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

NCT06514586 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: Oxagon
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Atrophy; Genitourinary Syndrome of Menopause; Vulvar Atrophy

Keywords

vulvovaginal atrophy; postmenopause; vulvovaginal; atrophy

Outcome Measures

Primary Outcomes (3)

• 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.

  60 days

• 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.

  60 days

• 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).

  60 days

Secondary Outcomes (12)

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

  Days 30 and 75

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

  Days 60 and 75

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

  Days 30, 60, and 75

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

  Days 30, 60, and 75

• The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound.

  Days 30, 60, and 75

Other Outcomes (6)

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

  Days 60 and 75

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

  Days 30, 60 and 75

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

  Day 60

Study Arms (2)

MenOxy

ACTIVE COMPARATOR

The investigational product will contain a Plastic tube containing 36 g of study product (gel) and a Vaginal calibrated plastic applicator for dose (1 ml) administration. The active constituent is oxytocin 600 IU/ml dissolved in a gel based on Hypromellose with a pH of 3.8.

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

The placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin.

Other: Hydroxypropyl methylcellulose

Interventions

Oxytocin DRUG

Oxytocin gel 600 IU . 1mg/g

MenOxy

Hydroxypropyl methylcellulose OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 47 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \> 5.0 at screening 6. A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) \> 40 milli International Units (mIU)/ml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits

You may not qualify if:

• 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.
• Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.
• Critically ill patients.
• Patients with severe renal impairment (GFR \< 30 ml/min/1.73 m2 as measured by the Cockcroft-Gault formula).
• Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.
• Patients with known or suspected allergy or any contraindications to oxytocin.

Sponsors & Collaborators

• Oxagon: lead

Study Sites (1)

Oxagon

Cairo, Egypt

Location

MeSH Terms

Conditions

Atrophy

Interventions

Oxytocin; Hypromellose Derivatives

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Cellulose; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Assem Anwar

  Azhar Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Gado

CONTACT

00201094742244; ibrahim.gado@oxagon-ab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: A Double-Blinded Randomized Controlled Trial The study includes 2 arms. The subjects will be randomized to receive (apply) either oxytocin topical gel (intervention arm) or placebo gel (control arm).

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: July 23, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

EG (1)