Comparison of the effects of medroxyprogestron 10 mg and megestrol 40 mg on vasomotor symptom in menopause women
Design
This study was designed as a triple-blinded randomized clinical trial with parallel groups and a sample size of 40 people in each group
Settings and conduct
The study will be conducted at Kamali Hospital on Menopausal women Patients who signed informed consent will be randomly divided into two groups. The first group will receive Magestrol tablets 40 mg daily for 1 month and the second group will receive medroxyprogesterone 10 mg daily for one month The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process.
Participants/Inclusion and exclusion criteria
Exclusion criteria: Regular exercise program Vegetarian diet Consume soy and its products more than once a week Current use of drugs that affect hot flashes. Symptoms of drug allergy Failure to record the number of hot flashes in the relevant checklists
Inclusion criteria: Iranian women 40-60 years old; Married; With a history of childbirth; serum FSH level is more than 40 million units per ml; Lack of known physical or mental illness; Experience at least 3 hot flashes during the day;
Intervention groups
Intervention group1: Magestrol tablets 40 mg daily for 1 month
Intervention group 2: Medroxyprogesterone 10 mg daily for one month
Main outcome variables
Intensity of hot flushing and sweating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210412050945N1
Registration date:2021-05-02, 1400/02/12
Registration timing:prospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Samira Abdollahi
Name of organization / entity
Alborz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
s.abdolahi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of medroxyprogestron 10 mg and megestrol 40 mg on vasomotor symptom in menopause women
Public title
Comparison of the effects of medroxyprogestron and megestrol on vasomotor symptom in menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian women 40-60 years old
Married
With a history of childbirth;
She had the last period 12 month later and serum FSH level is more than 40 million units per ml;
Lack of known physical or mental illness;
Experience at least 3 hot flashes during the day
No addiction or smoking, hookah or alcohol
Body mass index less than or equal to 29
Minimum literacy
Women with and had at least one of the symptoms of menopausal vasomotor
Natural menopause and menopause due to ovarian removal
No known mental illness
Exclusion criteria:
Regular exercise program
Vegetarian diet
Consume soy and its products more than once a week
Current use of drugs that affect hot flashes.
Symptoms of drug allergy
Failure to record the number of hot flashes in the relevant checklists
Taking any medicine during research
The presence of severe stress during treatment
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Women who consented to participate are randomly selected to receive either medroxyprogestron or megestrol . Group assignment is determined from a computer-generated table of random numbers. Some opaque envelopes were used for concealment
Blinding (investigator's opinion)
Triple blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Patients are unaware of the type of treatment
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
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-01-19, 1399/10/30
Ethics committee reference number
IR.ABZUMS.REC.1399.258
Health conditions studied
1
Description of health condition studied
Menopausal hot flashes
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Intensity of hot flashes
Timepoint
Before and one month after the intervention
Method of measurement
cooperman questionnaire
2
Description
Sweating rate
Timepoint
Before and one month after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magestrol tablets 40 mg daily for 1 month
Category
Treatment - Drugs
2
Description
Intervention group: Medroxyprogesterone 10 mg daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Samira Abdollahi
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 3021
Email
kamali@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?