Comparative evaluation of the efficacy and safety of ormeloxifene and norethisterone in dysfunctional uterine bleeding

Agarwal, Neha; Singh, Saroj; Singh, Shikha; Agarwal, Meenal; Manocha, Pallavi

doi:10.5455/2320-1770.ijrcog20130617

Cited by 15 publications

(25 citation statements)

References 12 publications

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“…Approximately 20-30% of women (among 35-50 yrs of age) seek medical help for heavy menstrual bleeding (HMB) resulting in anaemia affecting their physical, social and emotional quality of life. 1 The approach to management is to ensure general well being and improve quality of life in addition to control of the bleeding. Medical therapy is the first line of management for DUB.…”

Section: Introductionmentioning

confidence: 99%

Ormeloxifene versus Tranexamic acid in dysfunctional uterine bleeding comparative evaluation

Hymavathi

Gottipati

Prasuna

et al. 2018

Int J Reprod Contracept Obstet Gynecol

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Background: Dysfunctional Uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding (AUB). Medical therapy being the first line of management, an ideal drug should be able to block the estrogenic effects on the Endometrium without interfering with its beneficial effects on other tissues. Both Ormeloxifene - a selective estrogen receptor modulator (SERM) and Tranexamic acid-an anti fibrinolytic inhibitor is important in the treatment of DUB. The aim of this study is to assess the efficacy and safety of Ormeloxifene v/s Tranexamic acid in the treatment of DUB.Methods: This is a prospective double blind study conducted for 2 years in 200 women presenting with DUB attending to the Gynaecology outpatient department (OPD) of Narayana Medical College and Hospital, Nellore, AP, India. Two hundred women presenting with DUB were recruited into this study (after fulfilling inclusion and exclusion criteria) with informed consent and randomly divided into two equal groups (Group-A and Group-B) after obtaining college ethical committee approval.Results: The reduction in the mean pictorial blood loss assessment chart (PBAC) score with Ormeloxifene (from 278 to 97.6) was significantly more than that of Tranexamic acid (from 261 to 134.5) at six months (p <0.0001). The rise in Hemoglobin concentration (8.4g% to 11.15g% vs. 8.5 to 9.7gm%; p <0.008) and reduction in Endometrial thickness (from 10.57mm to 6.5mm v/s 9.96mm to 7.24mm p <0.0001) were also significantly more with Ormeloxifene than with Tranexamic acid. Relief from dysmenorrhoea and subjective improvement were also found to be considerable with Ormeloxifene.Conclusions: Both Ormeloxifene and Tranexamic acid can be considered for DUB treatment but Ormeloxifene is found to be superior to Tranexamic acid in various aspects.

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Section: Introductionmentioning

confidence: 99%

Ormeloxifene versus Tranexamic acid in dysfunctional uterine bleeding comparative evaluation

Hymavathi

Gottipati

Prasuna

et al. 2018

Int J Reprod Contracept Obstet Gynecol

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“…Many drugs have been recommended for treatment of DUB including antifibrinolytics, medroxyprogesterone acetate, NSAIDs, oral contraceptive pills, progestins, levo-norgestrel containing IUCD, GnRH analogues, danazol and a few studies have also recommended use of ormeloxifene. 1,3,5,11,14,15 In the present study, reduction in menorrhagia represented by decrease in post-treatment PBAC score was significantly observed in both the treatment groups, however, ormeloxifene treatment showed better results in comparison to OCP.…”

Section: Discussionmentioning

confidence: 54%

“…At the end of 6 months post treatment with ormeloxifene showed better results on reduction of ET in comparison to OCP therapy and these findings are in agreement with the earlier studies. 3,11 Though in the present study, the level of satisfaction among the patients was observed in both the treatment groups, however ormeloxifene therapy was reported to be comparatively more effective. The side effects were minimal and tolerable in both the groups indicated the safety and tolerance of both the drugs among all the patients.…”

mentioning

confidence: 63%

“…[8][9][10] It does not produce spotting or breakthrough bleeding. 11 The ideal therapy in peri-menopausal women is one that has no stimulatory effects on endometrium, prevents bone loss, no risk of breast cancer, positive effect on lipids and cardiovascular system and no adverse effect like abnormal menstrual bleeding. Ormeloxifene satisfy all these criteria.…”

Section: Introductionmentioning

confidence: 99%

“…3,7,11,[15][16][17] The mean endometrial thickness was also significantly reduced in both the study groups following therapy. At the end of 6 months post treatment with ormeloxifene showed better results on reduction of ET in comparison to OCP therapy and these findings are in agreement with the earlier studies.…”

mentioning

confidence: 99%

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Efficacy of ormeloxifene in comparison to oral contraceptive pills in medical management of dysfunctional uterine bleeding

2016

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Background: Menstrual disorders are the most common gynecological condition resulting in hospital referrals. Dysfunctional Uterine Bleeding is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause. Among women in reproductive age, one in 20 consults her general practitioner each year with menorrhagia. This condition can be managed both medically and surgically. Pharmacological treatment options available for DUB are combined oral contraceptive pills, progestogens, danazol, gonadotrophin releasing hormone (GnRH) agonists, prostaglandin synthetase inhibitor, anti-fibrinolytics and ethamsylate. Role of ormeloxifene in dysfunctional uterine bleeding (DUB) is still in an exploring level. The purpose of the study was to evaluate the efficacy of ormeloxifene in the treatment of DUB and compare the effects of ormeloxifene with combined oral contraceptive pills for the control of DUB. Methods: Sixty women presenting with DUB were randomly allocated to 2 equal groups, Group A were given ormeloxifene tablet @ 60 mg twice a week for 12 weeks, followed by 60 mg once a week for 12 weeks. Group B were given low dose combined oral contraceptive pills (OCP) containing 30 microgram ethinyloestradiol and 150 microgram levonorgestrel from day 1 to day 21st of the menstrual cycle for 6 cycles. The various parameters studied were reduction in menstrual blood loss which was measured by fall in pictorial blood loss assessment chart (PBAC) score, rise in haemoglobin (Hb) level and reduction in endometrial thickness, any drug side effects, compliance with the drug, dosage schedule and effect on quality of life after each month and at the end of trial period of 6 months. Patient"s level of satisfaction was assessed by improvement in Hb concentration, sense of wellbeing as well as overall general health, quality of life, sexual life and comfort with the continuation of the same drug. Results: Mean blood loss (PBAC score) following treatment showed significant reduction in both the groups, however this reduction was comparatively high in ormeloxifene treated group. The various parameters to assess the subjective and clinical improvement at the end 3 and 6 months post treatment showed significant improvement in both the treatment groups; however ormeloxifene group showed significantly better improvement in comparison to OCP group. Mean endometrial thickness also showed reduction in both the groups but more significant reduction was observed in ormeloxifene group as compared to OCP group following 6 months of treatment. Symptomatic relief and subjective feelings in relation to improvement of menstrual abnormalities, any undesirable side effects, about dosage compliance and any thought of discontinuing the drug by the patients indicated excellent control of menorrhagia in both the study group, which accounted for 86.66% in ormeloxifene group and 80% of individuals in OCP group. Conclusions: ORM is effective in control of DUB and can be used as an alternative to OCP for treatment of DUB with possibly ...

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A Comparative Study on Efficacy of Norethisterone and Medroxyprogestrone in the Management of Dysfunctional Uterine Bleeding: A Prospective Observational Study

Kader¹,

Karthikeyan²,

2023

Biosci., Biotech. Res. Asia

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Dysfunctional uterine bleeding (DUB) is defined as bleeding from the uterine corpus that is abnormal in regularity, volume, frequency, or duration and occurs in the absence of pregnancy. Methylprogesterone (MPA) and Norethisterone (NE) are a sort of female hormone (progestin).To cure dysfunctional uterine bleeding, this study sought to determine how MPA and NE worked. Materials and Procedures Over three months, a prospective observational study was conducted at a hospital in Palakkad. The usefulness of MPA and NE is analyzed by using the PBAC score method. Using Microsoft Excel 2007, the cases were entered, and descriptive statistical analysis was then performed. Results and Discussion There were 71 respondents in this study, with ages ranging from 18 to 35 and older. 32 of the 71 people received MPA, whereas 39 of them acquired NE. DUB was much more prevalent in women over 35 (NE-56.4% and MPA-75%). DUB is usually seen in overweight individuals (NE: 56.4%; MPA: 50.). The PBAC score dropped after both medications were administered. Norethisterone is more effective than either of the drugs, as per this study.

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Comparative evaluation of the efficacy and safety of ormeloxifene and norethisterone in dysfunctional uterine bleeding

Cited by 15 publications

References 12 publications

Ormeloxifene versus Tranexamic acid in dysfunctional uterine bleeding comparative evaluation

Ormeloxifene versus Tranexamic acid in dysfunctional uterine bleeding comparative evaluation

Efficacy of ormeloxifene in comparison to oral contraceptive pills in medical management of dysfunctional uterine bleeding

A Comparative Study on Efficacy of Norethisterone and Medroxyprogestrone in the Management of Dysfunctional Uterine Bleeding: A Prospective Observational Study

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