Delving into the Latest Updates on Ormeloxifene with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ormeloxifene (INN), Centron, Choice 7

+ [1]

Target

ER

Action

modulators

Mechanism

ERs modulators(Estrogen receptors modulators)

Therapeutic Areas

Urogenital DiseasesOther Diseases

Active Indication

ContraceptionUterine Hemorrhage

Inactive Indication-

Originator Organization-

Active Organization-

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1991),

ContraceptionUterine Hemorrhage

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC30H35NO3

InChIKeyXZEUAXYWNKYKPL-ZTMACLEXSA-N

CAS Registry31477-60-8

ABSTRACTIntroduction:India is committed to achieving universal health care for all by 2030. The objective of social marketing is to promote public health and its goal is to improve health for all, but there are some challenges like irregular availability, quality issue, inadequacy of marketing causes under- utilization of the government supplied health consumables.Objectives:Present study aims to find out the usage pattern and assess the perceived satisfaction level of beneficiaries of using various socially marketed health consumables at government settings and explore the perception of healthcare personnel regarding barriers to its usage in a rural area of India.Materials and Methods:A community-based, Mixed-Methods study (Convergent parallel design) was done in the service area of the Rural Health Unit and Training Centre (RHU&TC), Singur of Hooghly district, West Bengal, between January 2023 and December 2023, where the quantitative component was carried out by face-to-face interview among 150 beneficiary household respondents selected by two-stage cluster sampling; and qualitative component was done by 4 Key informant interviews (KII) among healthcare personnel (medical officer, public health nurse, pharmacist). Statistical data were analyzed by descriptive statistics using SPSS 16 version and Microsoft Excel for the quantitative part, and thematic analysis was done for the qualitative part. Institutional Ethics Committee clearance was obtained.Results:Ever use of government-supplied contraceptives like Chhaya (Ormeloxifene), Antara (Injectable contraceptive), emergency contraceptive pills, and intrauterine contraceptive devices (IUCD) was done by only 15.3%, 10.7%, 7.3%, 32% of eligible beneficiary households, respectively. The major reasons cited for irregular use were unawareness of availability of the products (Chhaya = 76.3%, Antara = 64.9%, EC pills = 46.7%), poor faith regarding quality (Male condom = 40%, Generic medicines = 70%), inadequate promotion (IUCD = 53.9%). The majority of users of male condoms (90%), IFA tablets (52.9%), ORS (51.1%), and generic medicines (55.7%) were not satisfied after using those products. Key informant interviews among healthcare personnel revealed avoidance of using modern contraceptive methods and frequent unavailability of some socially marketed health consumables were the predominant causes of reduced uptake of those products by beneficiaries.Conclusions:Proper social marketing strategies, adequate promotion, regular awareness campaigns, and tailored training of field healthcare workers are required to improve the acceptability, availability, and marketing of these health consumables.

01 May 2024·Journal of Clinical and Experimental Hepatology

Clinical Features, Laboratory Characteristics and Outcome from Oral Contraceptives-induced Liver Injury in 43 Consecutive Patients and a Brief Review of Published Reports

Article

Author: Devarbhavi, Harshad ; Chowdhury, Abhijit ; Patil, Mallikarjun ; Dhali, Gopal K ; Pavan Kumar, Y M ; Mishra, Amit

BackgroundHormonal oral contraceptive (OC) agents such as estrogen or progesterone, either as single agents or in combination, and a non-hormonal drug like ormeloxifene are used for various conditions. However, estrogen and progesterone-containing OC as well as ormeloxifene are seldom associated with hepatotoxicity. We prospectively studied the clinical, demographic, liver injury pattern, complications, and outcome of the hepatotoxicity from OC and ormeloxifene.MethodsWe analyzed and compared the aforementioned characteristics among consecutive patients with OC and ormeloxifene-induced drug-induced liver injury (DILI) from two university hospitals in India. Cases fulfilling established DILI criteria and the Roussel Uclaf causality assessment method were identified and followed up until recovery/death.ResultsWe identified 43 (3.5%) amongst 1226 patients with DILI; 19 (44%) from estrogen and progesterone combination, 21 (49%) from progesterone monotherapy, and 3 (7%) due to ormeloxifene. Seven cases were identified from 1998 to 2014 and 36 cases from 2015 to 2023. All were due to oral tablets. The mean age was 36 years (range 21-75). Nineteen patients (44%) developed jaundice and 5 (11.6%) developed itching. The liver injury pattern was hepatocellular in 19 (44%), mixed in 13 (30%), and cholestatic in 11 (26%). Four patients (9%) died, three from acute liver failure and one due to acute on chronic liver failure. Liver biochemical tests normalized after a mean of 66 days after stopping the implicated agents. Contrastingly, literature search yielded 24 cases of progesterone DILI reported between 1962 and 2019 with no mortality.ConclusionIn contrast to published literature on oral contraceptives, a majority of oral contraceptive-induced DILI in our series were from progesterone monotherapy and a smaller number with ormeloxifene, that often resulted in clinically significant jaundice or liver test abnormalities and rarely in fatality.

01 May 2024·World Journal of Surgery

Double blind randomized controlled trial of efficacy of ormeloxifene for the treatment of fibroadenoma (The FIBROCENT study)

Article

Author: Agrawal, Kratika ; Sharma, Deepti Bala ; Yadav, Sanjay Kumar ; Silodia, Ashutosh ; Sharma, Dhananjaya

AbstractBackgroundWe evaluated the effectiveness of Ormeloxifene (Centchroman) on regression of Fibroadenoma in a double‐blind randomized controlled trial.MethodsPatients with biopsy proven Fibroadenoma were enrolled between March 2023 and October 2023 and divided in two arms‐ Ormeloxifene group and Placebo group. Effectiveness of the treatment was evaluated using USG. No residual mass was defined as complete regression and more than 30% decrease in size was considered as partial regression.ResultsA total of 130 consecutive patients with Fibroadenoma were randomized to Ormeloxifene group (n = 65) and Placebo Group (n = 65). Complete regression was observed in 9% (6/65) patients in Ormeloxifene group and 10.8% (7/65) in Placebo Group at the end of 12 weeks (p = 0.49). Twenty one patients taking Ormeloxifene reported adverse events as compared to none in the other group.ConclusionIn our study Ormeloxifene was not found to be effective in treatment of fibroadenoma and had concerning side effects.

100 Deals associated with Ormeloxifene

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D08301	Ormeloxifene	G03XC04	DB13310

R&D Status

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Contraception	-	-	01 Jan 1991
Uterine Hemorrhage	-	-	01 Jan 1991

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2023	Not Applicable	Acute Myeloid Leukemia	-	CPX-351	(ebsaqjtvrd) = nyyleyeeua isnhyjdwlr (imxvqqkysc ) View more	-	08 Jun 2023
				7+3 chemotherapy	(ebsaqjtvrd) = jazkldppui isnhyjdwlr (imxvqqkysc ) View more
EHA2022	Not Applicable	Acute Myeloid Leukemia	189	Standard dose anthracycline	giergxdajk(akffnekync) = naxzujnbpj nnsbpvslsc (ccugqihwlb )	-	12 May 2022
				Higher dose anthracycline	giergxdajk(akffnekync) = qrlxjosbar nnsbpvslsc (ccugqihwlb )
EHA2022	Not Applicable	High Risk Myelodysplastic Syndrome	76	CPX-351	(tbqcmdscpy) = lohxkltrkf fsblqfshfx (ogpdccyial ) View more	-	12 May 2022
				FLAG-IDA	(tbqcmdscpy) = mlfdzlgvua fsblqfshfx (ogpdccyial )
EHA2020	Not Applicable	FLT3 positive Acute Myeloid Leukemia	9	7+3-Ida and midostaurin	nmripwgjwf(xilhktrxij) = Early mortality rate (30-days) was noted to be 22% (n=2). Death was secondary to disease complication of sepsis and respiratory failure ynxyvddyht (gbkqtnmnmx ) View more	-	14 May 2020
EHA2019	Phase 3	Acute Myeloid Leukemia Consolidation	309	CPX-351	(bxblrjqzrg) = ulwloxutbr kpeetyozrf (jrqlmqgfps ) View more	Positive	14 Jun 2019
				7+3	(bxblrjqzrg) = aueqeyiwwa kpeetyozrf (jrqlmqgfps ) View more
EHA2019	Phase 3	Acute Myeloid Leukemia Consolidation	309	CPX-351	(ljwtxaeewq) = iwrinwaueg rdxkjtmmeo (xuwbapmgod )	-	16 May 2019
				7+3	(ljwtxaeewq) = ejmeszweto rdxkjtmmeo (xuwbapmgod )
EHA2017	Phase 3	Acute Myeloid Leukemia Consolidation	-	CPX-351	hykvgtqfqs(ixbeutssht) = no clinically meaningful differences in the rates of grade ≥3 treatment-emergent adverse events, including febrile neutropenia (68% vs 71%, respectively) and infections (55% vs 51%) apstpjzxsj (dwgbmumaue )	Positive	18 May 2017
				7+3 chemotherapy
ASCO2016	Not Applicable	Acute Myeloid Leukemia	100	7+3	(cnimubinsf) = juidraplwg czsxoiclme (fcdeugihsd ) View more	Positive	20 May 2016
				7+3 plus nilotinib	(cnimubinsf) = kyabdvlxcq czsxoiclme (fcdeugihsd ) View more