Protocol summary
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Study aim
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Comparison of the clinical effects and side effects of oral progesterone with vaginal progesterone for treatment of the patients with endometrial hyperplasia associated with abnormal uterine bleeding (AUB)
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Design
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A randomized clinical trial, with parallel groups and sample size of 60 (30 in each group)
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Settings and conduct
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Women with endometrial hyperplasia and uterine bleeding attending to Arash Women's Hospital will be included after obtaining written informed consent. A vaginal ultrasound scan will be performed for and based on ultrasound and clinical signs, an endometrial sample will be collected by curettage or pipelle. Then, subjects without atypia would be included and randomly assigned into two groups. One group will receive oral and the other group will receive vaginal progesterone. Endometrial thickness and biopsy will be re-examined after 3 months. Blood pressure, lipid and glucose profiles, liver function tests, CBC, and participants' weight will be assessed before and three months after the intervention begins.
Treatment complications including headache, mastalgia, bloating, and ..., as well as the number of pads used, menstrual delay, period length, Irregular bleeding, menstrual cycles, and clot disposal will be monitored.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Aged 25-70 years old
Endometrial hyperplasia without atypia associated with AUB
Exclusion criteria:
Malignancy
Genital infection
Contraindication for progesterone use
History of hormone therapy during the last 6 months
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Intervention groups
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Group 1: daily use of 100 mg Actogest vaginal tablets (Actogest company) from 10th to 25th day of the menstrual cycle for 3 months
Group 2: Routine treatment with daily 10 mg Medroxyprogesterone oral tablets from 10th to 25th day of the menstrual cycle for 3 months
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Main outcome variables
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Endometrial thickness, Uterine bleeding, Side effects
General information
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Reason for update
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Due to the Covid-19 pandemic, the sampling was prolonged.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140820018866N8
Registration date:
2019-11-10, 1398/08/19
Registration timing:
prospective
Last update:
2022-12-28, 1401/10/07
Update count:
1
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Registration date
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2019-11-10, 1398/08/19
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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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2019-11-22, 1398/09/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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Actual recruitment start date
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2019-11-24, 1398/09/03
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Actual recruitment end date
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2022-05-13, 1401/02/23
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Trial completion date
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2022-09-21, 1401/06/30
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Scientific title
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A Comparative Study on the Clinical Effects and Side Effects of Oral Progesterone versus Vaginal Progesterone for the Treatment of Endometrial Hyperplasia in Patients with Abnormal Uterine Bleeding (AUB)
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Public title
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Oral versus vaginal progesterone for treatment of endometrial hypreplasia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged between 25 and 70 years old
Endometrial hyperplasia without atypia associated with abnormal uterine bleeding
Exclusion criteria:
Malignancy
Genital infection
Contraindication for progesterone use such as Haptic disorders or tumor, thromboembolism, etc.
History of hormone therapy during last 6 months
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Age
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From 25 years old to 70 years old
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Gender
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Female
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Phase
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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:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization method used in this study will be the block randomization method developed by the statistics expert by using the STATA software in a randomization list format. Then, according to the randomization list, the type of intervention for each individual will be written on paper, and the paper will be put in a sealed envelope. Envelopes will be numbered according to the randomization list. The physician will examine the patient's eligibility, and if the patient is eligible, she will tell the hospital research assistant. The research assistant will then provide the sealed envelope to the physician, and the physician will begin the intervention according to the contents of the envelope.
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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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2019-08-11, 1398/05/20
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1398.398
Health conditions studied
1
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Description of health condition studied
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Endometrial hyperplasia
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ICD-10 code
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N85.0
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ICD-10 code description
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Endometrial hyperplasia
Primary outcomes
1
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Description
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Pathological changes in endometrial sample
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Timepoint
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At baseline (before the interventions began) and three months after interventions began
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Method of measurement
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Evaluation of endometrial tissue sample by pathologist for evaluation of cellular changes
2
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Description
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Vaginal bleeding
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Timepoint
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At baseline (before the interventions began) and three months after interventions began
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Method of measurement
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Number of pads used
3
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Description
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Hemoglobin level
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Timepoint
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At baseline (before the interventions began) and three months after interventions began
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Method of measurement
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A complete blood count (CBC)
Secondary outcomes
1
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Description
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Clinical side effects of the drug
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Timepoint
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At baseline (before the interventions began) and three months after interventions began
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Method of measurement
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Recording clinical side effects including headache, bruising, bloating, nausea and vomiting, weight gain, joint and muscle pain, gastric pain, vaginal itching, uterine pain, as well as delayed menstruation, irregular bleeding, and clotting in a questionnaire.
2
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Description
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Paraclinical side effects of the drug
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Timepoint
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At baseline (before the interventions began) and three months after interventions began
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Method of measurement
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Measurement of blood pressure, lipid and glucose profiles, liver function tests and CBC
Intervention groups
1
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Description
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Intervention group: daily use of 100 mg Actogest vaginal tablets (Atipharmed Pharmaceutical Company) from 10th to 25th day of the menstrual cycle for 3 months
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Category
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Treatment - Drugs
2
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Description
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Control group: Routine treatment with daily 10 mg Medroxyprogesterone oral tablets from 10th to 25th day of the menstrual cycle for 3 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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Tehran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available