Protocol summary
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Study aim
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Determining the effect of treatment, vaginal bromocriptine and dienogest on the ultrasound image and the amount of bleeding and pain caused by adenomyosis.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Adenomyosis; menstrual pain; amount of menstrual bleeding, vaginal bromocriptine; Dynogest, ultrasound changes
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-08-21, 1402/05/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-23, 1400/07/01
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Expected recruitment end date
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2023-03-16, 1401/12/25
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Actual recruitment start date
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2021-10-02, 1400/07/10
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Actual recruitment end date
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2022-08-23, 1401/06/01
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Trial completion date
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2023-03-18, 1401/12/27
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Scientific title
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Comparison of the therapeutic effect of vaginal bromocriptine and dienogest on ultrasound and bleeding and pain due to adenomyosis
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Public title
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"vaginal bromocriptine" and" dienogest" on the treatment of adenomyosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 35 years old to 50 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
68
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-18, 1400/06/27
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Ethics committee reference number
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IR.IUMS.FMD.REC.1400.361
Health conditions studied
1
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Description of health condition studied
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Adenomyosis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain
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Timepoint
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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.
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Method of measurement
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"Visual pain measurement tool" questionnaires are used to evaluate pain.
2
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Description
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Blood loss
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Timepoint
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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.
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Method of measurement
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A "visual chart of blood loss" is used to evaluate changes in menstrual symptoms.
Secondary outcomes
1
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Description
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State of uterine view
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Timepoint
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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.
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Method of measurement
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Vaginal ultrasound
Intervention groups
1
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Description
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Intervention group 1: Bromocriptine (Iran Hormone Company) in the amount of 2.5 mg, 2 tablets, daily, vaginally for 6 months.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Dienogest (Iran Hormone Company) at the rate of 1 mg, 2 tablets, daily, oral for 6 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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"There is no further information".
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available