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

Sponsor

Rajavithi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05627791

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Atrophy Oxytocin Gel Postmenopausal Women Vaginal Maturation Index	Drug: Oxytocin Drug: Placebo	Phase 2/Phase 3

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.

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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of vaginal cytology test for vaginal maturation index measurement [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

Secondary Outcome Measures

Comparison of vaginal health index; scoring from vaginal examination [Change from baseline vaginal health index score at 8 weeks]
Score 5-25, below 15 mean significant vulvovaginal atrophy from physical examination
Comparison of subjective symptoms by The most bothersome symptoms score [Change from baseline subjective symptom score at 2 weeks]
score from 0-4, 0 = absent, 4 = severe symptom
Comparison of subjective symptoms by The most bothersome symptoms score [Change from baseline subjective symptom score at 4 weeks]
score from 0-4, 0 = absent, 4 = severe symptom
Comparison of subjective symptoms by The most bothersome symptoms score [Change from baseline subjective symptom score at 8 weeks]
score from 0-4, 0 = absent, 4 = severe symptom
Comparison of vaginal pH between two group [Vaginal pH at 8 weeks]
pH from Nitrazine paper test
Comparison of adverse events between two group [adverse events within 8 weeks]
present of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rajavithi Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rajavithi Hospital

ClinicalTrials.gov Identifier:

NCT05627791

Other Study ID Numbers:

65065

First Posted:

Nov 28, 2022

Last Update Posted:

Nov 28, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrophy

Oxytocin

Study Results

No Results Posted as of Nov 28, 2022