A randomized clinical trial will be performed on 1000 women who are candidate for hormonal contraception. The women will be randomly divided into the 2 groups. In the Cyclofem group, Cyclofem will be injected intramuscularly and will be repeated monthly, and in the second group low dose oral contraceptive pills (LD) will be prescribed. The women will be followed up to one year and the adverse effects of the 2 methods will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903242624N6
Registration date:2010-06-14, 1389/03/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Deputy of Research and Technology.
Expected recruitment start date
2010-07-01, 1389/04/10
Expected recruitment end date
2012-07-01, 1391/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the side effects of low dose combined contraceptive pills and Cyclofem
Public title
A comparison between the side effects of two methods of Contraception
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: non pregnant and married women who are 18-35 years old and are serious for not to be pregnant during the next year and their BMI is in the normal range (19-25). Exclusion criteria: history of breast cancer, endometrial cancer, abnormal uterine bleeding , being smoker, active or chronic liver disease , obstructive jaundice, liver adenoma or carcinoma, liver cirrhosis, thromboembolic disorders, heart disease, stroke, diabetes, hypertension, recurrent headache or dizziness, history of depression or anxiety, breast feeding, dislipidemia, any systemic disorder or any drug use for systemic disorders, AUB , Oligomenorhea.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat Highway, Chamran Cross.
City
Tehran
Postal code
Approval date
2010-07-07, 1389/04/16
Ethics committee reference number
1729909
Health conditions studied
1
Description of health condition studied
Contraception
ICD-10 code
Z30.0
ICD-10 code description
General counselling and advice on contraception
Primary outcomes
1
Description
adverse effects
Timepoint
1-3-6-12 months
Method of measurement
questionnaire
Secondary outcomes
1
Description
The frequency of discontinuation of contraception
Timepoint
1-3-6-12 months
Method of measurement
Questionnaire
Intervention groups
1
Description
low dose contraceptive pills (LD) 1 pill daily for 21 days/month and starting again 7 days later
Category
Treatment - Drugs
2
Description
Cyclofem, 1 injection monthly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Public health centers
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Dr. Motavallian
Street address
Hemmat Highway, Chamran Cross.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Deputy of Research and Technology