Protocol summary

Study aim
Determining the effect of magnesium on postmenopausal women’s sexual function and severity of menopausal symptoms.
Design
Two arms, parallel-group, triple blinded randomized trial with a control group, phase 3 on 112 participants. Block randomization will be used for randomization.
Settings and conduct
From the five comprehensive health service centers affiliated to Shahid Beheshti University of Medical Sciences, which were randomly selected, postmenopausal women were randomly selected, and the eligible people were divided into group A and B by block randomization method. Before the intervention, demographic and obstetric profile form, female sexual function index (FSFI) and menopause rating scale (MRS) will be completed by the samples.Women will receive the envelope with the same name as their group (A or B) based on which of the two groups they are randomly placed in. Coding will be done by the pharmacist. After the completion of the intervention, the magnesium serum level will be measured again and the questionnaires will be completed too. Then the collected data will be analyzed and the results will be interpreted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: menopausal women, sexually active, absence of underlying disease affecting sexual function, absence of diseases that lead to malabsorption, absence of magnesium deficiency, absence of hormone replacement therapy, not using of chemical or herbal drugs that affect sexual function or the severity of menopausal symptoms. Exclusion criteria: failure to take medication regularly, unwillingness to continue participating in the study, interruption of sexual activity during the study.
Intervention groups
Two groups will participate in this research. Magnesium tablets will be given to the intervention group and placebo to the control group.
Main outcome variables
Sexual function; Severity of menopausal symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150128020854N13
Registration date: 2024-03-11, 1402/12/21
Registration timing: prospective

Last update: 2024-03-11, 1402/12/21
Update count: 0
Registration date
2024-03-11, 1402/12/21
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of magnesium on postmenopausal women’s sexual function and severity of menopausal symptoms
Public title
Investigating the effect of magnesium on postmenopausal women’s sexual function and severity of menopausal symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian. At least they should be able to read and write. Lack of speech, hearing or mental disorders that prevent communication with the researcher. At least one year has passed since the last menstruation. Being in the first five years of menopause. Have sexual activity in the last 6 months. Do not have magnesium deficiency (based on lab test). Do not use hormone replacement therapy. Do not use any chemical or herbal drug (ginseng, vitagenus, maca, femexite capsule, flibanserin) effective on sexual function (according to the self-report). Do not use any chemical or herbal drug to reduce the severity of menopausal symptoms (hot flashes, sleep disorders, etc.) (according to the self-report). Not using complementary and alternative medicine to reduce the severity of menopausal symptoms (yoga, acupuncture or other methods). Do not use multivitamins or minerals. Do not have diseases that affect sexual function (such as musculoskeletal diseases, multiple sclerosis, endometriosis, diabetes, hypertension) according to the self-report. Their spouses do not suffer from sexual problems (such as erectile dysfunction or premature ejaculation according to the self-report). Have not undergone hysterectomy and oophorectomy, cystocele and rectocele, and mastectomy. Lack of known mental illness in women and their spouses according to the self-report. Lack of addiction to cigarettes, alcohol or drugs. Do not have dietary restrictions. Do not suffer from kidney diseases, chronic diarrhea and diseases that lead to malabsorption (celiac, Crohn's disease, etc.) (according to the self-report). Lack of specific event or incident that represents a crisis in their life, such as death or incurable illness of family members, change of residence, loss of job since 6 months ago and marital infidelity, and not being on the verge of divorce. Menopause occurs naturally (not followed by oophorectomy). Premature menopause does not occurred. Have no marital conflicts. Obtaining a score of 5 or higher from the MRS questionnaire.
Exclusion criteria:
Use of corticosteroids, furosemide, hydrochlorothiazide, pantoprazole, omeprazole, drugs to prevent organ transplant rejection, and amphotericin B during the study. Failure to take medication regularly (if less than 51 tablets (that is less than 90% of all tablets) are taken). Unwillingness to continue participating in the study. Interruption of sexual activity during the study for any reason (such as illness, death of spouse, etc.).
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the block randomization method is used to balance the number of samples assigned to each of the study groups. In fact, block randomization is done to make sure that exactly the same number of participants are placed in the intervention and control group in a consecutive but equal time intervals. For this purpose, a block table designed by a statistical consultant is used, in which code A and code B drugs are randomly distributed among the samples based on the table. The distribution of coded drugs among samples is random and there is no order in the distribution of drugs. This table is arranged randomly randomly with the rand command in Excel software and generates random numbers to the number of divalent blocks, 28 AB blocks and 28 BA blocks completely randomly. Then, in each block, placebo and magnesium intervention are assigned according to random blocks, and based on this, 112 research samples are placed in double random blocks. For example, the first sample of the first group is given the drug code A and the first sample of the second group is given the drug code B, and the second person of the first group is given the drug code B and the second person of the second group is given the drug code A. In fact, there will be no order in the distribution of drugs between the two groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drugs and placebos will be placed in separate envelopes with two codes A and B by pharmacist in the laboratory of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Placebo in this research means tablets that are adapted to magnesium tablets in terms of shape, size, color and smell and prepared in the laboratory of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences by a pharmacist and placed in similar envelopes. In fact, the drug and the placebo are exactly similar in terms of shape, size, color and smell. Coded envelopes are distributed among the samples. Therefore, the researcher, the research samples and the statistical consultant are not aware of the contents of the envelopes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, School of Nursing and Midwifery
Street address
Vali-e-Asr St. - Niayesh Intersection - In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-02-12, 1402/11/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.267

Health conditions studied

1

Description of health condition studied
postmenopausal women’s sexual function
ICD-10 code
ICD-10 code description

2

Description of health condition studied
severity of menopausal symptoms
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual function
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Female sexual function index

2

Description
Severity of menopausal symptoms
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Menopause rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: oral magnesium tablets, each tablet contains 250 mg magnesium oxide, 2 tablets daily (one in the morning after breakfast and one at night after dinner), for 4 weeks, constructed by Jalinous factory.
Category
Other

2

Description
Control group: placebo tablets, 2 tablets daily (one in the morning after breakfast and one at night after dinner), for 4 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kadoos Urban Comprehensive Health Services Center
Full name of responsible person
Dr. Dadkhodaei
Street address
No. 16, North Sajdeh'i St., Jashnvareh St., second floor of Tehranpars
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 7773 3312
Email
mbsh@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Imam Hasan Mojtaba (AS) Urban Comprehensive Health Services Center
Full name of responsible person
Roya Sahebi
Street address
No. 51, Bani Hashem Alley, 137th St., East 196th St., Parvin Square, Tehranpars
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 7735 8711
Email
mbsh@sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Samarghandi Urban Comprehensive Health Services Center
Full name of responsible person
Akram Baghbani
Street address
No. 175, between 206th St. and 212th St., Ordibehesht Boulevard, Farjam St.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 7707 0044
Email
mbsh@sbmu.ac.ir

4

Recruitment center
Name of recruitment center
Haj Mobaraki Urban Comprehensive Health Services Center
Full name of responsible person
Mirhashemi
Street address
No. 40, Shahrezaei St., Farshadi St., Lavizan
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 2293 6644
Email
mbsh@sbmu.ac.ir

5

Recruitment center
Name of recruitment center
Engineer Nader Urban Comprehensive Health Services Center
Full name of responsible person
Pantea Mahdavi
Street address
No. 58, Esfandani St., Jashnvareh St., second floor of Tehranpars
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 7733 0733
Email
mbsh@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sepideh Hajian
Street address
Vali-e-Asr St - Niayesh Intersection - In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
s.hajian@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Aghahossein Shirazi
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-e-Asr St - Niayesh Intersection - In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
z.shirazi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hedyeh Riazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vali-e-Asr St - Niayesh Intersection - In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
h.riazi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Aghahossein Shirazi
Position
Midwifery Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vali-e-Asr St - Niayesh Intersection - In front of Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
z.shirazi@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
If there is a logical reason, it will be provided to the journal for publication of the article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristics and findings related to the main outcome variable will be published in the paper.
When the data will become available and for how long
After the publication of the paper.
To whom data/document is available
Researchers
Under which criteria data/document could be used
Other statistical analysis
From where data/document is obtainable
Dr. Hedyeh Riazi h.riazi@sbmu.ac.ir
What processes are involved for a request to access data/document
After counseling with the research team, the data will be provided to the applicant, which will be probably a one-month process.
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