Comparison of the Therapeutic effect of Oral Contraceptives with and without Dopamine Agonist ( Cabergoline ) in Reducing the Size of Ovarian Benign Tumors
This study will be done with the aim of assessing the therapeutic effect of administration of Oral Contraceptives with or without Dopamine Agonist (Cabergoline), in reducing the size of benign ovarian tumors.
Design
َA randomised, single centered, triple blinded clinical trial with parallel intervention and control groups; consisting of 40 participants.
Settings and conduct
The setting is Tabriz Alzahra Hospital. Participants, using a single randomization procedure, will be divided into two groups.Group 1 will receive Oral Contraceptives and group 2 will receive Cabergoline and Oral Contraceptives for 3 months. At the end of this time the size of benign ovarian tumors in two groups will be compared. The study is triple blinded meaning that the researcher, participants and analyst will not be aware of the division of
the two groups.
Participants/Inclusion and exclusion criteria
Participants in this study will be all women with benign ovarian tumors in reproductive age. Inclusion criteria: All women with benign ovarian tumors in reproductive age. Non inclusion criteria: hyperprolactinemia; hypercoagulability state and valvular heart disease.
Intervention groups
Control group will receive Oral Contraceptives, and Intervention group will receive Oral Contraceptives and Cabergoline( dopamine agonist ).
Main outcome variables
The size of benign ovarian tumors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180815040802N1
Registration date:2018-08-27, 1397/06/05
Registration timing:registered_while_recruiting
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Marzieh Parizad nasirkandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9161
Email address
parizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Therapeutic effect of Oral Contraceptives with and without Dopamine Agonist ( Cabergoline ) in Reducing the Size of Ovarian Benign Tumors
Public title
Therapeutic Effect of Dopamine Agonist ( Dopamine ) in Comparison with Oral Contraceptives in Reducing the Size of Ovarian Benign Tumors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women with Benign Ovarian Tumors in Reproductive Age
Exclusion criteria:
Hyperprolactinemia
Hypercoagulability State
Valvular Heart Disease
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The Participants, will be divided into 2 groups with a single randomization procedure(computer generated random numbers). Each group consists of 20 participants.Group 1 will receive Oral Contraceptives and group 2 will receive Cabergoline and Oral Contraceptives.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is triple blinded meaning that the researcher, participants, and analyst will not be Aware of the Division of 2 Groups.
Placebo
Not 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
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.411
Health conditions studied
1
Description of health condition studied
Benign Ovarian Tumors
ICD-10 code
D27
ICD-10 code description
D27:Benign neoplasm of ovary
Primary outcomes
1
Description
Size of benign ovarian tumor
Timepoint
measuring the size of tumor before intervention and after the 3 months; receiving drug
Method of measurement
Trans Vaginal Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants will receive 25 milligram Cabergoline ( dopamine agonist) tablets orally twice a week and Oral Contraceptives daily for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Participants will receive only Oral Contraceptives daily for 21 days monthly, then continue after the interval of about 8 days with next month; using for 3 months