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The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy

ConditionsVaginal AtrophyGenitourinary Syndrome of MenopauseVulvar Atrophy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age47-65
SponsorOxagon

About this trial

A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.

Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and/or dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.

Disqualifiers

Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.

Women taking systemic hormone replacement or pills within the last 6 months.

Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding

Any untreated urogenital infection within 14 days prior to randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxytocin

    Drug

    Oxytocin gel 600 IU . 1mg/g

  • Hydroxypropyl methylcellulose

    Other intervention

    Placebo

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: MenOxyActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.

MBS is a moderate to severe symptom identified as the most bothersome by the subject at baseline, recorded as none, mild, moderate, or severe was analyzed using the score values of 0, 1, 2, or 3, respectively. Symptoms include vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain (dyspareunia), or bleeding associated with sexual activity.

Time frame
60 days
2

The mean change from the baseline to Day 60 of the vaginal pH

Vaginal pH as measured by a pH strip applied directly to the lateral wall of the vagina, recording the pH value (to one decimal) according to the comparison to the color chart.

Time frame
60 days
3

The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)

VMI is calculated using the Meisels'(Meisels, 1967) formula: (0 \* Parabasal Cells) + (0.5 \* Intermediate Cells) + (1 \* Superficial Cells).

Time frame
60 days

Secondary outcomes

1

The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75

Time frame
Days 30 and 75
2

The percentage of subjects identified as Responders on days 60 and 75.

A responder is a subject meeting all the following criteria: at least 1 point improvement (decrease) in the severity of the MBS, at least a 0.5-point decrease in the vaginal pH, and at least 20% improvement in the VMI.

Time frame
Days 60 and 75
3

The mean change from the baseline to Days 30, 60, and 75 of the physical examination of the vulva and vagina

Assessment of the physical signs of VA (Vaginal secretions, Vaginal Epithelial Integrity, Vaginal Epithelial Surface Thickness, and Vaginal Color) as evaluated by the physician/gynecologist and corresponding to none, mild, moderate, or severe atrophy and analyzed using the score values of 0, 1, 2, and 3, respectively.

Time frame
Days 30, 60, and 75
4

The mean changes from the baseline to Days 30, 60, and 75 in Vaginal Wall Thickness as measured by transvaginal ultrasound.

Time frame
Days 30, 60, and 75

Other outcomes

1

The mean change in weight from baseline to days 60 and 75, and BMI from baseline to day 75.

Time frame
Days 60 and 75
2

The number of subjects reporting changes in appetite (satiety/hunger) on days 30, 60, and 75.

Time frame
Days 30, 60 and 75
3

The mean change in fasting blood glucose, HbA1C, and insulin levels from baseline to days 60.

Time frame
Day 60
4

The mean change in blood pressure from baseline to days 30, 60, and 75.

Time frame
Days 30, 60 and 75

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oxagon

Lead sponsor

Source ClinicalTrials.gov

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