Relation between androgen hormone with sexual function in women use LD attending in selected Health centers of shiraz university of medical sciences in 2012-2013
The objective of this prospective study is to consider relation between androgen hormone with sexual function in women use low-dose oral contraceptive (OC) containing 30 µg ethinylestradiol and 150 µg Levonorgestrel (LD). Eighty-nine married, healthy volunteers (age range, 18–35 years), having regular menstrual cycles participated in the study that have earned scores 28 or more of Female sexual function index (FSFI). Sexual function and androgen level was assessed by using the (FSFI) questionnaire and blood test at baseline, and at 3 months of pill use. If we will have sexual function disorder after pill use, we can offer another prospective method for couple that has no effect on sexual activity.
General information
Acronym
low dose contraceptive pill
IRCT registration information
IRCT registration number:IRCT2013070213846N1
Registration date:2013-09-22, 1392/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-22, 1392/06/31
Registrant information
Name
Elham Sheikhan Shamsabadi
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 2559
Email address
sheikhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research office of Shiraz University Of Medical Sciences
Expected recruitment start date
2013-08-12, 1392/05/21
Expected recruitment end date
2014-01-11, 1392/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relation between androgen hormone with sexual function in women use LD attending in selected Health centers of shiraz university of medical sciences in 2012-2013
Public title
Relation between androgen hormone with sexual function in women use LD
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate; married woman with age between 18-35 years old; having score 28 or more of Female Sexual Function Index; not pregnant; not having breast feeding; no history of heart disease and vascular disease (the patient's medical records); no history of uncontrolled hypertension and hypotension; no history of liver dysfunction; not taking any medications that affect sexual function (specially common antidepressant); not having migraine and ulcer; don’t use alcohol and cigarette; not sexual function disorder; regular mensturation.
Exclusion criteria : taking hormone pills particulary OCP; taking alchohl or tobacco; history of active peptic ulcer disease ; history of headaches including migraines; history of dysparunia or vaginismus.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
89
Randomization (investigator's opinion)
N/A
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
Shiraz University of Medical Sciences
Street address
Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2013-08-11, 1392/05/20
Ethics committee reference number
CT-92-6661
Health conditions studied
1
Description of health condition studied
female sexual dysfunction
ICD-10 code
F50-F59
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
Female sexual dysfunction
Timepoint
At the start of intervention- After 3 months of intervention
Method of measurement
Female Sexual Function Index Questionnaire
Secondary outcomes
1
Description
Improvement of sexual function
Timepoint
At the start of intervention- After 3 months of intervention
Method of measurement
Female Sexual Function Index Questionnaire
Intervention groups
1
Description
Intervention with oral contraceptive(low dose) for 3 month /daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Abolfazl clinic
Full name of responsible person
Khadije Abdali
Street address
20 meter of emam khomeini ,rahmat bolovar,shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Shiraz 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
Fatemeh College of Nursing And Midwifery,Shiraz University of Medical Sciences
Full name of responsible person
Khadije Abdali
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
1311971936
Phone
+98 71 1647 4254
Fax
Email
abdalikh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Full name of responsible person
Khadije Abdali
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
1311971936
Phone
+98 71 1647 4252
Fax
Email
abdalikh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Full name of responsible person
Elham Sheikhan Shamsabadi
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
1311971936
Phone
+98 71 1647 4254
Fax
Email
sheikhan@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)