Skip to content

Compare the effect of the drug Letrozole and Megestrolto treat abnormal uterine bleeding

Letrozole versus Megestrol acetate for treatment of simple endometrial hyperplasia without Atypia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015031011504N5
Enrollment
50
Registered
2015-12-12
Start date
2015-06-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

simple hyperplasia. No inflammatory disorders of female genital trac

Interventions

Intervention 1: He first group will be prescribed 40 milligram of Megestrol acetate (40 milligram BRENDOCARE tablet, made by Aburaihan pharmaceutical co. Iran) for two weeks in each month (A 40 millig
Treatment - Drugs
He first group will be prescribed 40 milligram of Megestrol acetate (40 milligram BRENDOCARE tablet, made by Aburaihan pharmaceutical co. Iran) for two weeks in each month (A 40 milligram tablet per d
The second group will be prescribed 2.5 milligram of Letrozole (2.5 milligram Letrax tablet, made by Aburaihan pharmaceutical co. Iran), for two months, A tablet per day. After the end of treatment, a

Sponsors

Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
44 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age 44 to 50 years, Having abnormal uterine Hemorrhage, simple hyperplasia without Atypia present in the endometrial biopsy, agreement to take part in the study, abnormal thickening of the endometrium (more than 12millimeterin reproductive age sand the pre- menopausal or the presence of endometrium 5 to 12millimeters in reproductive ages and pre- menopausal along with abnormal bleeding continuation despite medical treatment) intrans vaginal ultrasound(first evaluation via basic trans-vaginal ultrasound will be done for all research units by the sonography and in case of abnormal endometrium thickness (more than12millimeters), these people will inter the study; Exclusion criteria: Performing hormone therapy during the last 6 months, wanting to get pregnantfor at least 3 months from now, focal endometrial lesions such as Leiomyoma, having Atypi color complexly perplasia, flushing symptoms, Sleep Disorders, mood changes during the last 3 months, Breast-feeding, Having congenital uterine disorders, Hypothyroidism, Hypertension, history of vascular disease or clotting disorders, sensitivity to Progestin’s.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Endometrial hyperplasia without Atypia simple cytologic. Timepoint: Before and after the intervening. Method of measurement: Trans-vaginal ultra sound and endometrial biopsy basis.;Abnormal uterine bleeding. Timepoint: Before and after the interference(the twentieth to twenty fourth day of menstrual cycle). Method of measurement: Trans-vaginal ultra sound and endometrial biopsy basis.;Premenopausal. Timepoint: Before and after the interference(20 to 24menstrual cycles). Method of measurement: Measuring the serum level of follicle-stimulating hormone.

Secondary

MeasureTime frame
Estradiol. Timepoint: Before and after the intervention. Method of measurement: Serum levels of Estradiol.;Endometrial thickness. Timepoint: Before and after the intervening. Method of measurement: The wall thickness of the Endometrial based on ultrasound.;Side effects of taking Letrozole and Megestrol acetate. Timepoint: Once per month. Method of measurement: Genera sensitivity, itching, hives and monthly sonography.;Triglyceride. Timepoint: Before and after the intervention. Method of measurement: Blood levels of triglycerides.;Cholesterol. Timepoint: Before and after the intervention. Method of measurement: Blood levels of cholesterol.;Menstrual status. Timepoint: Before and after the intervention. Method of measurement: Oligomenorrhea, Polymenorrhea ,normal.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Niaz Nik Khah

Semnan University of Medical Sciences

niaz_nik@yahoo.com+98 23 3346 1433

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 10, 2026