A double-blind, placebo controlled multi-centre study to evaluate the effects of topical Oxytocin on vaginal atrophy in postmenopausal women.
- Conditions
- Vaginal atrophy in postmenopausal womenMedDRA version: 12.1Level: LLTClassification code 10047782Term: Vulvovaginal atrophy
- Registration Number
- EUCTR2009-016613-22-GB
- Lead Sponsor
- PeP-Tonic Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 74
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method