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

August 28, 2023 updated by: Rajavithi Hospital

Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman: A Randomized Placebo-controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • Oxytocin vaginal gel
Placebo Comparator: Placebo gel
Placebo gel (HPMC 4,000 cps base gel) , applied at vaginal canal 1 ml per day for 8 weeks
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of vaginal cytology test for vaginal maturation index measurement
Time Frame: Change from baseline VMI at 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of vaginal health index; scoring from vaginal examination
Time Frame: Change from baseline vaginal health index score at 8 weeks
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
Time Frame: Change from baseline subjective symptom score at 2 weeks
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
Time Frame: Change from baseline subjective symptom score at 4 weeks
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
Time Frame: Change from baseline subjective symptom score at 8 weeks
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
Time Frame: Vaginal pH at 8 weeks
pH from Nitrazine paper test
Vaginal pH at 8 weeks
Comparison of adverse events between two group
Time Frame: adverse events within 8 weeks
present of adverse events
adverse events within 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

August 28, 2023

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 25, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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