Protocol summary

Study aim
Comparison of the effect of combined oral contraceptives (COCs) and vitamin D-C0Cs on ovulatory dysfunction bleeding in women of reproductive age
Design
Controlled clinical trial, phase 3, with two parallel groups, three blinds
Settings and conduct
This study will be performed in Kosar Hospital in Qazvin. A member of the non-research team involved in the selection of samples will determine the random allocation sequence using a computer program. Closed opaque envelopes will be used numbered in order to conceal the allocation. Eligible individuals will be randomly assigned to two groups using block sizes of 4 and 6 blocks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-45 years old women Have at least 2-3 months of history of excessive, prolonged and irregular bleeding Have a phone number to follow up. Exclusion criteria: Pregnancy Having any cervical abnormality Having any kind of severe psychological stress Having systemic diseases Taking vitamin D supplements for the past three months. Taking drugs that affect the menstrual cycle Having Premenstrual Syndrome Contraindications to the use of combined contraceptive pills
Intervention groups
In COCs group: capsul LD (containing 30 micrograms ethinyl estradiol and 150 micrograms levonorgestrel), 21 pieces with 9 placebo capsules for use In each cycle and in the COCs _ vitamin D group, combination capsules containing vitamin D (1000 units of calciferol) and LD (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) in the amount of 21 and then 9 vitamin D capsules a day, they will be placed in the same packets in three separate cycles for consumption
Main outcome variables
Amount of volume and days of menstrual bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110606006709N22
Registration date: 2021-02-24, 1399/12/06
Registration timing: registered_while_recruiting

Last update: 2021-02-24, 1399/12/06
Update count: 0
Registration date
2021-02-24, 1399/12/06
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-05-31, 1400/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the effect of Combined oral contraceptive pills (COCs) and vitamin D - COCs on Ovulatory dysfunction bleeding (AUB-O) in reproductive age women : A triple blind randomized controlled clinical trial
Public title
Comparison of the effect of COCs and vitamin D-COCs on ovulatory dysfunction Bleeding in reproductive age women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18-45 years old Have at least 2-3 months of history of excessive, long and irregular bleeding (lack of regular cycle 28-35, bleeding more than 7 days or heavy) Have a phone number to follow up.
Exclusion criteria:
Pregnancy Any cervical abnormality including cervical cancer, infection, trauma or polyp and uterine causes including: leiomyoma, infection, polyp, endometrial hyperplasia, endometrial neoplasia, cancer or the presence of a foreign body based on the patient's statement and medical records. Having any kind of severe psychological stress such as: separation of parents, death of first-degree family members, etc. in the last 6 months. Having any kind of systemic diseases, such as: thyroid disease (hypothyroidism and hyperthyroidism), adrenal glands, liver, kidney and blood disorders (von Willebrand disease, idiopathic thrombocytopenic purpura, and leukemia) based on the patient's statement and medical records. Daily and regular intake of vitamin D supplements for the past three months. Taking medications that affect the menstrual cycle and bleeding, such as: oral hormonal contraceptives, anticoagulants, serotonin inhibitors, antipsychotics, corticosteroids, hormonal supplements, phenytoin, or herbal supplements such as soy and ginseng. Having premenstrual syndrome. Have any absolute or relative contraindications to the use of combined contraceptive pills, including breast cancer, endometrial cancer, liver disease, deep vein thrombosis, smoking in people 35 years and older, cardiovascular disease, history of stroke, Diabetes, hypertension, migraine, hyperlipidemia, conditions requiring complete immobility, inflammatory bowel disease, major depression, and epilepsy require medication.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into two groups: COCs group, COCs group - Vitamin D using random blocking method with the size of four and six blocks with 1: 1 allocation ratio. Assignment sequence with the help of the researcher and using the software Random Allocation Software will be specified. To conceal the allocation, closed opaque envelopes will be prepared and numbered according to the number of samples. Envelope preparation and random allocation sequencing will be performed by the non-research person.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs and their placebo will be prepared by the pharmaceutical company in a completely similar way in terms of shape, color and smell. The researcher, participants, data analyst, and outcome reviewer are unaware of the type of intervention received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.TBZMED.REC.1399.1041

Health conditions studied

1

Description of health condition studied
Ovulatory dysfunction bleeding
ICD-10 code
N93.8
ICD-10 code description
Other specified abnormal uterine and vaginal bleeding

Primary outcomes

1

Description
Menstrual bleeding rate
Timepoint
Before the intervention, one month, two months and three months after the start of the intervention, after the end of the intervention
Method of measurement
Higham Questionnaire

2

Description
Number of menstrual bleeding days
Timepoint
Before the intervention, one month, two months and three months after the start of the intervention, after the end of the intervention
Method of measurement
Calendar

Secondary outcomes

1

Description
The duration of the menstrual cycle
Timepoint
Before the intervention, one month, two months and three months after the start of the intervention, after the end of the intervention
Method of measurement
Calendar

2

Description
Quality of life score
Timepoint
Before the intervention, after the end of the intervention
Method of measurement
SF-36 questionnaire

3

Description
side effects
Timepoint
The first, second and third months after the start of the intervention
Method of measurement
Side effects questionnaire

4

Description
Satisfaction of treatment
Timepoint
after the end of the intervention
Method of measurement
Patient Satisfaction Questionnaire

Intervention groups

1

Description
Control group: LD capsules (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel), 21 tablets with 9 placebo capsules daily, one for three cycles
Category
Treatment - Drugs

2

Description
Intervention group: Combination capsules containing vitamin D (1000 units of cholecalciferol) and LD (30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) of 21 and then 9 vitamin D capsules daily, one for three cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mahdis Goodarzvand Chegini
Street address
Kowsar Hospital ,Taleghani Street
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Fax
+98 28 3323 6380
Email
itkosar@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahdis Goodarzvand Chegini
Position
Msc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery ,South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 4226 3582
Fax
+98 41 3479 6969
Email
mahdis.chegini71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
mshahnazi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdis Goodarzvand Chegini
Position
Master of sciences student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 4226 3582
Email
mahdis.chegini71@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
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
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