A Double-blind, Placebo Controlled Single Centre Trial to Evaluate the Dose-relationship of the Effects of Vaginally Administered Oxytocin on the Vaginal Mucosal Membrane in Postmenopausal Women With Vaginal Atrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.
研究概览
简要总结
Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections . The mucosal epithelium shows signs of severe senile atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells . Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically via the posterior pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women, an effect which could be attributed either to the direct stimulation of new cell formation or to an increased production of other growth factors. The primary objective is to investigate the dose relationsship of topical administrated Vagitocin on the vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after baseline.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline.
- •> 40 years of age.
- •Moderate to severe symptoms of at least one of the following criteria of vulvar and vaginal atrophy associated with the menopause, according to the patient's self-assessement: vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or presence of vaginal bleeding associated with sexual activity.
- •Atrophic mucosa according to the investigator's assessment.
- •Signed Informed Consent.
排除标准
- •Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline.
- •Usage of any lubricant for intra-vaginal administration at baseline.
- •Vaginal bleeding of unknown origin.
- •Vaginal pH ≤ 5.
- •Any ongoing uro-genital infection within 7 days prior to baseline.
- •Body Mass Index (BMI) >30 kg/m
- •Systolic Blood Pressure > 150 mmHg and Diastolic Blood Pressure > 90 mmHg at baseline.
- •Any concurrent known or suspected tumor disease as judged by the investigator.
- •Clinically significant medical history (excluding medically well-controlled hypertension and hypercholesterolemia), abnormal findings from physical examinations, vital signs, cytology, histology, US examination of uterus and ovaries or laboratory analyses that may interfere with the trial objectives or compromise the safety of the patient as judged by the Investigator.
- •Concurrent and diagnosed nephrological or hepatic disorder
- •Diagnosed with HIV, Hepatitis B or C
- •Known or suspected drug or alcohol abuse, within 12 months prior to baseline.
- •Known or suspected allergy to any ingredient of the trial product.
- •Incapacity to perform trial procedures, as judged by the investigator.
- •Participation in any other interventional clinical trial within 3 months prior to baseline.
研究组 & 干预措施
Oxytocin 100 i.u.
N=24 patients are administrated Oxytocin 100 i.u. vaginally
干预措施: Oxytocin 100 i.u. (Drug)
Oxytocin 400 i.u.
N=24 patients are administrated Oxytocin 400 i.u. vaginally
干预措施: Oxytocin 400 i.u. (Drug)
Placebo
N=16 patients are administrated placebo vaginally
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.
时间窗: from baseline visit to 7 weeks of treatment
Change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3).
次要结局
- To investigate the safety and tolerability of topical Vagitocin treatment.(From visit 2 to visit 7)