with a history of smoking * Patients who have used vaginal lubricant or moisturizer * Patients with an allergic history of oxytocin or gel components * Morbid obesity BMI \> 30 kg/m2 * Patients who have used vitamin E supplement * Patients who unable to perform per vaginal examination

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