Andrew Moses, (2022) Efficacy of Mirena Versus Ormeloxifene in Management of Abnormal Uterine Bleeding (AUB): A Randomized Control Trial in a Tertiary Centre in South India. Masters thesis, Christian Medical College, Vellore.
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Abstract
INTRODUCTION: Abnormal uterine bleeding refers to irregularities in the menstrual cycle; these include abnormalities in the regularity, frequency, duration, or volume of flow. Up to one-third of women experience some form of abnormal uterine bleeding in their life. AUB has been classified by the International Federation of Gynaecology and Obstetrics (FIGO) based on the cause of bleeding in the PALM-COEIN classification. There are structural causes for AUB which usually warrant surgical correction, while the non-structural causes are amenable to medical management. Although many drugs have been used in the management of AUB, there is no current gold standard of therapy. Combined oral contraceptive pills, Progestins, antifibrinolytics, gonadotropin-releasing hormone, and Levonorgestrel (LNG) intrauterine device are all under use, with each drug having its advantage and disadvantages. OBJECTIVES: The primary objective was to compare the efficacy of Ormeloxifene and Mirena. The secondary objectives were to compare the effect on haemoglobin levels, to assess the incidence of unscheduled bleeding, to note the side-effect profile of each drug, to assess the need for surgery or change o therapy, and to assess the success of treatment with each drug. DESIGN: This was a hospital based, prospective, open-labelled, phase three RCT. SETTING: The study was conducted in the Outpatient clinics of the department of Obstetrics and Gynaecology, Christian Medical College, Vellore, which is a tertiary hospital. PARTICIPANTS: Patients attending the Obstetrics and Gynaecology department, who were diagnosed with AUB and having a PBAC score of >100 and had completed family/ not desirous of conception were recruited for the study, if they did not fit the exclusion criteria. INTERVENTIONS: The intervention agent was Ormeloxifene 60mg tablet taken per oral to be taken twice a week for 12 weeks followed by Ormeloxifene 60mg tablet taken per oral once a week for 12 weeks. The comparator which was Mirena, placed in an OPD setting. MAIN OUTCOME MEASUREMENT: The main outcome was a reduction in the mean PBAC scores at the end of 6 months of therapy. RESULTS: The reduction in the mean PBAC scores in the Ormeloxifene group was within 10% of the reduction in PBAC scores in the Mirena group. There was no statistically significant reduction in the blood loss at the time of analysis, but this could be subject to change after completion of the study. CONCLUSIONS: Mirena and Ormeloxifene both showed good reduction in menstrual blood loss. Both drugs are associated with amenorrhoea; Ormeloxifene could be used as a first line agent in management of AUB, especially in the peri-menopausal age group.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 221916402 |
| Uncontrolled Keywords: | Levonorgestrel Intrauterine system, Mirena, Ormeloxifene, Abnormal uterine bleeding. |
| Subjects: | MEDICAL > Obstetrics and Gynaecology > MEDICAL > Obstetrics and Gynaecology |
| Depositing User: | Subramani R |
| Date Deposited: | 18 May 2021 16:29 |
| Last Modified: | 10 Dec 2023 08:07 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/17034 |
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