Oral versus vaginal progesterone for treatment of endometrial hypreplasia

Phase 3

Conditions: Endometrial hyperplasia.
Endometrial hyperplasia
N85.0

Registration Number: IRCT20140820018866N8

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Aged between 25 and 70 years old
Endometrial hyperplasia without atypia associated with abnormal uterine bleeding

Exclusion Criteria

Malignancy
Genital infection
Contraindication for progesterone use such as Haptic disorders or tumor, thromboembolism, etc.
History of hormone therapy during last 6 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.