A pharmacokinetic study of vaginally and intravenously administered oxytocin in postmenopausal women with vaginal atrophy

PeP-Tonic Medical AB0 个研究点开始时间: 2013年6月24日最近更新: 2014年8月28日

试验速览

暂无简介。

•- Subjects who are postmenopausal women with vaginal atrophy as judged by the investigator
•- Subjects who are willing to participate in the study as indicated by signing the informed
•- Subjects who are healthy post-menopausal women between the ages of 40 and 70 years, inclusive
•- Subjects who have body mass index (BMI) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2
•- Subjects who are judged by the Investigator to be healthy on the basis of medical evaluation
•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 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•- Hospitalized subjects
•- Subject who have symptoms of any significant acute illnesses at the screening visit
•- Subjects who have a history of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product)
•- Subjects who have a known history of sensitivity to oxytocin or related derivatives
•- Subjects with FSH level < 40 pmol/mL
•- Subjects who have a known history of narcotic addiction, drug abuse or alcoholism
•- Subjects who simultaneously participate in another clinical study
•- Subjects who use any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline
•- Subjects who have uncontrolled hypertension and/or hypercholesterolemia

发起方

PeP-Tonic Medical AB