The aim of this study is to evaluate the effect of contraceptive therapy on bone mineral density, cardiovascular factors, and lipid profiles of female athletes who are experienced amenorrhea/oligomenorrhea. Thirty elite female athletes competing in national teams or Tehran's medalists in 34 sport fields who have reported amenorrhea/oligomenorrhea participate in this study (based on Inclusion and exclusion criteria). Half of the participants take oral contraceptive (30 mug ethinyl estradiol and 150 mug levonorgestrel) for nine months. Bone mineral density, cardiovascular factors and lipid profiles will be measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904024251N1
Registration date:2010-09-12, 1389/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-12, 1389/06/21
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research committee of Iran University of Medical sciences
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2011-04-04, 1390/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of hormone therapy on bone mass density in amenorrhea/oligomenorrhea female athletes
Public title
The effects of hormone therapy on bone mass density in amenorrhea/oligomenorrhea female athletes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian elite female athletes, presence of amenorrhea/oligomenorrhea
Exclusion criteria: regular menstruation pattern before beginning of the study, cessation of exercise, using hormonal medication, calcium supplement, or thyroid hormone
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Committee of Iran University of medical science.
Street address
Cross Expway of Shahid Hemmat & Shahid Chamran.
City
Tehran
Postal code
15875-6171
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
172994
Health conditions studied
1
Description of health condition studied
Amenorrhea/Oligomenorrhea
ICD-10 code
N91
ICD-10 code description
Absent, scanty and rare menstruation
Primary outcomes
1
Description
Menstrual pattern among athletes
Timepoint
Every month for nine months
Method of measurement
through coming to clinic or phone or fax or email for athletes who do not live in Tehran
2
Description
Bone mineral density
Timepoint
Baseline and after nine months
Method of measurement
Bone Densitometry maschine (HOLOGIC)
Secondary outcomes
1
Description
weight
Timepoint
Baseline and after nine monthsafter
Method of measurement
in kilograms by Balance
2
Description
Heart Rate and Blood pressure in supune position
Timepoint
Baseline and after nine monthsafter
Method of measurement
stethoscope and Blood pressure cuff
3
Description
waist circumference
Timepoint
Baseline and after nine monthsafter
Method of measurement
in centimeters by Tape
4
Description
Height
Timepoint
Baseline and after nine monthsafter
Method of measurement
in centimeters by Tape
5
Description
Lipid profile include (Total cholestrol (LDL, HDL), TG, Apo a and Apo b)
Timepoint
Baseline and after nine monthsafter
Method of measurement
Blood sample
6
Description
cardiovascular factors (hemocystein and Fibrinogen)
Timepoint
Baseline and after nine monthsafter
Method of measurement
Blood sample
Intervention groups
1
Description
oral contraceptive (30 mug ethinyl estradiol and 150 mug levonorgestrel) for 9 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rassole Akram Hospital
Full name of responsible person
Haleh Dadgostar MD
Street address
Sattarkhan St. Shahr-Ara St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research committee of Iran University of Medical Sciences
Full name of responsible person
Mazyar Moradi Lakeh MD
Street address
Crossroads of shahid Hemmat & shahid Chamran Expressways.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research committee of Iran University 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
Iran University Of Medical Sciences
Full name of responsible person
Haleh Dadgostar MD
Position
Assistant professor
Other areas of specialty/work
Street address
Rasoole Akram Hospital, Shar_Ara st., Sattarkhan st.
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
halehd@iums.ac.ir hldadgostar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgostar MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasoole Akram Hospital, Shar_Ara st., Sattarkhan st.
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
halehd@iums.ac.ir hldadgostar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Ghazaleh Soleimany
Position
Assistant
Other areas of specialty/work
Street address
Rasoole Akram Hospital, Shar_Ara st., Sattarkhan st.
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
ghazaleh_soleimany@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)