scholarly journals Study of Efficacy and Safety of Ormeloxifene in the Management of Dysfunctional Menorrhagia

2014 ◽  
Vol 2 (1) ◽  
pp. 1-4
Author(s):  
Uma Gupta ◽  
Kumkum Shrivastava ◽  
Gunjan Katiyar ◽  
Ayesha Arif ◽  
Narendra Kumar Gupta
Keyword(s):  
Side Effects ◽  
Blood Loss ◽  
South Asian ◽  
Medical Management ◽  
Endometrial Thickness ◽  
Therapeutic Option ◽  
P Value ◽  
Efficacy And Safety ◽  
Loss Assessment ◽  
Treatment Side Effects

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.

scholarly journals Medical Management of Dysfunctional Menorrhagia: Is Ormeloxifene a Safe and Efficacious Therapeutic Choice?

2014 ◽  
Vol 2 (2) ◽  
pp. 65-70
Author(s):  
Nidhi Gupta
Keyword(s):  
Blood Loss ◽  
Medical Management ◽  
Endometrial Thickness ◽  
Therapeutic Option ◽  
Loss Assessment ◽  
Therapeutic Choice ◽  
History Of ◽  
Stopping Treatment ◽  
The Mean ◽  
Mean Cycle

ABSTRACT Objective To assess the efficacy and safety of ormeloxifene (centchroman) in the medical management of menorrhagia. Materials and methods One hundred and twenty women with menorrhagia were recruited for the study. One hundred women were analyzed. Ormeloxifene was given to each patient— 60 mg twice a week for 3 months and then once a week for 1 month. Patients were followed up at 2, 4, 6 months of therapy, then at 6 months after treatment was stopped. Menstrual blood loss (MBL) was measured objectively by a pictorial blood loss assessment chart (PBAC) score and subjectively by a visual analog scale (VAS). Results The mean age of the patients was 38.2 years with a mean parity of 2.4. The mean duration of menorrhagia was 13 months with 8 days as mean duration of bleeding and a mean cycle length of 26 days. 58.7% of the patients had bulky uterus on per vaginum examination done by the same observer. The mean endometrial thickness on transvaginal scan was 8.7 mm. The different study parameters were evaluated in patients treated with ormeloxifene and it showed a significant reduction in median PBAC score from 252 to 102.8, presence of clots from 64 to 12%, incidence of dysmenorrhea from 22 to 8% and mean endometrial thickness from 9.7 to 6.7 mm. There was also a significant elevation in the mean hemoglobin levels from 8.85 gm/dl to 10.6 gm/dl. The menstrual pattern of patients treated with ormeloxifene were encouraging. Eight percent of the women became ammenorhoeic after 6 months of therapy, 22% had scanty period, 56% had average flow, 12% had heavy from and only 2% had very heavy flow. It was further seen, that even though the PBAC score increased to 112.7 after stopping treatment for 6 months, but still it was lower than the pretreatment level (252). The percentage of patients who had an initial history of passage of clots during periods decreased from 64 to 12% and also 22% of patients who complained of mild to severe dysmenorrhea improved and only 8% of the patients complained of mild dysmenorrhea. Adverse effects Included ovarian cyst (14%), cervical erosion and discharge (11%), gastric upset (9%), headache (5%) and weight gain (3%). Conclusion Ormeloxifene is an effective and safe therapeutic option for the medical management of menorrhagia. How to cite this article Gupta N. Medical Management of Dysfunctional Menorrhagia: Is Ormeloxifene a Safe and Efficacious Therapeutic Choice? J South Asian Feder Menopause Soc 2014;2(2):65-70.

scholarly journals Evaluation of the Role of Ormeloxifene in Abnormal Uterine Bleeding

2017 ◽  
Vol 5 (2) ◽  
pp. 107-110
Author(s):  
Ritu Sharma ◽  
Savita R Singhal
Keyword(s):  
Side Effects ◽  
Blood Loss ◽  
Endometrial Thickness ◽  
Hormonal Treatment ◽  
Abnormal Uterine Bleeding ◽  
Uterine Bleeding ◽  
Hemoglobin Level ◽  
P Value ◽  
Loss Assessment

ABSTRACT Aim This is a prospective study to find the effect of ormeloxifene on menstrual blood loss and its side effects in patients with abnormal uterine bleeding (AUB). Materials and methods Fifty women in the age group of 30 to 52 years with AUB were enrolled in the study. After baseline assessment, each patient was given 60 mg of ormeloxifene orally twice a week for first 3 months, then once a week for the next 3 months. The patients were followed up after 1, 3, and 6 months. The effect of ormeloxifene was evaluated by a change in the pictorial blood loss assessment chart (PBAC) score, passage of clots during menstruation, hemoglobin level, endometrial thickness (ET), and dysmenorrhea. Side effects of the drug were also noted at each visit; p-value < 0.05 was taken as significant. Results There was statistically significant reduction in median PBAC score from baseline 360 to 113, 73, and 41.5 after 1, 3, and 6 months. There was significant reduction in ET, passage of clots, and dysmenorrhea at each visit. Mean hemoglobin level increased significantly by 1.56 gm% after 6 months treatment. Adverse effects included amenorrhea (28%), ovarian cyst (11.3%), nausea (4.5%), headache (2%), and weight gain (4.5%). There was no major side effect requiring termination of treatment. Conclusion Ormeloxifene is a safe and efficacious alternative for medical therapy in the management of AUB. Clinical significance Ormeloxifene can be used in women with AUB to avoid the side effects of hormonal treatment and unnecessary hysterectomies. How to cite this article Sharma R, Singhal SR. Evaluation of the Role of Ormeloxifene in Abnormal Uterine Bleeding. J South Asian Feder Menopause Soc 2017;5(2):107-110.

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

2020 ◽  
Vol 9 (3) ◽  
pp. 1245
Author(s):  
Sunil Kumar Juneja ◽  
Pooja Tandon ◽  
Gagandeep Kaur
Keyword(s):  
Side Effects ◽  
Blood Loss ◽  
Medical Management ◽  
Endometrial Thickness ◽  
Heavy Menstrual Bleeding ◽  
Menstrual Bleeding ◽  
Menstrual Blood ◽  
Menstrual Blood Loss ◽  
Norethisterone Acetate

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.

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.

scholarly journals Efek Samping Terapi Antiretroviral dan Kepatuhan Berobat Penderita HIV/AIDS

2021 ◽  
Vol 12 (3) ◽  
pp. 389
Author(s):  
Rico Januar Sitorus ◽  
Novrikasari Novrikasari ◽  
Rizma Adliah Syakurah ◽  
Merry Natalia
Keyword(s):  
Medication Adherence ◽  
Side Effects ◽  
Opportunistic Infection ◽  
Multivariate Regression Analysis ◽  
Adherence Rate ◽  
P Value ◽  
Cross Sectional ◽  
Treatment Side Effects ◽  
The City ◽  
Hiv Aids

<p>Antiretroviral treatment side-effects and patient compliance with medical instructions continue to be a growing challenge for HIV/AIDS patients. Arv therapy has resulted in a substantial intervention that has been successful in preventing transmission and opportunistic infection. The main objective of this study was to analyze the association between side-effects of ARV therapy and medication adherence as well as another potential confounding such as opportunistic infection, family support, stress level, knowledge of ARV, marital status, and occupation. This study is a quantitative approach by using cross-sectional methods. A total of 244 respondents from 1.180 patients with confirmed HIV registered in the Care Support and Treatment (CST) service and Sriwijaya Community in the City of Palembang to respond to the survey. Non-random sampling was used to collect the samples. As the result, the majority of the respondents were male (84,43 %), ≥30 years old (57,4%), and secondary school graduates (52%). After adjusting with stress and opportunistic infection variable, a Multivariate regression analysis revealed a positive relationship between side effects and medication adherence (p-value of 0,041; 0,05), OR Adj 2,131 (1,190-4,988). PLHV who had adverse effects had a 2.131 times worse adherence rate than those who did not. In conclusion, medication adherence must be greatly improved in light of therapeutic side effects, stress levels, and opportunistic infection.</p>

scholarly journals Comparison between use of combination of mifepristone and misoprostol versus misoprostol alone in the management of intrauterine fetal death

2018 ◽  
Vol 7 (7) ◽  
pp. 2778
Author(s):  
Sreeveena Talasani ◽  
Pran Hitha Venkamolla ◽  
Kalpana Betha
Keyword(s):  
Side Effects ◽  
Fetal Death ◽  
Intrauterine Fetal Death ◽  
P Value ◽  
Ultrasound Scan ◽  
Efficacy And Safety ◽  
Medical Sciences ◽  
The Mean ◽  
Group 2 ◽  
Group 1

Background: Intrauterine fetal death (IUFD) is estimated to occur in 1% of all pregnancies. The advent of prostaglandins has revolutionized the management of IUFD. There are limited studies using a combined regimen of mifepristone and misoprost for induction of labor in IUFD. Hence this study was undertaken to assess the efficacy and safety of combined regimen with misoprostol alone, in the management of IUFD.Methods: This hospital based prospective study included 60 pregnant women with IUFD admitted at Mediciti Institute of Medical Sciences, during the period January 2015 to July 2016. An ultrasound scan was performed to confirm IUFD and localize the placenta. Women were divided alternatively into 2 groups with 30 in each group (group 1- women received 200 mg mifepristone orally followed by misoprostol after 24 hours & in group 2, 100 µg misoprostol  every 6 hourly for a maximum of 4 doses between gestational age  24-26 weeks, 25-50 µg 4 hourly for a maximum of 6 doses beyond 26 weeks).Results: The mean induction to delivery interval was 10 hours in group 1 and 16.3 hours in group 2 (p value 0.007). Mean dose of misoprostol required in group 1 was 1.87 and 2.67 in group 2 (p value 0.008). With respect to side effects, the two groups did not differ significantly.Conclusions: The combined regimen was more effective than misoprostol for the induction of labour in IUFD, in terms of higher rate of successful delivery and shorter induction to delivery interval. 

scholarly journals Comparison between Ormeloxifene and Norethisterone in reducing menorrhagia in dysfunctional uterine bleeding

2018 ◽  
Vol 7 (12) ◽  
pp. 4966
Author(s):  
Swati Gett ◽  
Shruti Singh
Keyword(s):  
Endometrial Thickness ◽  
Mean Value ◽  
Uterine Bleeding ◽  
The Other ◽  
P Value ◽  
Loss Assessment ◽  
Dysfunctional Uterine Bleeding ◽  
Significant Difference ◽  
Before And After

Background: Dysfunctional Uterine Bleeding (DUB) is a condition that affects nearly every woman at some point in her life. This study aims to compare the efficacy of Ormeloxifene and Norethisterone in reducing menorrhagia in such patients.Methods: This prospective study was done on 100 women presenting with dysfunctional uterine bleeding, of 20-50 years of age, who were ready for follow-up and were allocated into two equal groups, one was given Ormeloxifene and the other was given Norethisterone for a period of 3 months. Haemoglobin levels, endometrial thickness on ultrasound and Pictorial Blood loss Assessment Chart (PBAC) scores were assessed before and after the treatment.Results: It was found that both Ormeloxifene and Norethisterone reduced menorrhagia, with a significant difference in PBAC scores (p value <0.05). There was a notable reduction in PBAC scores in Ormeloxifene group (66.53% change from pretreatment mean value) as compared to Norethisterone group (31.38% change from pretreatment mean value); and same holds true for the change in haemoglobin levels as well as endometrial thickness. Ormeloxifene was found to have a greater effect on heavy menstrual bleeding in comparison to Norethisterone.Conclusions: Ormeloxifene is a new modality and is found to be a better option in reducing menorrhagia in DUB in respect to a greater success rate, better compliance and cost effectiveness.

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 PROPHYLACTIC USE OF MISOPROSTOL FOR THE PREVENTION OF POSTPARTUM HAEMORRHAGE AND ATONIC UTERUS IN CESARION SECTION DELIVERIES.

2011 ◽  
Vol 6 (2) ◽  
pp. 785-789
Author(s):  
NUZHAT AMIN
Keyword(s):  
Side Effects ◽  
Blood Loss ◽  
Post Partum ◽  
Protective Measure ◽  
Control Group ◽  
P Value ◽  
Study Group ◽  
Poor Countries ◽  
Significant Difference ◽  
Prophylactic Use

BACK GROUND: Post partum hemorrhage still remains a major cause of maternal death. Syntocinonis the first line protective measure in this regard. However this is heat sensitive and losses its efficacyafter storage for some time. On the other hand misoprostol do not losses its efficacy for long time afterstorage, is cheap, can be stored at room temperature and give the same result as syntocinon in preventingpostpartum hemorrhage and atonic uterus.OBJECTIVE: To assess the prophylactic use of misoprostol in preventing PPH and management ofatonic uterus, and compare it with conventional i/v syntocinon routinely used in hospitals for cesariondeliveries.MATERIAL AND METHODS: This is a semi experimental study, which was conducted in Mardanmedical complex Hospital Mardan, department of obstetrics and gynecology unit A, between May 2014to May 2015. 200 women have give birth to their babies by C-section were included in the study anddivided into 2 groups, a control group (100 women who received syntocinon) and a study group (100women who received rectal misoprostol). Syntocinon lOu i/v injection and misoprostol 800ug (4tablets)per rectum were given to women in control and study group respectively, immediately after delivery ofthe baby. Blood loss after delivery and frequency of atonic PPH were recorded and compared betweenthe two groups. Side effects of both drugs were also noted.RESULTS: There was no significant difference in blood loss after delivery. Control group 250ml, studygroup 300ml, P value -0.18). The frequency of atonic PPH in study and control groups was similarranging between 3% and 4%.Side effects of misoprostol ( shivering 25% , fever 15% , vomiting 12%and diarrhea 5%) were significant ( P value <0.05 ) but all were temporary and not life threatening.CONCLUSION: Misoprostol can be used for the prevention of PPH and to reduce atonic uterus afterC-section deliveries, especially in poor countries where facilities for storage of oxytocin are notavailable. Benefits of misoprostol outweigh its side effects.Key Words: prophylaxis, atonic postpartum hemorrhage, rectal, misoprostol, syntocinon,underdeveloped countries.

scholarly journals Approaches to the rational choice of type 5 phosphodiesterase inhibitors in patients presenting with cardiovascular and endocrine diseases

2010 ◽  
Vol 56 (6) ◽  
pp. 63-72
Author(s):  
V V Rafal'skiĭ ◽  
A N Baglikov
Keyword(s):  
Erectile Dysfunction ◽  
Side Effects ◽  
Rational Choice ◽  
Therapeutic Option ◽  
Phosphodiesterase Inhibitors ◽  
Pharmaceutical Products ◽  
Efficacy And Safety ◽  
Adverse Side Effects ◽  
Endocrine Diseases ◽  
Type 5 Phosphodiesterase Inhibitors

After the advent of four type 5 phosphodiesterase inhibitors (PDEI 5), viz. sildenafil, tadalafil, vardenafil, and udenafil, designed for the treatment of erectile dysfunction both physicians and patients found themselves faced with the problem of choosing an optimal therapeutic option. This paper contains comparative data on the efficacy and safety of different PDEI 5. The approaches to the rational choice of these preparations for the treatment of patients presenting with cardiovascular and endocrine diseases are discussed. Comparative controlled clinical studies failed to yield definitive information about advantages of one or another agent representing this group of pharmaceutical products. Nevertheless, the currently available data permit to draw the conclusion that the use of vardenafil and tadalafil ensures better compliance of patients with the prescribed therapy. Certain authors advocate the desirability of vardenafil application to the treatment of patients presenting with a background pathology. It is emphasized that all available PDEI 5 have a beneficial safety profile, with wardenafil being virtually free from adverse side effects.

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