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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General information
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80
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2019-11-24, 1398/09/03
2019-11-24 00:00:00
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2022-05-13, 1401/02/23
2022-05-13 00:00:00
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2022-09-21, 1401/06/30
2022-09-21 00:00:00
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Due to the Covid-19 pandemic, the sampling was prolonged.
Due to the Covid-19 pandemic, the sampling was prolonged.
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به دلیل پاندمی کرونا نمونه گیری طولانی شد.
به دلیل پاندمی کرونا نمونه گیری طولانی شد.
Protocol summary
Study aim
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)
Design
A randomized clinical trial, with parallel groups and sample size of 60 (30 in each group)
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Endometrial thickness, Uterine bleeding, Side effects
General information
Reason for update
Due to the Covid-19 pandemic, the sampling was prolonged.
Acronym
IRCT registration information
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
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Afsaneh Tehranian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
afsanehtehranian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2019-11-24, 1398/09/03
Actual recruitment end date
2022-05-13, 1401/02/23
Trial completion date
2022-09-21, 1401/06/30
Scientific title
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)
Public title
Oral versus vaginal progesterone for treatment of endometrial hypreplasia
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 25 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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 Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-08-11, 1398/05/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.398
Health conditions studied
1
Description of health condition studied
Endometrial hyperplasia
ICD-10 code
N85.0
ICD-10 code description
Endometrial hyperplasia
Primary outcomes
1
Description
Pathological changes in endometrial sample
Timepoint
At baseline (before the interventions began) and three months after interventions began
Method of measurement
Evaluation of endometrial tissue sample by pathologist for evaluation of cellular changes
2
Description
Vaginal bleeding
Timepoint
At baseline (before the interventions began) and three months after interventions began
Method of measurement
Number of pads used
3
Description
Hemoglobin level
Timepoint
At baseline (before the interventions began) and three months after interventions began
Method of measurement
A complete blood count (CBC)
Secondary outcomes
1
Description
Clinical side effects of the drug
Timepoint
At baseline (before the interventions began) and three months after interventions began
Method of measurement
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
Description
Paraclinical side effects of the drug
Timepoint
At baseline (before the interventions began) and three months after interventions began
Method of measurement
Measurement of blood pressure, lipid and glucose profiles, liver function tests and CBC
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Control group: Routine treatment with daily 10 mg Medroxyprogesterone oral tablets from 10th to 25th day of the menstrual cycle for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr Afsaneh Tehranian
Street address
No. 162 Aَlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
afsanehtehranian@yahoo.com
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
6th floor, Central University, Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8838 8988
Fax
+98 21 8838 8988
Email
resdeputy@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arash women hospital
Full name of responsible person
Dr. Zahra Molla amin
Position
Resident of Obstetrics and gynaecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash women hospital, Tehranpars, Resalat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
asalamini64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Afsaneh Tehranian
Position
Assistant Professor, Department of obstetrics and gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 Aَlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
afsanehtehranian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afsaneh Tehranian
Position
Assistant Professor, Department of obstetrics and gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 Aَlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3293
Email
afsanehtehranian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available