Sample Essay

This will be a single centre study conducted at Central Hospital, Detroit. It will be a single-blinded, prospective, randomised controlled trial. All ethical issues will be considered and approval from research ethics committee will be taken. The purpose of the research and all the procedures will be explained to the study participants and written informed consent will be obtained.

Randomization will be done with the help of precoded numbers sealed in envelopes which will be opened by the research nurse at the time of treatment allocation to the patients. Participants will be randomly divided into two groups: Group 1- intravaginal estrogen and Group 2- oral estrogen. Treatment will be initiated on the initial visit of the patients after proper assessment. The consultant assessing the patients will be blinded and will not be aware of the treatment group of the patients. After the initial assessment, the patients will be assessed at regular intervals: 1 month, 3 months, 6 months and 1 year.

A number of subjective and objective outcome measures will be used to assess the benefit and adverse effects of estrogen in patients in both the groups. Subjective assessment will include the symptoms of the patient (vaginal dryness, itching, dyspareunia, etc) and clinical appearance of vaginal surface (pale, dry, fragile, etc). Objective assessment will include vaginal pH and cytology. The safety of the treatment will be assessed by appearance of systemic or local adverse effects, endometrial thickness, endometrial biopsy, progesterone challenge test and breast tenderness.

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Essay: Methodology to Study Effects of Estrogen In Patients
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