Providing evidence of the effectiveness of megestrol and medroxyprogesterone on the quality of life of menopausal women
Design
A randomized, two-group clinical trial, triple-blind, phase 3, will be conducted on 80 patients. The web-based software https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for randomization.
Settings and conduct
A total of 80 menopausal women who meet the inclusion criteria will be recruited as research participants from Kamali Hospital in Karaj. The participants will enter the study using convenience and consecutive sampling methods. They will be randomly assigned using block randomization into one of two groups: the treatment group receiving the desired treatment (oral 40mg Megestrol) and the control group receiving the standard medication (oral 10mg Medroxyprogesterone). To ensure concealment, non-homogeneous block sizes will be used. The study will be conducted in a triple-blind manner, where the data analyst will not be aware of the allocation group. The data related to the received treatment will be entered into the SPSS software as Groups 1 and 2. The outcome assessor will also be blinded to the allocation group. To maintain blinding among participants, identical containers will be provided for medication delivery.
Participants/Inclusion and exclusion criteria
Iranian women aged 45 to 55 year.
FSH serum level greater than or equal to 40-20 mm units per milliliter (pre menopausal)
Do not have a physical or mental illness .
Do not have addiction or use of hookah cigarettes or alcohol.
The person's body mass index should be less than or equal to 29.
Intervention groups
Intervention group 1: recipients of Megestrol 40 one daily
Intervention group 2: recipients of Medroxyprogesterone 10 every 12 hours
Main outcome variables
The results include improvement in vasomotor, physical, psychosocial and sexual areas.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230930059567N1
Registration date:2023-11-11, 1402/08/20
Registration timing:prospective
Last update:2023-11-11, 1402/08/20
Update count:0
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
Seyede Bahareh Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3256 5782
Email address
hbahareh53@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low dose Megestrol (40 mg) and Medroxyprogesterone 10 mg on the quality of life in menopausal women.
Public title
Comparison of the effect of low dose Megestrol (40 mg) and Medroxyprogesterone 10 mg on the quality of life in menopausal women.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian women aged 45 to 55 year.
FSH serum level greater than or equal to 40-20 mm units per milliliter (pre menopausal)
Do not have a physical or mental illness .
Do not have addiction or use of hookah cigarettes or alcohol.
The person's body mass index should be less than or equal to 29.
Exclusion criteria:
Age
From 45 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
1. Randomization method: Blocked
2. Randomization unit: Individual
3. Randomization Tool : A randomization list is generated using a web-based software (https://www.sealedenvelope.com/simple-randomiser/v1/lists), which is only accessible to a researcher who is not involved in assigning or evaluating the outcomes. At the time of identifying each sample, the allocation group of the patient is announced according to the list through this researcher.
4. Method of generating the random sequence: A randomization list is prepared using a web-based software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The block sizes of 2, 4, and 6 are considered.
5. Explanation of allocation concealment: By considering non-homogeneous block sizes, the allocation sequence will be concealed. In addition, a randomization list is generated, which is only available to a researcher who is not involved in assigning or evaluating the outcomes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is conducted in a triple-blind manner. In this type of blinding, the data analyst will not be aware of the treatment group allocation. The data related to the received treatment will be entered into the SPSS software as groups 1 and 2. The outcome assessor will also be unaware of the treatment group allocation. To blind the participants, medications will be given to patients in similar containers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences , Administrative Town , North Taleghani Blvd , Taleghani Square, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
IR.ABZUMS.REC.1402.114
Health conditions studied
1
Description of health condition studied
Menopause symptoms
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Quality of life score in menqol questionnaire
Timepoint
Measuring the quality of life during the study and 1 month after Megestrol consumption
Method of measurement
Menopausal Women's Quality of Life Questionnaire - Persian version (Menqol)
2
Description
Quality of life score in menqol questionnaire
Timepoint
Measuring the quality of life during the study and 1 month after Medroxyprogestrone consumption.
Method of measurement
Menopausal Women's Quality of Life Questionnaire - Persian version (Menqol)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Megestrol Acetate, C24H32O4, 40 milligrams, one tablet per day, for one month, accompanied by a glass of water.
Category
Other
2
Description
Intervention group : Medroxyprogesterone Acetate, C22H32O3, 10 milligrams, one tablet every 12 hours for one month, accompanied by a glass of water.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Seyede Bahareh Hosseini
Street address
Alborz University of Medical Sciences , Administrative Town, North Taleghani Blvd , Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Alborz University Of Medical Sciences
Street address
Alborz University of Medical Sciences , Administrative Town, North Taleghani Blvd , Taleghani Square,Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
Info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Samira Abdollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alborz University of Medical Sciences, Administrative Town, North Taleghani Blvd , Taleghani Square, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
samiraabdollahi66@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Samira Abdollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alborz University of Medical Sciences, Administrative Town, North Taleghani Blvd, Taleghani Square, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
samiraabdollahi66@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Seyede Bahareh Hosseini
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alborz University of Medical Sciences, Administrative Town, North Taleghani Blvd,Taleghani Square, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Fax
Email
hbahareh53@gmail.com
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