scholarly journals Comparison of safety and efficacy of Ormeloxifene and Norethisterone acetate in the treatment of heavy menstrual bleeding

Author(s):  
Sunil Kumar Juneja ◽  
Pooja Tandon ◽  
Gagandeep Kaur

Background: Menorrhagia (menstrual blood loss more than 80% per cycle) affects 10-33% of women at some stage of their lives. Medical management is the first line of therapy for menorrhagia (heavy menstrual bleeding: HMB). Progestins have been found to be very effective in the management of heavy menstrual bleeding especially during acute episodes, norethisterone acetate being widely used for the same. Ormeloxifene is a new drug with promising results in managing HMB. The study was undertaken to compare the efficacy, safety and acceptability of Ormeloxifene /Norethisterone acetate in the medical management of heavy menstrual bleeding.Methods: This was a retrospective study conducted from January 2016 till December 2018 in which 98 women of reproductive age group presented with abnormal uterine bleeding without any organic, systematic and iatrogenic causes. The patients were divided into 2 groups. Those wanting contraception along with control of HMB were assigned to Group O and given Ormeloxifene and others were given norethisterone (Group N). The primary outcomes measured were menstrual blood loss assessed subjectively by patients and ultrasonography for endometrial thickness. The secondary outcomes measured were acceptability and side effects of Ormeloxifene and norethisterone.Results: There is a significant reduction in menstrual blood loss as evidenced by the history of patients recorded on follow up and there was a significant reduction in the endometrial thickness as evidenced on follow up scan at the end of 3-4 months. no major side effects were observed with both the drugs.Conclusions: Ormeloxifene in comparison to norethisterone acetate with its effectiveness, significant results, convenient dosages schedule and no major side effects is an effective and safe alternative medical management of HMB.

2010 ◽  
Vol 26 (11) ◽  
pp. 2673-2678 ◽  
Author(s):  
Andrea S. Lukes ◽  
Ken Muse ◽  
Holly E. Richter ◽  
Keith A. Moore ◽  
Donald L. Patrick

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4215-4215
Author(s):  
Wenting Wang ◽  
Tran Bourgeois ◽  
Jennifer Klima ◽  
Elise D. Berlan ◽  
Anastasia N. Fischer ◽  
...  

Abstract Abstract 4215 Introduction Adolescent females are one of two pediatric populations at greatest risk for iron deficiency. An important risk factor for iron deficiency in adolescent females is excessive menstrual blood loss. Due in part to changes in circadian rhythms and poor sleep hygiene, fatigue is also a pervasive problem in adolescence, and may be exacerbated by iron deficiency secondary to menorrhagia. Clinical trials have shown that non-anemic adult women with low serum ferritin (≤15„30 ng/ml) and unexplained fatigue demonstrate improvement in fatigue with iron supplementation. Similar studies have not been performed in women <18 years of age. Our primary objective was to define baseline ferritin values and fatigue symptoms in a population of young females with a history of heavy menstrual bleeding. Methods The study population included 11,Ÿ17 year old females presenting to an Adolescent Gynecology Clinic or Menorrhagia Clinic for initial evaluation or follow-up of heavy menstrual bleeding. To mirror our clinical practice, the study population included patients who did and did not take iron supplements, as well as those who did and did not use hormonal contraception. To evaluate the degree and effects of menstrual blood loss, we utilized the Ruta Menorraghia Scale (RMS), a subjective measurement of menstrual blood loss and health-related quality of life. Possible responses to each multiple choice question were assigned ordinal scores to produce a total menorrhagia severity score (MSS). We investigated symptoms of fatigue using the Fatigue Severity Scale (FSS), a Likert scale measurement of fatigue's effects, symptoms, and severity (possible responses range from 1 to 7). Hemoglobin and ferritin levels were obtained by venipuncture after the completion of survey instruments. A control population of 12,Ÿ17 year old menstruating females was recruited from a Sports Medicine clinic. These patients completed the RMS and FSS instruments but did not undergo venipuncture. We compared FSS and MSS between the two populations using the Kruskal Wallis test. We evaluated possible predictors of ferritin level (age, body mass index, fatigue scores, and MSS) using generalized linear models. Results A total of 31 adolescents diagnosed with heavy menstrual bleeding and 37 healthy adolescents completed the study. Mean MSS was 39.3 (±17.4) in those with a history of heavy menstrual bleeding, compared to 17.9 (±10.0) in controls (p<.0001). When completing the menorrhagia scale, over two-thirds (71%) of adolescents with heavy menstrual bleeding reported that menses mildly to moderately affected their ability to participate in physical education class or sports, compared to 27% of controls. Thirteen (41.9%) of those with heavy bleeding reported missing at least one day of school with each menses, compared to 8.1% of controls. Mean fatigue score was 4.2 (±1.5) in patients with heavy menstrual bleeding, similar to values reported in adults with sleep-wake disorders. In contrast, the mean fatigue score was 2.98 (±1.1, p=.001) in the control population, similar to values reported in normal healthy adults. Twenty-five of 31 (80.6%) adolescents with heavy menstrual bleeding had ferritin levels ≤30 ng/ml, and ten (32.2%) had ferritin levels ≤15 ng/ml. Our generalized linear models did not identify any significant univariate relationships between ferritin levels and patient age, body mass index, fatigue score, or menorrhagia score. This finding may be due to our small sample size, or the narrow range of ferritin levels in our study population (87% had a ferritin level <40 ng/ml). Discussion Iron deficiency and symptoms of fatigue were common findings in a small population of young women with heavy menstrual bleeding. Fatigue severity scores were significantly higher in our study population as compared to healthy controls. Larger studies are needed to delineate the relationship between menstrual blood loss, fatigue, and ferritin values in adolescents, in order to plan for future intervention trials of iron supplementation. We also identified a high frequency of physical activity limitations and school absence in young women with heavy menstrual bleeding, highlighting the importance of including these types of patient-reported outcomes in the design of clinical trials for this patient population. Disclosures: No relevant conflicts of interest to declare.


2017 ◽  
pp. 115-117
Author(s):  
V.A. Benyuk ◽  
◽  
V.V. Kurochka ◽  
S.V. Benyuk ◽  
D.M. Altibaeva ◽  
...  

The objective: to study the effect of hormone therapy on menstrual function of women with adenomyosis in combination with endometrial hyperplasia. Patients and methods. We evaluated the effects of hormone therapy in 160 women of reproductive age with adenomyosis in combination with endometrial hyperplasia: I group – 60 women used the progestogen (6 months); II – 60 women, took an agonist of gonadotropin-releasing-hormone – а-GnRH) (6 months), III – 40 women who received the complex therapy including а-GnRH during the first 6 months and immunomodulator intramuscularly every other day No. 20, with subsequent use of tablets of 0.15 g of 1 times a week (course - 6 months), then for the next 6 months was used progestogen in the second phase of the menstrual cycle from 16 to 25 day. Evaluation of indicators of health status were performed after 3, 6 and 12 months of therapy. Assessment of volume of menstrual blood loss was performed using maps of menstrual blood loss and were assessed on a special scale. The total rating for the month, which exceeded 100 points, consistent with menstrual blood loss greater than 80 ml. Results. The influence of hormonal monotherapy progestogen and а-GnRH on menstrual function of women with adenomyosis in combination with endometrial hyperplasia during the follow-up throughout the year. The assessment of indicators of volume of blood loss with the help of monitoring charts. Developed a comprehensive hormone therapy for women of reproductive age with combined benign uterus pathology and the evaluation of its impact on indicators of volume of blood loss and menstrual function of women. Conclusions. Monoterapia by the progestogen and а-GnRH for 6 months of treatment normalizes the indicators of volume of blood loss and menstrual function of women, and the 12-month follow-up in women of these groups also increased the volume of blood loss and each 3 women is marked polimenorea. Developed a comprehensive phased hormone therapy for women with adenomyosis in combination with endometrial hyperplasia normalizes on the 3rd month of treatment indicators of blood loss and has a tendency to decrease during the 12 months of observation (the volume of menstrual blood loss has decreased in 4 times from initial). Key words: complex therapy, adenomyosis, endometrial hyperplasia, gestagene, а-GnRH, menstrual function, volume of blood loss.


Author(s):  
Fadia J Alizzi ◽  
Hind Abdul Khaliq Showman ◽  
Hayder A Fawzi

Objectives: The aim is to detect clinical and ultrasonographic characters that predict the response of adenomyosis to levonorgestrel-releasing intrauterine system (LNG-IUS) and to evaluate the clinical efficacy and the time needed to show a response.Methods: A prospective single-arm study conducted in the Obstetrics and Gynaecology Department Al-Yarmouk Teaching Hospital in Baghdad/Iraq from August 2015 to March 2018. Women with symptomatic adenomyosis with age 39 years and above and who completed their families had been enrolled in this study. LNG-IUS was used as a treatment; the outcome measure was to evaluate its effect in improving the symptoms and the time needed to show a clinical response. Multivariate analysis was used to assess the contribution of the clinical and ultrasonographic parameters to the prediction of the response to LNG-IUS.Results: Over the mean duration of follow-up period of the study (22.7±9.9 months), there was a significant improvement in menstrual blood loss, dysmenorrhea, and hemoglobin (Hb) with significant decrease in uterine volume (p˂0.001). The time to show response was as early as 3 months and the first 6 months is the best time to predict failure. Initial menstrual blood loss and Hb were good predictors to show response while uterine volume an excellent one (positive predictive value 80% and negative predictive value 97.2%).Conclusion: Levonorgestrel-releasing intrauterine device is an effective treatment of symptomatic adenomyosis in term of time to response and duration of response. The presenting Hb, menstrual blood loss, and uterine volume are useful predictors of response.


2021 ◽  
Author(s):  
J J Reavey ◽  
C Walker ◽  
M Nicol ◽  
A A Murray ◽  
H O D Critchley ◽  
...  

Abstract STUDY QUESTION Can markers of human endometrial hypoxia be detected at menstruation in vivo? SUMMARY ANSWER Our in vivo data support the presence of hypoxia in menstrual endometrium of women during physiological menstruation. WHAT IS KNOWN ALREADY Current evidence from animal models and human in vitro studies suggests endometrial hypoxia is present at menstruation and drives endometrial repair post menses. However, detection of human endometrial hypoxia in vivo remains elusive. STUDY DESIGN, SIZE, DURATION We performed a prospective case study of 16 women with normal menstrual bleeding. PARTICIPANTS/MATERIALS, SETTING, METHODS Reproductively aged female participants with a regular menstrual cycle underwent objective measurement of their menstrual blood loss using the alkaline haematin method to confirm a loss of &lt;80 ml per cycle. Exclusion criteria were exogenous hormone use, an intrauterine device, endometriosis or fibroids &gt;3 cm. Participants attended for two MRI scans; during days 1–3 of menstruation and the early/mid-secretory phase of their cycle. The MRI protocol included dynamic contrast-enhanced MRI and T2* quantification. At each visit, an endometrial sample was also collected and hypoxia-regulated repair factor mRNA levels (ADM, VEGFA, CXCR4) were quantified by RT-qPCR. MAIN RESULTS AND THE ROLE OF CHANCE Women had reduced T2* during menstrual scans versus non-menstrual scans (P = 0.005), consistent with menstrual hypoxia. Plasma flow (Fp) was increased at menstruation compared to the non-menstrual phase (P = 0.0005). Laboratory findings revealed increased ADM, VEGF-A and CXCR4 at menstruation on examination of paired endometrial biopsies from the menstrual and non-menstrual phase (P = 0.008; P = 0.03; P = 0.009). There was a significant correlation between T2* and these ex vivo hypoxic markers (P &lt; 0.05). LIMITATIONS, REASONS FOR CAUTION This study examined the in vivo detection of endometrial hypoxic markers at specific timepoints in the menstrual cycle in women with a menstrual blood loss &lt;80 ml/cycle and without significant uterine structural abnormalities. Further research is required to determine the presence of endometrial hypoxia in those experiencing abnormal uterine bleeding with and without fibroids/adenomyosis. WIDER IMPLICATIONS OF THE FINDINGS Heavy menstrual bleeding (HMB) is a common, debilitating condition. Understanding menstrual physiology may improve therapeutics. To our knowledge, this is the first in vivo data supporting the presence of menstrual hypoxia in the endometrium of women with normal menstrual bleeding. If aberrant in those with HMB, these non-invasive tests may aid diagnosis and facilitate personalized treatments for HMB. STUDY FUNDING/COMPETING INTEREST(S) This work was funded by Wellbeing of Women grant RG1820, Wellcome Trust Fellowship 209589/Z/17/Z and undertaken in the MRC Centre for Reproductive Health, funded by grants G1002033 and MR/N022556/1. H.O.D.C. has clinical research support for laboratory consumables and staff from Bayer AG and provides consultancy advice (but with no personal remuneration) for Bayer AG, PregLem SA, Gedeon Richter, Vifor Pharma UK Ltd, AbbVie Inc; Myovant Sciences GmbH. H.O.D.C. receives royalties from UpToDate for articles on abnormal uterine bleeding. TRIAL REGISTRATION NUMBER N/A.


Author(s):  
Uma Gupta ◽  
Kumkum Shrivastava ◽  
Gunjan Katiyar ◽  
Ayesha Arif ◽  
Narendra Kumar Gupta

ABSTRACT Objective To assess the efficacy and safety of ormeloxifene in the medical management of dysfunctional menorrhagia. Methodology Fifty women with menorrhagia were recruited for the study. Ormeloxifene 60 mg twice a week for 3 months from first day of periods and once a week for next 3 months was given. Mean blood loss (MBL) was assessed using pictorial blood loss assessment chart (PBAC). Ultrasonography (USG) and blood hemoglobin levels were done as baseline and at 2, 4 and 6 months of treatment. Side-effects of the drug were recorded. Changes in PBAC scoring, endometrial thickness (ET) and hemoglobin levels (Hb) were analyzed by student's paired ‘t’ tests using SPSS 17.0 version. p value . 0.05 was taken as significant. Results The pretreatment PBAC score was 360, which reduced to 209.5 at 2 months, 88.7 at 4 months and 68.2 at 6 months of treatment, which was statistically significant (p-value . 0.001). The rise in hemoglobin and decrease in ET, in women on ormeloxifene was also statistically significant (p-value . 0.001). Conclusion Ormeloxifene is an effective and safe therapeutic option for the medical management of menorrhagia. How to cite this article Gupta U, Shrivastava K, Katiyar G, Arif A, Gupta NK. Study of Efficacy and Safety of Ormeloxifene in the Management of Dysfunctional Menorrhagia. J South Asian Feder Menopause Soc 2014;2(1):1-4.


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