Clinical TrialID 6874

Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients

NCT01370551

Atrophic Vaginitis

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
6874
Evidence Id
6874
Core Evidence Id
6874
Source Clinical Trial Id
6866
Herb2 Clinical Trial Id
HBCT006866
Nct Id
NCT01370551
Title
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Status
Completed
Phase
Phase 1
Study Result
No
Study Condition
Atrophic Vaginitis
Study Type
Interventional
Study Design
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Intervention
DRUG: Gynoflor
Intervention Allocation
Intervention Model
Single_Group
Intervention Mask
Intervention Purpose
Treatment
Gender
Female
Age
Adult, Older_Adult
Enrollment
16
Outcome Measure
Serum concentrations of estriol (E3), estradiol (E2), estrone (E1), -0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 1 and 28|Calculation of pharmacokinetic parameters: AUC0-24, intraindividual mean, Cmax and tmax, on days 1 and 28
Sponsor Collaborator
Medinova AG
Funded By
INDUSTRY
Location
University Hospital Leuven, Leuven, Belgium|Department of Obstetrics and Gynaecology, University of Regensburg, Regensburg, Germany
Other Id
806109
Start Date
2011-04
Primary Completion Date
2012-07
Completion Date
2012-07
First Posted
2011-06-10
Results First Posted
Last Update Posted
2012-08-22
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01370551
Title Cn
Title En
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Bilingual Status
semi_complete