The goal of this study is to assess the effects of Foeniculum vulgare on vaginal atrophy and sexual function. Inclusion criteria were: postmenopausal status, which was defined as aged between 45-65 with no vaginal bleeding for 1 year; no regular ingestion of phytoestrogen or soy-based products; having a normal mammogram in the last year; vaginal infection; smoking; Currently (or in the past 6 months) using estrogen ; no regular physical exercise or allergy to Foeniculum vulgare. In a double-blind, randomized, placebo-controlled trial, 60 postmenopausal women recruiting in Imam Reza Hospital in Mashhad were randomized to fennel (n=30) and placebo group (n=30) using random table. Maturation Index and martial satisfaction were measured at baseline and after three months. Also, placebos and fennel capsules were identical in terms of shape and size
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091628789N2
Registration date:2016-11-11, 1395/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-11, 1395/08/21
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 4230 9487
Email address
ghazanfarpm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad
Expected recruitment start date
2014-05-12, 1393/02/22
Expected recruitment end date
2016-05-22, 1395/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy Foeniculum vulgare and placebo on atrophy vaginal and sexual function in postmenopausal women
Public title
the effect of fennel on vaginal dryness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: postmenopausal status, which was defined as aged between 45-65 with no vaginal bleeding for 1 year; no regular ingestion of phytoestrogen or soy-based products; having a normal mammogram in the last year; vaginal infection; smoking; Currently (or in the past 6 months) using estrogen ; no regular physical exercise; allergy to Foeniculum vulgare
Age
From 44 years old to 64 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Biomedical research, Mashhad University of Medical Sciences