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IRCT20140820018866N8 IRCT 2019-11-10 Tehran University of Medical Sciences Oral versus vaginal progesterone for treatment of endometrial hypreplasia 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) 2019-11-22 anticipated 60 Complete https://irct.ir/trial/41581 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 Endometrial hyperplasia. Intervention 1: 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. Intervention 2: Control group: Routine treatment with daily 10 mg Medroxyprogesterone oral tablets from 10th to 25th day of the menstrual cycle for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The research team has not yet decided on how to publish the data.
public Dr. Zahra Molla amin
Arash women hospital, Tehranpars, Resalat highway
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 asalamini64@gmail.com Arash women hospital scientific Dr. Afsaneh Tehranian
No. 162 AŁŽlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 afsanehtehranian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Aged between 25 and 70 years old Endometrial hyperplasia without atypia associated with abnormal uterine bleeding 25 years 70 years Female Malignancy Genital infection Contraindication for progesterone use such as Haptic disorders or tumor, thromboembolism, etc. History of hormone therapy during last 6 months N85.0 Endometrial hyperplasia Treatment - Drugs Treatment - Drugs 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 Control group: Routine treatment with daily 10 mg Medroxyprogesterone oral tablets from 10th to 25th day of the menstrual cycle for 3 months 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. Vaginal bleeding. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: Number of pads used. Hemoglobin level. Timepoint: At baseline (before the interventions began) and three months after interventions began. Method of measurement: A complete blood count (CBC). 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. 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. Tehran University of Medical Sciences Approved 2019-08-11 Ethics committee of Tehran University of Medical Science Tehran University of Medical Science, Qods Street, Keshavarz Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)