Protocol summary

Summary
The aim of this clinical trial multi centeral study was the comparison between efficacy of levonorgestrel single dose, with two doses of levonorgestrl and Yuzpe method as an emergency contraception. Informed consent was obtained. Inclusion Criteria: women within 120 hours of unprotected intercourse; regular menstrual cycles; No current use of any hormonal contraception; non smoker Exclusion Criteria: One or more acts of unprotected intercourse more than 120 hours current or recent use of hormonal methods of contraception; Women were randomly allocated in three groups: Group A received two doses of 0.75 mg LNG taken 12 h apart, Group B received the single dose of LNG(1.5 mg); and Group C received the yuzpe regime( four tab ocp contain 30 microgram ethinyl estradiol plus 0.15 mg levonorgestrel, each given twice, 12 hours apart totally 8 tab). The main variable is success rate in three interventional methods; B hCG test was performed after 3 weeks menstruation delay .Intrauterine pregnancy was confirmed by abdominal ultrasound .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106186826N1
Registration date: 2011-07-24, 1390/05/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Mahshid Bokaie
Name of organization / entity
Shahid Sadougi university of medical sciences,Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
mah_bokaie@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadougi University of Medical Sciences
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2011-05-07, 1390/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between efficacy of single dose levonorgestrel, with two dose levonorgestrl and Yuzpe as an emergency contraception
Public title
Three method for emergency contraception
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: present within 120 hours of unprotected intercourse; regular menstrual cycles and no current use of hormonal contraception Exclusion Criteria: One or more acts of unprotected intercourse more than 120 hours
Age
From 16 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Shahid Sadougi University of Medical Sciences
Street address
Yazd
City
Yazd
Postal code
Approval date
2009-02-11, 1387/11/23
Ethics committee reference number
107515

Health conditions studied

1

Description of health condition studied
Family planning
ICD-10 code
Z30
ICD-10 code description
Contraceptive management

Primary outcomes

1

Description
Unwanted pregnancy
Timepoint
Three week after unprotect intercourse
Method of measurement
Beta HCG titer

Secondary outcomes

1

Description
Menstural pattern in next month
Timepoint
Next month
Method of measurement
Using check list

Intervention groups

1

Description
Longel (levonorgestrel 0.75 mg: Iran hormon Company:two tab(1.5 mg) single dose
Category
Treatment - Drugs

2

Description
Longel (levonorgestrel 0.75 mg) Iran hormon Company:one tab (0.75 mg) given twice, 12 hours apart
Category
Treatment - Drugs

3

Description
OCP Ovacept (LD:30microgr ethinylestradiol +15mg levonorgestrel:Aburahan Company :four tab each given twice, 12 hours apart)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Azad Shahr health center
Full name of responsible person
Street address
City
Yazd

2

Recruitment center
Name of recruitment center
Akbari health center
Full name of responsible person
Street address
City
Yazd

3

Recruitment center
Name of recruitment center
Rahmat Abad health center
Full name of responsible person
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadougi Universiy of Medical Sciences
Full name of responsible person
Fatemeh Ezodini Ardekani
Street address
Bahonar sq- Yazd -Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadougi Universiy of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadougi University of Medical Sciences
Full name of responsible person
Mahshid Bokie
Position
MS
Other areas of specialty/work
Street address
Nursing and Midwifery College. Yazd. Iran
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
mah_bokaie@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadougi University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
MS
Other areas of specialty/work
Street address
Nursing & Midwiferry Collage
City
Yazd
Postal code
Phone
+98 35 1824 1750
Fax
Email
mah_bokaie@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mahshid Bokaie
Position
MS
Other areas of specialty/work
Street address
Nursing & Midwiferry Collage
City
Yazd
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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