We aimed to compare acceptability of levonorgestrel with the Yuzpe regimen among Iranian women based on their side-effects and resulting changes in the amount and pattern of menses.
five hundred twenty nine participants aged 15-49 having regular menses and one act of unprotected intercourse within 72 h were included in the double-blind, controlled trial and randomly assigned into LNG (n=263) and HD (n=266) groups, receiving levonorgestrel 0.75 mg given 12 h apart and ethinyl estradiol 100 μg plus 0.5 mg levonorgestrel 0.5 mg repeated after 12 h, respectively.
Between 12 Sep 2006 and 25 Jun 2007 After complying with inclusion criteria participants were asked to sign the written consent. Participants were then classified into two groups (i.e. HD regimen and LNG regimen groups) according to balanced black randomization. Four tablets in the same size, shape, and color were put in each set. Neither the obstetrics, nor the participants were aware of the type of tablets in each set (double-blind). Only the person responsible for randomization was aware of the contents of the sets according to the serial numbers stuck on the sets.
Levonorgestrel regimen (LNG group) consisted of two sets; each one contained a 0.75 mg levonorgestrel and a placebo tablet; the pills in each set were taken at once and the sets were taken 12 h apart. Yuzpe regimen (HD group) consisted of four white tablets; two HD pills were put in a set. The pills in each set were taken at once and the sets were taken 12 h apart. The third dose (two pills) was also given to the participants to be taken if regurgitating within two hours of drug administration. The first set of tablets was taken in presence of the obstetrics and the second set was taken at home 12 h later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091112307N2
Registration date:2013-09-14, 1392/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-14, 1392/06/23
Registrant information
Name
Fatemeh Sadat Hoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 7062
Email address
fshoseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
partly by Deputy Ministry for Research Tehran University of Medical Sciences, grant #132/10442 and in part by Population Family and School Health Dept., Ministry of Health and Medical Education
Expected recruitment start date
2006-08-12, 1385/05/21
Expected recruitment end date
2007-05-25, 1386/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized, Controlled Trial of Levonorgestrel Vs. The Yuzpe Regimen as Emergency Contraception Method among Iranian Women
Public title
A Randomized, Controlled Trial of Levonorgestrel Vs. The Yuzpe Regimen as Emergency Contraception Method among Iranian Women
Purpose
Prevention
Inclusion/Exclusion criteria
Eligible participants were sexually active women aged between 15 and 49 years having regular menstrual cycles of 24-42 days. We also included women having only one act of unprotected intercourse within current cycle and they were asked to take the pills within 72 h of the unprotected intercourse. In addition, the failed contraceptive method was determined to be condom or conventional method. Breast-feeding women were also included provided that their baby was older than 6 months.
Exclusion criteria were breast-feeding women with their baby younger than 6 months, hormonal contraindications in their current cycle, use of hormonal contraceptives, uncertainty about the time of LMP, and suspected pregnancy
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
529
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research of Tehran University of Medical Science
Street address
Floor 6th,Deputy of Research of Tehran University of Medical Science,Ghods street,Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2006-07-12, 1385/04/21
Ethics committee reference number
130/677
Health conditions studied
1
Description of health condition studied
Family planning / Contraception
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Comparison of side effects of Levonorgestrel Vs. The Yuzpe Regimen as Emergency Contraception Method among Iranian Women
Timepoint
after a week, one week after the latest Expected mense
Method of measurement
Questionnaire, talk to women
2
Description
The Comparison of pattern of menses of Levonorgestrel Vs. The Yuzpe Regimen as Emergency Contraception Method among Iranian Women
Timepoint
at the first day, after a week, one week after the latest Expected mense
Method of measurement
Questionnaire, talk to women
3
Description
The Comparison of unwanted pregnancy rate of Levonorgestrel Vs. The Yuzpe Regimen as Emergency Contraception Method among Iranian Women
Timepoint
one week after the time of latest Expected mense
Method of measurement
Questionnaire,taik to women,Serum BHCG titer in retarded mense
Secondary outcomes
1
Description
Determination of the knowledge of iranian women about emergency contraception methods
Timepoint
at the first day
Method of measurement
Questionnaire,talk to women
Intervention groups
1
Description
Levonorgestrel regimen (LNG group) consisted of two sets; each one contained a 0.75 mg levonorgestrel and a placebo tablet; the pills in each set were taken at once and the sets were taken 12 h apart
Category
Prevention
2
Description
Yuzpe regimen (HD group) consisted of four white tablets; two HD pills were put in a set. The pills in each set were taken at once and the sets were taken 12 h apart
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Family planning of health care centers of Gilan University of Medical Sceinces
Full name of responsible person
Street address
City
Rasht/Bandar Anzali
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
by Deputy Ministry for Research Tehran University of Medical Sciences,Population Family and School H
Full name of responsible person
Mommad Eslami,Akbar Fotohi
Street address
Floor 6th, Deputy of Research of Tehran University of Medical Science, Ghods street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
by Deputy Ministry for Research Tehran University of Medical Sciences,Population Family and School H
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
Teran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Research Employee and Student PhD of Reproductive Biology
Other areas of specialty/work
Street address
Floor 6th,Deputy of Research of Tehran University of Medical Science,Ghods street,Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
Email
fshoseini@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Research Employee and Student PhD of Reproductive Biology
Other areas of specialty/work
Street address
Floor 6th,Deputy of Research of Tehran University of Medical Science,Ghods street,Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 8168 3619
Fax
Email
fshoseini@razi.tums.ac.irhoseini_fs@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hoseini
Position
Research Employee and Student PhD of Reproductive Biology
Other areas of specialty/work
Street address
Floor 6th,Deputy of Research of Tehran University of Medical Science,Ghods street,Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
Email
fshoseini@razi.tums.ac.ir hoseini_fs@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)