The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Oxagon
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)
研究概览
简要总结
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.
详细描述
A Phase three randomized, double-blinded, placebo- controlled study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. This study shall include 242 subjects. After screening , subject who meet eligibility criterial will be randomized in a 1:1 ratio to receive wither study intervention or placebo to be applied once daily for sixty days and followed up extra fifteen days. objectives is to evaluate the efficacy and effectiveness of topical oxytocin gel compared with placebo in improving postmenopausal vaginal atrophy symptoms in women with GSM , also assessing the safety and tolerability of topical oxytocin gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 47 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.)
- •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
- •Vaginal pH > 5.0 at screening
- •A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) > 40 milli International Units (mIU)/ml at screening
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
MenOxy
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.
干预措施: Oxytocin (Drug)
Placebo
The placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin.
干预措施: Hydroxypropyl methylcellulose (Other)
结局指标
主要结局
The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)
时间窗: 60 days
VMI is calculated using the Meisels'(Meisels, 1967) formula: (0 \* Parabasal Cells) + (0.5 \* Intermediate Cells) + (1 \* Superficial Cells).
The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.
时间窗: 60 days
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.
The mean change from the baseline to Day 60 of the vaginal pH
时间窗: 60 days
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.
次要结局
- The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75(Days 30 and 75)
- The mean medication incompliance rate (%) will be calculated in Days 30, and 60 for each subject as [(Total number of missed doses) / (Expected number of applications)] *100%.(Days 30,and 60)
- The incidence of AEs reported by the subjects, summarized by system organ class, severity, and relationship to study intervention, over the course of treatment.(Days 30, 60 and 75)
- The mean change from the baseline to Days 60 and 75 in selected items from the Female Sexual Function Index (FSFI).(Days 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 number and percentage of subjects on Days 30, 60, and 75 reporting Treatment-Emergent Adverse Event (TEAE), defined as any AE that occurs on or after the application of the first dose of the study intervention.(Days 30, 60 and 75)
- The rate of abnormal findings on Days 30, 60, and 75 of the transvaginal ultrasound for women with an intact uterus only.(Days 30, 60 and 75)
- The percentage of subjects identified as Responders on days 60 and 75.(Days 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)
- The rate of abnormal findings on Days 30, 60, and 75 during the physical, gynecological, and breast examinations.(Days 30, 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 change from the baseline to Days 60 and 75 in patient-reported psychometric outcomes.(Days 60 and 75)