Evaluation of the Aromatase inhibitors in combination with oral contraceptive pills versus GnRH agonist on uterine myoma
Design
Phase 3 randomized clinical trial with parallel groups
Settings and conduct
This study will be conducted at Arash Women's Hospital on patients with uterine myomas. Participants will randomly be assigned into two groups; group 1 (Letrozole + OCP) and group 2 (Decapeptide Ampule). Once before and then once three months after the start of the intervention, information about demographic data and medical history will be collected through questionnaire. Pelvic pain and dysmenorrhea will be assessed by VAS monthly. Participants will be requested to record the amount of their menstrual bleeding and hot flashes. For all patients, serum tests will be measured. A radiologist will assess the uterine size and number, size, type, and the location of the fibroids by ultrasound. The degree of satisfaction with the treatment will be determined by a researcher-made questionnaire based on a Likert scale and the side effects of both treatments will be recorded.
Participants/Inclusion and exclusion criteria
Women aged 20 to 50 years, with at least 1 and a maximum of 5 uterine fibromas, with a size of more than 2 and less than 10 cm, will be included in the study if they have no malignancies or serious underlying diseases, and they do not need myomectomy.
Intervention groups
Group 1: Letrozole tablets + LD
Group two: decapeptyl ampules
Main outcome variables
Vaginal Bleeding; Hemoglobin; Pelvic Pain; Myomas Size; Uterine Size; Number of Fibromas; Dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140820018866N7
Registration date:2019-06-12, 1398/03/22
Registration timing:prospective
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
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
2019-08-23, 1398/06/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aromatase inhibitors in combination with oral contraceptive pills versus GnRH agonist on the treatment of uterine myoma
Public title
Effect of Aromatase inhibitors combination with oral contraceptive pills versus GnRH agonist on uterine myoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of at least one uterine myoma with a size of 2 centimeters (cm) or larger in ultrasound
aged between 20 and 45 years old
Exclusion criteria:
Receiving other therapeutic strategies for treatment of the myoma
Ovarian cyst or neoplasm
Size of largest myoma larger than 10 cm
More than 5 myomas
Endometrial or cervical pathology
exposure to hormonal agents in last month before the trial began
Hepatic, cardiovascular and Renal diseases, peptic ulcer, malignancy, and other serious medical conditions
Pregnancy or lactation
Indication or tendency for surgical intervention
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The considered sample size is 42, with 21 participant in each
group. Block randomization method will be designed by using "www.sealedenvelope.com".
The size of blocks considered is 6. The random allocation
list for patients will be solely available to the epidemiologist. To hide the random allocation process, 42 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the methodologist will provide 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
Keshavarz Boulevard, Qods Street, Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.681
Health conditions studied
1
Description of health condition studied
Uterine Myoma
ICD-10 code
D25
ICD-10 code description
Leiomyoma of uterus
Primary outcomes
1
Description
Average vaginal bleeding
Timepoint
Once before the intervention began, then 1, 2 , and 3 months after the intervention began
Method of measurement
pictorial blood assessment chart
2
Description
Hemoglobin
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
3
Description
Pelvic Pain
Timepoint
Once before and once three months after the intervention began
Method of measurement
Visual Analog Scale (VAS)
4
Description
Myoma Size
Timepoint
Once before and once three months after the intervention began
Method of measurement
Ultrasound
5
Description
Uterine Size
Timepoint
Once before and once three months after the intervention began
Method of measurement
Ultrasound
6
Description
Number of Fibroids
Timepoint
Once before and once three months after the intervention began
Method of measurement
Ultrasound
7
Description
Dysmenorrhea
Timepoint
Once before the intervention began, then 1, 2 , and 3 months after the intervention began
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Follicle Stimulating Hormone (FSH) Level
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
2
Description
Luteinizing hormone (LH) Level
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
3
Description
Bone Marrow Density (BMD)
Timepoint
Once before and once three months after the intervention began
Method of measurement
Dual Energy X-ray Absorptiometry
4
Description
Estradiol (E2) Hormone Level
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
5
Description
Progesterone Hormone Level
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
6
Description
Testosterone Hormone Level
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
7
Description
Hot-flash
Timepoint
Daily
Method of measurement
Hot Flashes Diary
8
Description
Vitamin D3 Level
Timepoint
Once before and once three months after the intervention began
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group 1: Will receive one Letrozole 2.5 mg oral tablet plus one LD oral tablet per day, for a period of three months.
Category
Treatment - Drugs
2
Description
Intervention group 2: Will receive one decapeptyl 3.75 mg (made in France) IM injection every month, for three 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Niloofar Sadeghizadeh
Position
Gynecology Resident
Latest degree
Specialist
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 7771 9922
Email
niloofar.sz@gmail.com
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
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 7771 9922
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
Dr Niloufar Sadeghizadeh
Position
Gynecology Resident
Latest degree
Specialist
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 7771 9922
Fax
+98 21 7788 3196
Email
niloofar.sz@gmail.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
No - There is not 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