Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with non atypical endometrial hyperplasia under treatment with medroxyprogesterone.
-
Design
-
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive supplements (n=50) or placebo (n=50).
-
Settings and conduct
-
Among premenopausal women with non atypical endometrial hyperplasia who are referred to Shahid Beheshti Gynecology Clinic affiliated to Kashan University of Medical Sciences, 100 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar. Fasting blood samples will be taken at baseline and 3 months after the intervention. intervention period: 3 months.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Women aged 30 to 45 years who are diagnosed with non atypical endometrial hyperplasia. Exclusion criteria: Those taking any hormonal medicine within 6 months prior to enrollment in the study, patients with focal endometrial lesions, atypical endometrial hyperplasia, women with congenital uterine anomalies, and menopause women, Hypersensitivity to soybean products, Unwillingness to cooperate.
-
Intervention groups
-
Intervention group: Isoflavone 50 mg Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months. Control group: Placebo Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months.
-
Main outcome variables
-
Endometrial histology is the primary outcome and Serum estradiol levels and drug side effects are secondary outcomes in this trial.
General information
-
Reason for update
-
The updating process was done before publishing the paper to correct the registration information.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200531047614N3
Registration date:
2021-01-20, 1399/11/01
Registration timing:
registered_while_recruiting
Last update:
2022-06-05, 1401/03/15
Update count:
1
-
Registration date
-
2021-01-20, 1399/11/01
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-05-21, 1399/03/01
-
Expected recruitment end date
-
2021-07-29, 1400/05/07
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effects of isoflavone supplementation compared with placebo on endometrial histology and serum estradiol levels in premenopausal women with non atypical endometrial hyperplasia
-
Public title
-
The effects of isoflavone supplementation in the treatment of non atypical endometrial hyperplasia
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Women aged 30 to 45 years who are diagnosed with non atypical endometrial hyperplasia
Exclusion criteria:
Those taking any hormonal medicine within 6 months prior to enrollment in the study
Patients with focal endometrial lesions
atypical endometrial hyperplasia
Women with congenital uterine anomalies
Menopause women
Hypersensitivity to soybean products.
Unwillingness to cooperate.
-
Age
-
From 30 years old to 45 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 100 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Gynecology Clinic of Shahid Beheshti Hospital, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-05-11, 1399/02/22
-
Ethics committee reference number
-
IR.KAUMS.MEDNT.REC.1399.006
Health conditions studied
1
-
Description of health condition studied
-
Non atypical endometrial hyperplasia
-
ICD-10 code
-
N85.0
-
ICD-10 code description
-
Endometrial hyperplasia
Primary outcomes
1
-
Description
-
Endometrial histology
-
Timepoint
-
At the beginning of the study and after 3 months of intervention
-
Method of measurement
-
Biopsy
Secondary outcomes
1
-
Description
-
Serum estradiol levels
-
Timepoint
-
At the beginning of the study and after 3 months of intervention
-
Method of measurement
-
Elisa
2
-
Description
-
Drug side-effects
-
Timepoint
-
At the beginning of the study and after 3 months of intervention
-
Method of measurement
-
questionnaire
Intervention groups
1
-
Description
-
Intervention group: Isoflavone 50 mg Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo Tablet (Goldaru Pharmaceutical Company, Tehran, Iran), orally, once a day, for 3 months.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available