Comparison of medroxyprogesterone acetate and dydrogesterone effects on treatment of patients with abnormal vaginal bleeding

main aim of this study is comparison of medroxyprogesterone acetate and dydrogesterone effects on treatment of patients with abnormal vaginal bleeding

The sample size in this study is 176 people who will be randomly divided into two groups receiving medroxyprogesterone acetate or dyrogesterone. after investigating the Inclusion/Exclusion Criteria and obtaining informed consent. Block randomization method is designed by fellow epidemiologist using stata version 13 software.

This is a double-blind clinical trial, which will be conducted on 176 women with abnormal vaginal bleeding who are referred to the Arash Hospital's Gynecology Clinic. After obtaining written consent, the participants will be randomly divided into two groups. The first group is treated with medroxyprogesterone acetate tablets (5 mg every 12 hours from the 14th day of the menstrual cycle for 10 days) and the second group will be treated with drogesterone tablets (10 mg every 12 hours from the 14th day of the menstrual cycle for 10 days). The treatment cycle will last for three consecutive months. Complications reported by the patient, drug tolerance, returning to normal cycles (as defined) will be evaluated and ultrasound control will be requested at the end of the sixth month.

Patients with abnormal vaginal bleeding, endometrial thickness greater than 5 mm and no contraindications to taking Progesterone enter the study and patients with endocrine disorders and anatomical problems are excluded from study.

intervention Group 1: oral medroxyprogesterone acetate tablets; Intervention Group 2: drogesterone tablets

Vaginal bleeding; Endometrial thickness; "drugs side effects"

Tehran University of Medical Science

Our sample size is 176 people, with 88 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 4.

The random allocation list will solely available to the epidemiologist. 176 cards containing sequences of treatments will be written and be placed inside sealed envelopes. A10-digit random code, as the patient’s identification number, will be provided for each packet. When the physician announces the eligibility of a patient, the methodologist will provide the physician with the envelope. None of the patients should be aware of the type and process of treatment. Also, the person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed.