Objectives: Comparison of effect of Bromocriptine and Metformin on the menstrual cycle in young women with polycystic ovary. Design: Randomized, single-blind, single-center, phase II trial. Setting and conduct: Group A, 2.5 mg per day Bromocriptin is administered. Group B, two 500 mg Metformin pills per day is administered. Participants including major eligibility criteria: Inclusion criteria include presence of polycystic ovary; exclusion criteria include marriage. Intervention: Group A, 2.5 mg per day Bromocriptin is administered. Group B, two 500 mg Metformin pills per day is administered. Main outcome measures variable: menstrual cycle is evaluated after consumption of drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512313461N7
Registration date:2016-03-16, 1394/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-16, 1394/12/26
Registrant information
Name
Firoozeh Veisi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 4276
Email address
f_veisi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Bromocriptine and Metformin on the treatment of menstrual pattern in young women with polycystic ovary syndrome
Public title
effects of Bromocriptine and Metformin on polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : menstrual cycles greater than 40 days; acnea; hirsutism; pco on sonography; LH/FSH ratio greater than 2; normal prolactin; normal TSH; excess androstenedione; normal blood sugar. Exclusion criteria: marriage; psychiatric drug users; professional athletes; primary amenorrhea; history of chronic illnesses; body mass index greater than 30 kg/m2.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
Vice chancellor for Research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
Kums.REC.1394.220
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Menstrual pattern
Timepoint
Before , 3 and 6 months after intervention
Method of measurement
Questionnaire, menstrual cycle days measurement
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 : 5 mg of bromocriptine daily is administered . In the first week 1.25 mg and after that 1.25 mg weekly is added until 5 mg per day.
Category
Treatment - Drugs
2
Description
Group 2 : a daily dose of 1000 mg of metformin is administered. In the first week 250 mg and after that 250 mg weekly is added until to 2 pills a day.