EUCTR2009-016613-22-SE进行中（未招募）不适用
A double-blind, placebo controlled multi-centre study to evaluate the effects of topical Oxytocin on vaginal atrophy in postmenopausal women.
PeP-Tonic Medical AB0 个研究点目标入组 74 人开始时间: 2009年12月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Signed informed consent
- •-= 40 years of age
- •-Naturally postmenopausal women, completely without menstrual bleedings for at least 4 years prior to screening.
- •-FSH plasma levels = 40IU/L and 17-beta-estradiol levels < 70 pmol/L
- •-Vaginal pH > 5.0
- •-BMI = 29 kg/m2
- •-Vaginal atrophy verified by cytological assessment of the vaginal mucosal epithelium. Vaginal atrophy is defined as = 5% superficial cells.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effect within 3 months prior to screening
- •-Any condition that is a contraindication to treatment with sex steroids
- •-Vaginal bleeding of unknown origin
- •-Any untreated urogenital infection within 7 days prior to inclusion
- •-Any prior or concurrent malignant disease or endometrial hyperplasia
- •-Cervical cytology = CIN 1 assessed during screening
- •-Systolic Blood Pressure = 140 mmHg or diastolic Blood Pressure = 90 mmHg at screening
- •-Concurrent and diagnosed nephrologic or hepatic disorder
研究者
相似试验
进行中（未招募）
不适用
A double-blind, placebo controlled multi-centre study to evaluate the effects of topical Oxytocin on vaginal atrophy in postmenopausal women.Vaginal atrophy in postmenopausal womenMedDRA version: 12.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophyEUCTR2009-016613-22-GBPeP-Tonic Medical AB74
进行中（未招募）
不适用
A double-blind, placebo-controlled, multicentre study with an open-label extension to evaluate the efficacy and safety of tetrahydrobiopterin (BH4) in children and adolescents with hyperphenylalaninemia caused by phenylalanine hydroxylase deficiencyHyperphenylalaninemia due to phenylalanine hydroxylase deficiency. Phenotypes: classic phenylketonuria (PKU), mild PKU (MPK) or mild hyperphenylalaninemia (HPA).MedDRA version: 81Level: LLTClassification code 10034873EUCTR2006-000648-15-ATORPHANETICS Pharma Entwicklungs- GmbH75
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-EEBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - N/ASecondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-LTBioMS Technology Corp553
进行中（未招募）
不适用
A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis. - MAESTRO-01Secondary progressive multiple sclerosisMedDRA version: 8.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosisEUCTR2004-002571-16-GBBioMS Technology Corp553