The aim of this study is the evaluation of requirement to myomectomy in women with symptomatic (too bleeding) myoma (fibroids) after the injection of Tryptorelin acetate (Decapeptyll). Interventional study with Parallel pattern designed and sampling is randomly for case and control groups. The total sample size was 48. 24 patients in control group and 24 in experimental group. Inclusion criteria: women with myoma are not menopausal and do not use other medicines to improve myoma. Exclusion criteria: patient disagreement to participate in the study. Women with myoma were randomly divided into control and test groups. In the experimental group, after routine examination, Decapeptyl 3/75 mg injected intramuscularly in the gluteal region and dorsogluteal deaply once every 28 days for 6 months (Intervention on days 28, 56, 84, 112, 140 and 168 of the cycle). The control group will using Dydrogesterone 20mg to reduce the symptoms of myoma from the 5th day of menstural cycle for 20 days. About the ability of decapeptyl to improve myoma and decrease surgeries there is different responses in different places.
This study is triple blinde and Blinding is done for patients in the study, participants were evaluated to measure the outcome and the committee.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041421653N1
Registration date:2015-06-15, 1394/03/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-15, 1394/03/25
Registrant information
Name
Athar Rasekh Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 5432 6602
Email address
a.rasekh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahram University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of requirement to myomectomy in women`s with symptomatic myoma (fibroid) after the injection of Triptorelin acetate (decapeptyl)
Public title
Requirement to myomectomy in women with myoma(fibroid) after treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non menopausal wemon with myoma; not using another drugs; myoma has symptoms like pain and bleeding even with small size but large number.
Exclusion criteria:menopausal women; using another drugs except decapeptyl for treatment; notsymptomatic myoma; allergic or intestinal reactions after getting drug.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Motahari Street, Jahrom, Fars
City
Jjahrom
Postal code
Approval date
2015-03-21, 1394/01/01
Ethics committee reference number
Jums.REC.1393.100
Health conditions studied
1
Description of health condition studied
leiomyoma
ICD-10 code
D25
ICD-10 code description
benign neoplasms of uterus with morphology code M889 and behaviour code /0
Primary outcomes
1
Description
Lleiomyoma Size
Timepoint
Intervention on days 28, 56, 84, 112, 140 and 168 of the cycle
Method of measurement
mm. sonography
Secondary outcomes
1
Description
Frequency of myomectomy
Timepoint
End of study
Method of measurement
Enumeration
Intervention groups
1
Description
Intervention group: Dcapeptyl 3/75 mg dose will injected intramuscularly in the gluteal region and by dorsogluteal pattern and deeply once every 28 days for 6 months (intervention on days 28, 56, 84, 112, 140 and 168 cycles menstruation).
Category
Treatment - Drugs
2
Description
control group: control group will using Dydrogesterone 20mg from the 5th day of menstural cycle for 20 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Athar Rasekh Jahromi Clinic
Full name of responsible person
Athar Rasekh Jahromi
Street address
Farmandari Street, Jahrom, Fars
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahram University of Medical Sciences
Full name of responsible person
Abas Rahmnian
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahram 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
Jahrom University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Obstetricians
Other areas of specialty/work
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Postal code
Phone
+98 71 5433 6085
Fax
Email
drrasekh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahram University of Medical Sciences
Full name of responsible person
Athar Rasekh Jahromi
Position
Obstetricians
Other areas of specialty/work
Street address
Motahari Street, Jahrom, Fars
City
Jahrom
Postal code
Phone
+98 71 5433 6085
Fax
Email
drrasekh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)