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Comparing the Effect of Melatonin with Placebo in Combination with Medroxy Progesterone in Women with Polycystic Ovarian Syndrome

Protocol summary

Study aim
Specific goals: 1. Comparison of changes in the ratio of LH to FSH in patients before and after the intervention, between the two groups receiving melatonin and placebo 2. Determining the effectiveness of melatonin in improving the quality of life in PCOS patients (based on PCOSQ questionnaire) 3. Comparison of changes in BMI in patients before and after the intervention, between the two groups receiving melatonin and placebo 4. Determining the effectiveness of melatonin in improving hirsutism in PCOS patients (based on Ferriman-Gallwey scoring system) Practical purposes: Finding a new strategy in the treatment of patients with PCOS
Design
Two arm parallel groups, double-blinded, randomized by permuted block randomization method, phase 2 clinical trial with 88 patients
Settings and conduct
This research will be performed in the gynecology clinic of Shariati hospital and in the field of PCOS. After two-way blindness and randomization, patients are divided into two groups. They will receive the mentioned medicines for 12 weeks. Necessary checks are done before starting and after finishing.
Participants/Inclusion and exclusion criteria
Inclusion: Women in reproductive age who diagnosed with PCOS based on Rotterdam criteria. most of the patients are new cases. Exclusion: Breastfeeding, adrenal hyperplasia, hyperprolactinemia, mental disorders, hypothyroidism.
Intervention groups
Intervention group: 6mg melatonin daily + 10 mg medroxyprogesterone since 16th day of cycle for two weeks Control group: placebo + 10 mg medroxyprogesterone since 16th day of cycle for two weeks
Main outcome variables
The main consequence is improving the clinical symptoms of a PCOS patient, which is achieved by reducing the ratio of LH to FSH, weight, hirsutism, and improving the quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200711048078N1
Registration date: 2020-08-27, 1399/06/06
Registration timing: prospective

Last update: 2020-08-27, 1399/06/06
Update count: 0
Registration date
2020-08-27, 1399/06/06
Registrant information
Name
Fatemeh sadat Ayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2278 0091
Email address
fsayati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-29, 1399/08/08
Expected recruitment end date
2021-05-24, 1400/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Melatonin with Placebo in Combination with Medroxy Progesterone in Women with Polycystic Ovarian Syndrome
Public title
Effect Evaluation of Melatonin in treatment of Polycystic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women in reproductive age (18-45) Women diagnosed with PCOS, based on Rotterdam criteria Who doesn't want to get pregnant for at least 3 months Most of patients are new cases If the patient has a medical history of taking medicines, should discontinue medications for at least 3 months before entering the study
Exclusion criteria:
Breastfeeding Wants to get pregnant Adrenal Hyperplasia Hyper Prolactinemia Mental Disorders Hypothyroidism Patients using hormonal medications or medications that cause weight loss and weight gain who's on a diet
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization: Random division is done in the form of "blocks" with a predetermined size and the number of people is evenly distributed among the study groups. Randomization unit: individual Randomization Tools: Statistical Software
Blinding (investigator's opinion)
Double blinded
Blinding description
The process of research will be explained to the patients and a consent form will be obtained from them, but we do not inform them which group they belong to. In this research, the researcher and the advisor are clinical caregivers who do not know which patient is taking the drug and which is taking a placebo by using the coding method. The only person who knows what group each patient belongs to is the supervisor who knows the coding.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of The Institute of Pharmaceutical Sciences-Tehran University of Medical Sciences
Street address
16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences
City
Tehran
Province
Tehran
Postal code
14155-6451
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.TUMS.TIPS.REC.1399.031

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
LH (luteinizing hormone) to FSH (follicle stimulating hormone) ratio
Timepoint
Measurement of blood LH and FSH levels at the beginning and end of the study
Method of measurement
Blood test

2

Description
BMI (body mass index)
Timepoint
Measurement of height and weight at the beginning and end of the study
Method of measurement
Scale and stadiometer

3

Description
Quality of life
Timepoint
At the beginning and end of the study
Method of measurement
PCOSQ (polycystic ovarian syndrome quality of life questionnaire)

4

Description
Hirsutism
Timepoint
At the beginning and end of the study
Method of measurement
Ferriman-Gallwey scoring scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For 12 weeks, in addition to receiving basic treatment (from day 16 of the cycle for two weeks, 10 mg of medroxyprogesterone per night), she takes 6 mg of melatonin daily, as well as at night before bedtime.
Category
Treatment - Drugs

2

Description
Control group: For 12 weeks, in addition to receiving basic treatment (from day 16 of the cycle for two weeks, 10 mg of medroxyprogesterone per night), she takes placebo daily, as well as at night before bedtime.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gynecology clinic of Shariati hospital
Full name of responsible person
Fatemeh sadat Ayati
Street address
North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 2255 0050
Email
fsayati@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Hossein Ghahremani
Street address
Faculty of pharmacy, tehran university of medical science, 16 Azar street, Enghelab street
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 9102
Email
mhghahremani@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh sadat Ayati
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Street, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
00982164120
Email
fsayati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh sadat Ayati
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Street, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
00982164120
Email
fsayati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh sadat Ayati
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tehran University of Medical Science, 16 Azar Street, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
00982164120
Email
fsayati@gmail.com

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
There is no more information.
Study Protocol
Yes - There is 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
Information about the main outcome can be shared. Such as age, height, weight, LH and FSH concentration
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Available for pharmacists working in industry and clinics and obstetricians
Under which criteria data/document could be used
Please be contacted before using the information.
From where data/document is obtainable
Fatemeh sadat Ayati Mobile: 00989120338404 Non-academic Email: fsayati@gmail.com University Email: fs-ayati@student.tums.ac.ir
What processes are involved for a request to access data/document
Please be contacted before using the information.
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