Comparing the effect of Oral Contraceptive LD and Vitex on improvement clinical and paraclinical parameters of Polycystic ovarian syndrome (PCOS): a double blind randomized controlled clinical trial
The aim of this randomized controlled trial (double blind ) is comparing the effect of Oral Contraceptive LD and Vitex on improving clinical and para-clinical parameters of Polycystic ovarian syndrome (PCOS). 80 women aged 18 to 45 years old with PCOS will be recruited in the study. This study will be conducted at Alzahara hospital and Clinics affiliated to Tabriz University of Medical Sciences. Eligible women will be selected through convenience sampling and will be randomly assigned into 2 groups involving 40 subjects using permuted block randomization with allocation ratio of 1:1. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Intervention group will receive Vitex agnus tablet two pills daily for three cycles of 28 days and control group will receive LD tablet one pill daily for first 21 days of each cycle through three cycles of 28 days. The last seven tablets in LD group contain placebo. Main outcome measure is menstrual cycle length which will be evaluated by calendar one , two, and three months after the intervention. Secondary outcomes include Serum levels of dehydroepiandrosterone sulfate, free testosterone and prolactin that will be assessed by Enzyme-linked immunosorbent assay (ELISA) before the intervention and three months after intervention.The researcher and the participants will be blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306116709N13
Registration date:2014-03-02, 1392/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-02, 1392/12/11
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz university of medical sciences
Expected recruitment start date
2014-01-10, 1392/10/20
Expected recruitment end date
2014-06-30, 1393/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Oral Contraceptive LD and Vitex on improvement clinical and paraclinical parameters of Polycystic ovarian syndrome (PCOS): a double blind randomized controlled clinical trial
Public title
Comparing the effect of Oral Contraceptive LD and Vitex to treat Polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: oligomenorrhea or amenorrhea (menstrual intervals longer than 35 days or no menstruation in the last three months); polycystic ovarian confirmed by ultrasound; age 45-18 years; willingness to participate in the study; Body mass index between 18 and 35. Exclusion criteria: having other androgenic disorders such as adrenal hyperplasia or androgen-producing tumors; contraindications of oral contraceptive LD including: smokers over 35 years, active liver diseases, systolic blood pressure equal to or above 140 mm Hg and diastolic equal to or above 90 mm Hg , diabetes for more than 20 years, gallbladder diseases, history of stroke, blood clots in the legs or lungs, heart attack and other cardiovascular problems, breast cancer, migraine with aura,... ; thyroid diseases; cushing's syndrome; currently taking oral contraceptives or other hormonal treatments; pregnancy; breastfeeding; history of surgery on one or both ovaries; taking dopamine antagonist drugs such Thioridazine, Promazine, Metoclopramide, Hydroxyzine, etc
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics committee of Tabriz university of Medical Sciences
One month, two months, three months after the intervention
Method of measurement
Calendar
Secondary outcomes
1
Description
Serum Dehydroepiandrosterone sulfate level
Timepoint
Before the intervention and three months after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
2
Description
Serum free testosterone level
Timepoint
Before the intervention and three months after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
3
Description
Serum prolactin levels
Timepoint
Before the intervention and three months after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
Intervention groups
1
Description
Intervention group: Vitex agnus tablet, containing standardized pure extract of Vitex agnus fruits with 2.1 to 3.3 mg acubin, two pills daily for three cycles of 28 days .
Category
Treatment - Drugs
2
Description
Control group: LD tablet, containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel, one pill daily for first 21 days of each cycle through three cycles of 28 days. The last seven tablets in LD group contain placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Parvaneh Ghahremani nasab, Master of sciences student in midwifery
Street address
Baghshomal square, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr mohammadreza Rashidi
Street address
Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parvaneh Ghahremani nasab
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
South Shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5173957675
Phone
+98 41 1478 8109
Fax
Email
ghahremani.parvaneh@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Master of Sciences of Midwifery
Other areas of specialty/work
Street address
South Shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
51745347
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
mshahnazi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvaneh Ghahremani nasab
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
South Shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
51745347
Phone
+98 41 1478 8109
Fax
Email
ghahremani.parvaneh@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)