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General information
The following items have been entered incorrectly, please correct them.
1- The time of ultrasound before the intervention is six months and nine months later.
2- In the intervention group, Dienogest 2 mg is a daily oral dose.
3- The realized statistics is 68.
4- Displacement of consequences.
5-Adding the criteria (( use of gonadotropin agonist or antagonist, hormonal contraceptive in the last three months)) in the main conditions of not entering the study before randomization.
6-1- History of specific diseases (including epilepsy, gastrointestinal, cardiovascular, renal disorders) according to the person's own statement.
2- Allergy to dienogest and bromocriptine.
3- Existence of important gynecological disease or abdominal and pelvic surgery in the last 6 months.
The following items have been entered incorrectly, please correct them.
1- The time of ultrasound before the intervention is six months and nine months later.
2- In the intervention group, Dienogest 2 mg is a daily oral dose.
3- The realized statistics is 68.
4- Adding the secondary outcome "Uterine position" and removing it from the primary outcomes.
5-Adding the criteria (( use of gonadotropin agonist or antagonist, hormonal contraceptive in the last three months)) in the main conditions of not entering the study before randomization.
6-1- History of specific diseases (including epilepsy, gastrointestinal, cardiovascular, renal disorders) according to the person's own statement.
2- Allergy to dienogest and bromocriptine.
3- Existence of important gynecological disease or abdominal and pelvic surgery in the last 6 months.
The following items have been entered incorrectly, please correct them. 1- The time of ultrasound before the intervention is six months and nine months later. 2- In the intervention group, Dienogest 2 mg is a daily oral dose. 3- The realized statistics is 68. 4- Displacement of consequencesAdding the secondary outcome "Uterine position" and removing it from the primary outcomes. 5-Adding the criteria (( use of gonadotropin agonist or antagonist, hormonal contraceptive in the last three months)) in the main conditions of not entering the study before randomization. 6-1- History of specific diseases (including epilepsy, gastrointestinal, cardiovascular, renal disorders) according to the person's own statement. 2- Allergy to dienogest and bromocriptine. 3- Existence of important gynecological disease or abdominal and pelvic surgery in the last 6 months.
موارد زیر اشتباه درج شده است اصلاح گردد. 1-زمان انجام سونوگرافی قبل از مداخله ،شش ماه و نه ماه بعد می باشد.
2-در گروه مداخله داینوژست 2 میلیگرم یک عدد خوراکی روزانه می باشد.
3-آمار تحقق یافته 68 می باشد.
4- جابجای پیامد ها.
5-اضافه نمودن معیار (( مصرف آگونیست یا آنتاگونیست گنادوتروپین ،کنتراسپتیو هورمونی در سه ماه اخیر)) در شرایط عمده عدم ورود به مطالعه قبل از تصادفی سازی
6-تغییر معیار ها عمده عدم ورود به مطالعه :
1-سابقه بیماری خاص (ازجمله صرع، ناراحتیهای گوارشی، قلبی-عروقی، کلیوی) بنا به اظهار خود فرد
2- آلرژی به داینوژست و بروموکریپتین
3-وجود بیماری مهم ژنیکولوژی و یا جراحی شکمی و لگنی در ۶ ماه اخیر.
موارد زیر اشتباه درج شده است اصلاح گردد. 1-زمان انجام سونوگرافی قبل از مداخله ،شش ماه و نه ماه بعد می باشد.
2-در گروه مداخله داینوژست 2 میلیگرم یک عدد خوراکی روزانه می باشد.
3-آمار تحقق یافته 68 می باشد.
4- اضافه نمودن پیامد ثانویه وضعیت نمای رحم و حذف آن از پیامدهای اولیه
5-اضافه نمودن معیار (( مصرف آگونیست یا آنتاگونیست گنادوتروپین ،کنتراسپتیو هورمونی در سه ماه اخیر)) در شرایط عمده عدم ورود به مطالعه قبل از تصادفی سازی
6-تغییر معیار ها عمده عدم ورود به مطالعه :
1-سابقه بیماری خاص (ازجمله صرع، ناراحتیهای گوارشی، قلبی-عروقی، کلیوی) بنا به اظهار خود فرد
2- آلرژی به داینوژست و بروموکریپتین
3-وجود بیماری مهم ژنیکولوژی و یا جراحی شکمی و لگنی در ۶ ماه اخیر.
موارد زیر اشتباه درج شده است اصلاح گردد. 1-زمان انجام سونوگرافی قبل از مداخله ،شش ماه و نه ماه بعد می باشد. 2-در گروه مداخله داینوژست 2 میلیگرم یک عدد خوراکی روزانه می باشد. 3-آمار تحقق یافته 68 می باشد. 4- جابجایاضافه نمودن پیامد ها.ثانویه وضعیت نمای رحم و حذف آن از پیامدهای اولیه 5-اضافه نمودن معیار (( مصرف آگونیست یا آنتاگونیست گنادوتروپین ،کنتراسپتیو هورمونی در سه ماه اخیر)) در شرایط عمده عدم ورود به مطالعه قبل از تصادفی سازی 6-تغییر معیار ها عمده عدم ورود به مطالعه : 1-سابقه بیماری خاص (ازجمله صرع، ناراحتیهای گوارشی، قلبی-عروقی، کلیوی) بنا به اظهار خود فرد 2- آلرژی به داینوژست و بروموکریپتین 3-وجود بیماری مهم ژنیکولوژی و یا جراحی شکمی و لگنی در ۶ ماه اخیر.
Primary outcomes
#1
State of uterine view
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State of uterine view
وضعیت نمای رحم
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وضعیت نمای رحم
The condition of the uterus is checked at the beginning of the study (before the start of the intervention) and 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
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The condition of the uterus is checked at the beginning of the study (before the start of the intervention) and 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
وضعیت نمای رحم در ابتدای مطالعه (قبل از شروع مداخله) و 6 و 9 ماه پس از شروع مصرف دارو بروموکریپتین واژینال و داینوژست بررسی می شود.
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وضعیت نمای رحم در ابتدای مطالعه (قبل از شروع مداخله) و 6 و 9 ماه پس از شروع مصرف دارو بروموکریپتین واژینال و داینوژست بررسی می شود.
Vaginal ultrasound
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Vaginal ultrasound
سونوگرافی واژینال
empty
سونوگرافی واژینال
Secondary outcomes
#1
empty
State of uterine view
State of uterine view
empty
وضعیت نمای رحم
وضعیت نمای رحم
empty
The condition of the uterus is checked at the beginning of the study (before the start of the intervention) and 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
The condition of the uterus is checked at the beginning of the study (before the start of the intervention) and 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
empty
وضعیت نمای رحم در ابتدای مطالعه (قبل از شروع مداخله) و 6 و 9 ماه پس از شروع مصرف دارو بروموکریپتین واژینال و داینوژست بررسی می شود.
وضعیت نمای رحم در ابتدای مطالعه (قبل از شروع مداخله) و 6 و 9 ماه پس از شروع مصرف دارو بروموکریپتین واژینال و داینوژست بررسی می شود.
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Vaginal ultrasound
Vaginal ultrasound
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سونوگرافی واژینال
سونوگرافی واژینال
Protocol summary
Study aim
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.
The following items have been entered incorrectly, please correct them.
1- The time of ultrasound before the intervention is six months and nine months later.
2- In the intervention group, Dienogest 2 mg is a daily oral dose.
3- The realized statistics is 68.
4- Adding the secondary outcome "Uterine position" and removing it from the primary outcomes.
5-Adding the criteria (( use of gonadotropin agonist or antagonist, hormonal contraceptive in the last three months)) in the main conditions of not entering the study before randomization.
6-1- History of specific diseases (including epilepsy, gastrointestinal, cardiovascular, renal disorders) according to the person's own statement.
2- Allergy to dienogest and bromocriptine.
3- Existence of important gynecological disease or abdominal and pelvic surgery in the last 6 months.
Acronym
IRCT registration information
IRCT registration number:IRCT20230407057838N1
Registration date:2023-08-21, 1402/05/30
Registration timing:retrospective
Last update:2023-12-31, 1402/10/10
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:
having a history of specific diseases (including epilepsy, gastrointestinal, cardiovascular, renal disorders) according to the person's own statement.
allergies to dienogest and bromocriptine
Presence of significant gynecological disease or abdominal and pelvic surgery in the last 6 months
- Not using gonadotropin agonist or antagonist, hormonal contraceptive in the last three 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:
68
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
Ethics committee of Iran university of Medicine Sciences
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.
2
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
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 6, and 9 months after starting the use of vaginal bromocriptine and dinogest.
Method of measurement
Vaginal ultrasound
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 1 mg, 2 tablets, daily, oral for 6 months.