scholarly journals Efficacy and safety of ormeloxifene in the management of dysfunctional uterine bleeding

2019 ◽  
Vol 8 (5) ◽  
pp. 1864
Author(s):  
Sabah Malik ◽  
Saba Musharaf ◽  
Fidah Malik ◽  
Mohd Abass
Keyword(s):  
Blood Loss ◽  
Endometrial Thickness ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Menstrual Blood ◽  
Prospective Clinical Study ◽  
Efficacy And Safety ◽  
Menstrual Blood Loss ◽  
Dysfunctional Uterine Bleeding ◽  
The Mean

Background: The term dysfunctional uterine bleeding (DUB) is used for abnormal uterine bleeding occurring in the absence of identifiable pathology. A number of drugs are available for management of DUB- nonsteroidal anti-inflammatory drugs, tranexamic acid, ethamsylate, hormones like Oral contraceptives progestins etc. The present study was done to determine the efficacy and safety of ormeloxifene in the management of DUB.Methods: This prospective clinical study involved 50 cases with DUB who were treated with ormeloxifene 60 mg tablet twice a week for first 12 weeks and the once a week for next 12 weeks. They were followed after 6 months of therapy. The outcome was studied by assessment of menstrual blood loss by PBAC score, Hb level in g/dl, endometrial thickness in mm, relief of dysmenorrheal and any side effects of drugs.Results: The median PBAC score was significantly reduced from 316 to 52 after 6 months of therapy. The mean Hb concentration was significantly increased from 7.8 g/dl to 9.1 g/dl at 6 months of therapy. The mean endometrial thickness was reduced from 10 mm to 7.9 mm after 6 months of therapy. 66% of women showed marked subjective improvement in symptoms. Amenorrhea was the main side effect (12%).Conclusions: Ormeloxifene has significant effect in reducing endometrial thickness, decreasing the amount of menstrual blood loss, reducing dysmenorrhea and thereby improving the general condition of the patient. It is definitely a better alternative to hysterectomy in women who wish to avoid surgeries and maintain their reproductive functions.

scholarly journals Ormeloxifene versus combined oral contraceptive pills to control blood loss in cases of dysfunctional uterine bleeding

2019 ◽  
Vol 8 (12) ◽  
pp. 4909
Author(s):  
Ankita Gupta ◽  
Rishika Raj
Keyword(s):  
Oral Contraceptive ◽  
Blood Loss ◽  
Endometrial Thickness ◽  
Uterine Bleeding ◽  
Menstrual Blood ◽  
Control Group ◽  
Dysfunctional Uterine Bleeding ◽  
Oral Contraceptive Pills ◽  
Combined Oral Contraceptive ◽  
Contraceptive Pills

Background: Dysfunctional uterine bleeding is one of the most often encountered gynecologic problems causing anemia, reduced quality of life and unnecessary hysterectomies. A prospective study was conducted on women with DUB to study the effect of ormeloxifene versus combined oral contraceptive pills in controlling blood loss in them.Methods: 100 Women with DUB were enrolled randomly in three groups. After baseline assessment each patient in group A was treated with iron tablets, containing 100 mg elemental iron and folic acid 1.5 mg, for three months and were termed as control group. Group B patients were treated with ormeloxifene in dose of 60 mg twice a week for twelve weeks. Group C patients were treated with combined oral contraceptive pills for twenty- one days starting from third day of their LMP. The treatment was continued for three consecutive cycles. The efficacy of the studied drugs was analyzed by comparing the baseline and post treatment PBAC score, haemoglobin level and endometrial thickness, using appropriate statistical tests.Results: Ormeloxifene was more effective than only iron or combined oral contraceptive therapy in controlling menstrual blood loss (79.11% versus 58.57%). There was a reduction in endometrial thickness in group receiving ormeloxifene as well as in the group receiving combined oral contraceptive pills (p=0.486), however this was statistically not significant.Conclusions: Ormeloxifene was significantly better than combined OCP in reduction of menstrual blood flow in cases of DUB. It has better compliance and marked improvement in subjective symptoms as compared to OCP.

scholarly journals Markers of human endometrial hypoxia can be detected in vivo and ex vivo during physiological menstruation

2021 ◽  
Author(s):  
J J Reavey ◽  
C Walker ◽  
M Nicol ◽  
A A Murray ◽  
H O D Critchley ◽  
...  
Keyword(s):  
Menstrual Cycle ◽  
Blood Loss ◽  
Ex Vivo ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Menstrual Bleeding ◽  
Menstrual Blood ◽  
Menstrual Phase ◽  
Menstrual Blood Loss

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 <80 ml per cycle. Exclusion criteria were exogenous hormone use, an intrauterine device, endometriosis or fibroids >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 < 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 <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.

scholarly journals COMPARISON OF EFFICACY AND SAFETY OF ORMELOXIFENE AND CYCLICAL PROGESTERONE (NORETHISTERONE) IN OVULATORY ABNORMAL UTERINE BLEEDING

2020 ◽  
pp. 178-180
Author(s):  
DIVYA VARDAINI ◽  
RAKESH MISHRA ◽  
RASHMI RANJAN ◽  
SWAPNALI R BORADE
Keyword(s):  
Blood Loss ◽  
Medical Management ◽  
Endometrial Thickness ◽  
Abnormal Uterine Bleeding ◽  
Cost Effective ◽  
Uterine Bleeding ◽  
Reproductive Age ◽  
Age Group ◽  
Efficacy And Safety ◽  
Reproductive Age Group

Objective-To determine the efficacy and safety  of ormeloxifene versus progesterone in controlling Ovulatory Abnormal Uterine Bleeding(AUB-O) Methods-A Prospective Randomized comparative study of total 100 females of reproductive age group 25 to 45 years with AUB-O.Patients were randomly divided in two groups of 50 each. Results-The study showed ormeloxifene was found to be more effective and safe than Norethisterone in AUB-O. Ormeloxifine as compared to norethisterone is more effective in improving Hb and reducing endometrial thickness. Hence, ORM is more superior than Norethisterone Conclusion-In this study ormeloxifene was found to be more effective in reducing blood loss,that leads to improvement in mean haemoglobin and also it had more ability to reduce endometrial thickness.As both ormeloxifene and norethisterone are very effectivebut ormeloxifene is safe , cost effective ,nonsteroidal, non hormonal drug with convenient dosage and better compliance for medical management of AUB-O.Hence, ormeloxifene canbe considered as first drugs in the management of AUB-O.

Establishment Of a Reference Range For The Pbac-Score

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4772-4772 ◽  
Author(s):  
Susan Halimeh ◽  
Hannelore Rott ◽  
Guenther Kappert ◽  
Manuela Siebert
Keyword(s):  
Blood Loss ◽  
Blood Count ◽  
Reference Range ◽  
Bleeding Disorder ◽  
Von Willebrand Disease ◽  
Menstrual Blood ◽  
Control Group ◽  
Menstrual Blood Loss ◽  
The Mean ◽  
Von Willebrand

Introduction Heavy menstrual bleeding (HMB) is defined as bleeding that lasts for more than seven days or as the loss of more than 80mL of blood per mentrual cycle (1)The menstrual blood loss can be quantified by the use of a pictorial bleeding assessment chart (PBAC). The PBAC-Score was initially validated by Higham et al. (2) With the PBAC-Score the women can capture the number of pads or tampons and also state the intensity through the assessment of the drenching. The aim of this study was to establish a reference range for the PBAC-Score. Samples and Methods We analysed samples of 310 women with menorrhagia and 108 controls by conducting the following tests: Blood count, VWF:RCo, VWF:Ag, VWF:CB, VWF:multimers, Fibrinogen (Clauss), activities of FII, FV, FVII, FVIII (clotting and chromogenic), FIX, FX, FXI, FXII, FXIII. In all women the menstrual blood loss was quantified usind the PBAC-Score and the results were compared. Results In 202 of 310 women (65.1%) a bleeding disorder could be detected. In those with a bleeding disorder, the distribution was as followed: 64% of these women had a von Willebrand disease, 7.2% FVII-deficiency, 7.7% FXIII-deficiency and the remaining 21.1% other mild factor dificiencies. The mean PBAC-Score in women with menorrhagia was 262 (range 31 – 4212) in our control group the mean PBAC-Score was 60 (range 8 – 97). Discussion/Conclusion Attemps to measure the quantity of menstrual blood loss can be useful in clinical practice. In our opinion the best cut of for the PBAC-Score is 100 with a sensitifity of 90% and a specifity of 100%. We found a high correlation of a PBAC >100 and an inherited bleeding disorder, especially von Willebrand diesease. In 65.1% of our patients an abnormal coagulation was found. In 4 (3.7%) women of the control group slightly abnormal von Willebrand parameters could been dectected. We validated the reference range for the PBAC-Score as 0 - 100. Disclosures: Halimeh: Octapharma AG: Investigator Other, Research Funding.

scholarly journals Comparative Study of Desogestrel- Containing Oral Contraceptive and Levonorgestrel- Containing Oral Contraceptive in Dysfunctional Uterine Bleeding

2020 ◽  
Vol 11 (4) ◽  
pp. 5678-5684
Author(s):  
Swathi Suresh ◽  
Mariya Els Johny ◽  
Kiruba Shankari ◽  
Ahamed Irshath U ◽  
Yokesh M ◽  
...  
Keyword(s):  
Weight Gain ◽  
Oral Contraceptive ◽  
Side Effects ◽  
Menstrual Cycle ◽  
Blood Loss ◽  
Ethinyl Estradiol ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Dysfunctional Uterine Bleeding ◽  
Group D

Dysfunctional uterine bleeding is a type of abnormal uterine bleeding where vaginal bleeding occurs outside of the menstrual cycle in the absence of any known pelvic pathology. Dysfunctional uterine bleeding can be treated safely with hormone therapy. Combined oral contraceptives help in increased menstrual cycle regularity and decreased blood loss. In this study, a reliable drug for the dysfunctional uterine bleeding with maximum effectiveness and minimal side effects were assessed. This study was conducted on 120 cases of dysfunctional uterine bleeding. Patients who were diagnosed with dysfunctional uterine bleeding were randomly assigned into two groups. Group D and group L included patients who were given Ethinyl estradiol 0.02mg + desogestrel 0.15mg and Ethinyl estradiol 0.03mg + levonorgestrel 0.15mg respectively for the four consecutive 28- day cycles. Menstrual blood loss was assessed using the pictorial blood assessment chart (PBAC) score on 2nd and 4th months of recruitment. Side effects such as weight gain, acne and headache were assessed in both groups. This study shows 56.68% reduction in mean PBAC score in 2 months in desogestrel group whereas only 44.96% reduction in levonorgestrel group and 79.87% reduction in mean PBAC score in desogestrel group in 4 months whereas only 74.46% reduction in levonorgestrel group. Side effects like weight gain, acne and headache were more prominent in the levonorgestrel group than desogestrel group. Desogestrel containing combined oral contraceptive can be a useful and safe treatment for dysfunctional uterine bleeding.

scholarly journals The role of Sevista (ormeloxifene) in the management of dysfunctional uterine bleeding

2016 ◽  
Vol 6 (1) ◽  
pp. 219 ◽  
Author(s):  
Nikita Gandotra ◽  
Preeti Sharma ◽  
Abhinav Sharma ◽  
Syed Masuma Rizvi
Keyword(s):  
Side Effects ◽  
Outcome Measures ◽  
Medical Management ◽  
Endometrial Thickness ◽  
Hemoglobin Concentration ◽  
Uterine Bleeding ◽  
Secondary Outcome ◽  
Dysfunctional Uterine Bleeding ◽  
The Mean

Background: Dysfunctional uterine bleeding (DUB) is a common gynaecological disorder that usually ends up in hysterectomy and causes psychological and physiological stress. Medical management with hormones and NSAIDS has inherited side effects. Ormeloxifene, a selective estrogen receptor modulator, is emerging as a safe and effective agent for dysfunctional uterine bleeding. The objective of the study was to evaluate the role of ormeloxifene in medical management of dysfunctional uterine bleeding.Methods: 30 patients, on whom diagnosis of dysfunctional uterine bleeding was made, were included in the study. Patients were given ormeloxifene 60mg twice a week for 12 weeks and then once a week for 12 weeks. The primary outcome measures were menstrual blood loss (assessed by pictorial blood assessment chart score), hemoglobin concentration and endometrial thickness. The secondary outcome measures were acceptability and side effects of ormeloxifene.Results: There was a significant reduction in mean PBAC score from 316 to 52 after six months of treatment. The mean hemoglobin concentration increased significantly from 8.4 to 9.8 gms/dl with a rise of 1.4gm/dl (p <0.05). The mean pretreatment endometrial thickness was 10.8mm and it decreased significantly to 8.1mm after 6 months of treatment with ormeloxifene (p < 0.05). 76.7% of the women showed marked subjective improvement in symptoms. The most common side effect reported was amenorrhea (13.3%).Conclusions: Ormeloxifene can be considered as an effective and safe therapeutic option for the medical management of dysfunctional uterine bleeding.

scholarly journals LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM IN ADENOMYOSIS; PREDICTORS FOR RESPONSE AND CLINICAL OUTCOME

2018 ◽  
Vol 11 (12) ◽  
pp. 214
Author(s):  
Fadia J Alizzi ◽  
Hind Abdul Khaliq Showman ◽  
Hayder A Fawzi
Keyword(s):  
Blood Loss ◽  
Predictive Value ◽  
Intrauterine Device ◽  
Menstrual Blood ◽  
Menstrual Blood Loss ◽  
Predictors Of Response ◽  
Duration Of Response ◽  
The Mean ◽  
Uterine Volume

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.

scholarly journals Therapeutic tactics in abnormal uterine bleeding without anatomical substrate

2019 ◽  
pp. 168-172
Author(s):  
G. В. Dikke
Keyword(s):  
Blood Loss ◽  
Abnormal Uterine Bleeding ◽  
Similar Efficacy ◽  
Uterine Bleeding ◽  
Reduce Blood Loss ◽  
Intrauterine Devices ◽  
Menstrual Blood Loss ◽  
First Line ◽  
Structural Abnormalities ◽  
Proven Efficacy

The purpose of the review:presentation of modern data on the pathogenesis of abnormal uterine bleeding (AMC) without anatomical substrate (ovulatory, endometrial, coagulopathic) and the effectiveness of their treatment with medication.Basic provisions.Information on the pathogenesis of AMC not associated with structural abnormalities of the uterus is presented. It was shown that non-hormonal drugs have similar efficacy. Among the hormonal agents, levonorgestrel-containing intrauterine system (IUD-LNG) and estrogen-progestogen preparations (combined oral contraceptives, COCs) favorably differ. COCs recover an acute episode of AMC in 66.8% of cases (according to some data – in 88%), which is higher in comparison with non-hormonal drugs; in chronic cases – reduce blood loss by 88% (after 6 months of therapy), and are not inferior in effectiveness to intrauterine devices with levonorgestrel (83% after 3 months of therapy).The conclusion.Thus, non-hormonal drugs have similar efficacy in arresting AMC without an anatomical substrate, but are inferior to COCs. In case of chronic AMC, the first-line drugs are IUD-LNG and COC containing E2B / NNG, which contribute to the normalization of the menstrual cycle and the volume of menstrual blood loss with proven efficacy.

scholarly journals A CASE REPORT ON EFFECTIVE MANAGEMENT OF ASRIGDARA

2020 ◽  
pp. 106-111
Author(s):  
Khushboo Jha ◽  
K. Bharathi ◽  
Sonu
Keyword(s):  
Blood Loss ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Menstrual Bleeding ◽  
Menstrual Blood Loss ◽  
Loss Assessment ◽  
Sf 36 ◽  
Before And After ◽  
Normal Menstrual Cycle

Any uterine bleeding outside the normal volume, duration, regularity or frequency is considered as abnormal uterine bleeding (AUB). Nearly thirty percent of all gynaecological outpatient attendants are for AUB. Abnormal menstrual bleeding pattern have been traditionally expressed by terms like menorrhagia, metrorrhagia, polymenorrhagia & oligomenorrhoea. Normal menstrual cycle interval is 28 days (21-35 days), menstrual flow duration 4-5 days and normal menstrual blood loss should be 35ml (20-80 ml). Any deviation in the above criteria comes under abnormal uterine bleeding, means excessive amount of bleeding or increased duration of bleeding during menstruation or both termed as AUB. In Ayurveda same is described as Pradara. A female patient aged 22 years visited OPD of Prasuti Tantra and Stri Roga department of NIA, with complaints of heavy menstrual bleeding and prolonged menstrual bleeding more than seven days since six months. Pictorial blood loss assessment chart was used to assess the amount of blood loss before and after treatment. SF-36 questionnaire was assessed to know the improvement in quality of life. Patient was given Kutajashtakaleha 10 gm BD with cows milk.

scholarly journals Ormeloxifene versus Medroxyprogesterone Acetate (MPA) in the Treatment of Dysfunctional Uterine Bleeding: A Double-Blind Randomized Controlled Trial

2011 ◽  
Vol 3 (1) ◽  
pp. 21-24 ◽  
Author(s):  
MB Bellad ◽  
D Mekhala ◽  
Jyotsna Shravage ◽  
MS Ganachari ◽  
HA Dhumale
Keyword(s):  
Blood Loss ◽  
Medroxyprogesterone Acetate ◽  
Endometrial Thickness ◽  
Controlled Trial ◽  
Dysfunctional Uterine Bleeding ◽  
Double Blind ◽  
Randomized Controlled ◽  
Group A ◽  
The Mean ◽  
Group B

ABSTRACT Objective To find the effectiveness of ormeloxifene vs medroxyprogesterone acetate (MPA) to reduce blood loss in dysfunctional uterine bleeding (DUB). Materials and methods: Design—A double blind randomized controlled trial. Data source—The women attending gynecology OPD in teaching hospital attached to Jawaharlal Nehru Medical College, Belgaum, India for menorrhagia, meeting the selection criteria were enrolled into the study. Randomization—Computer-generated randomization, with block size of two, was done into two groups. Intervention—One group (group A) received capsule ormeloxifene 60 mg to be taken two days a week at an interval of 3 days, and a placebo form of medroxyprogesterone acetate for 21 days starting from day 2 to 5 of the menstrual cycle for three consecutive cycles. Other group (group B) received medroxyprogesterone acetate (MPA) 10 mg for 21 days starting from day 2 to 5 of the menstrual cycle, and a placebo form of ormeloxifene for 2 days a week with an interval of 3 days for three consecutive cycles. The drug and its placebo were in similar capsular form. All the participants were ensured to use the similar type of sanitary napkins, and transvaginal ultrasonography was done to note the endometrial thickness (ET) before and after the drug therapy. Blinding—The department of clinical pharmacy prepared the drug packets and kept the randomization code till the data was analyzed, thus ensuring the double blinding. Outcome Participants were interviewed during subsequent cycle. Pictorial blood assessment chart (PBAC) score was used to calculate blood loss during menses at the first and subsequent three months. Data analysis The mean PBAC scores and endometrial thickness were compared in two groups. Results The mean pretreatment PBAC scores in group A and group B were 262.26 and 238.71 ml respectively. The mean PBAC scores at the end of the study period were 73 and 108 in group A and B respectively, reporting an overall reduction in mean blood loss by 85.7 and 54.76% (p = 0.0205) in group A and B respectively. Thus, there was a significant reduction in blood loss in the group receiving ormeloxifene. The reduction in the mean endometrial thickness was more in ormeloxifene group. However, this was not statistically significant (p = 0.0942). Conclusion Ormeloxifene is more effective as compared to MPA in reducing the blood loss in the treatment of DUB.

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