Clinical trial

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

Name

65065

Description

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.

Trial arms

Trial start

2022-11-30

Estimated PCD

2023-07-31

Trial end

2023-08-28

Status

Terminated

Phase

Early phase I

Treatment

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

Arms:

Oxytocin gel

Other names:

Oxytocin vaginal gel

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

Arms:

Placebo gel

Size

Primary endpoint

Comparison of vaginal cytology test for vaginal maturation index measurement

Change from baseline VMI at 8 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

Updated at

2023-08-31

1 organization

1 product

1 drug

4 indications

Organization

Rajavithi Hospital

Product

Oxytocin

Indication

Atrophic vaginitis