Determining the effect of treatment, vaginal bromocriptine and dienogest on the ultrasound image and the amount of bleeding and pain caused by adenomyosis.
Design
This is a clinical trial study with two control groups, randomized, double-blind, the study population, the number of 60 patients, 30 people in the control group 1 with vaginal bromocriptine and 30 people in the control group 2 with Dienogest are compared. The rand function of Excel software was used for randomization.
Settings and conduct
This is a clinical, randomized, double-blind experimental study, the study population is adenomyosis patients referred to Rasul Akram Hospital in 2019-1400. The number of 60 people (30 people under treatment group with vaginal bromocriptine and 30 people under treatment group with dienogest) will be included in the study. The procedure will be that TVU will be performed for all patients (vaginal ultrasound ultrasound) at first.
Participants/Inclusion and exclusion criteria
Entry conditions: women with adenomyosis aged 35-35, infertility, use of contraceptive methods, confirmation of the disease using TVU vaginal ultrasound diagnostic tests. Conditions for non-entry: pregnancy or starting treatment for adenomyosis at least 3 months before.
Intervention groups
To determine the effect of treatment.
Vaginal bromocriptine and oral dienogest on ultrasound appearance and amount of bleeding and pain caused by adenomyosis.
Two control groups, group 1, vaginal bromocriptine treatment and group 2, oral dienogest, are compared.
Main outcome variables
Adenomyosis; Ultrasound of Adenomyosis; The pain; Menstruation; Vaginal Bromocriptine; Dynogest.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230407057838N1
Registration date:2023-08-21, 1402/05/30
Registration timing:retrospective
Last update:2023-08-21, 1402/05/30
Update count:2
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Parvaneh Bahorzahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 547 9438
Email address
parbah62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
2021-10-02, 1400/07/10
Actual recruitment end date
2022-08-23, 1401/06/01
Trial completion date
2023-03-18, 1401/12/27
Scientific title
Comparison of the therapeutic effect of vaginal bromocriptine and dienogest on ultrasound and bleeding and pain due to adenomyosis
Public title
"vaginal bromocriptine" and" dienogest" on the treatment of adenomyosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of 6 months of painful and regular menstruation
Exclusion criteria:
Not having a history of specific diseases (including epilepsy, gastrointestinal, cardiovascular, renal disorders) according to the person's own statement.
No allergies to dienogest and bromocriptine
Absence of important gynecological disease orAbdominal and pelvic surgery in the last 6 months
Age
From 35 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
40
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
Research Ethics Committees of School of Medicine
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
تهرانTehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
IR.IUMS.FMD.REC.1400.361
Health conditions studied
1
Description of health condition studied
Adenomyosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
State of uterine view
Timepoint
The condition of the uterus is checked at the beginning of the study (before the start of the intervention) and 3, 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
Method of measurement
Vaginal ultrasound
2
Description
Pain
Timepoint
The intensity of pain at the beginning of the study (before the start of the intervention) and 3, 6 and 9 months after the start of taking the drugs vaginal bromocriptine and dinogest.
Method of measurement
"Visual pain measurement tool" questionnaires are used to evaluate pain.
3
Description
Blood loss
Timepoint
The amount of bleeding is checked at the beginning of the study (before the start of the intervention) and 3, 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
Method of measurement
A "visual chart of blood loss" is used to evaluate changes in menstrual symptoms.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Bromocriptine (Iran Hormone Company) in the amount of 2.5 mg, 2 tablets, daily, vaginally for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group 2: Dienogest (Iran Hormone Company) at the rate of 2 mg, 2 tablets, daily, vaginally for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
bahorzahi parvaneh
Street address
Tehran-Starkhan-Kh.Niyaish-Corner of Mansouri St.- Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
Rasoolhospital@iums.ac.ir
Web page address
https://hrmc.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
keyvanihosin
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, 5th floor of the central headquarters
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
keyvani.hiums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?