Effect of medroxyprogesterone versus placebo after hysteroscopic polypectomy on the clinical response and recurrence of endometrial polyp: a single-blind randomized clinical trial

Start Date21 Dec 2024

Sponsor / Collaborator

Hamedan University of Medical Sciences

NCT06665997

/ Not yet recruitingPhase 4IIT

Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females with Sickle Cell Disease

This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease.
Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. They will complete a 3-month "baseline "with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of Depo-Provera. Participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.

Start Date01 Dec 2024

Sponsor / Collaborator

University of Pennsylvania

[+1]

IRCT20181028041484N2

/ RecruitingNot ApplicableIIT

Comparing the Effects of Oral Caffeine and Medroxyprogesterone on Improving Respiratory Function in Traumatic Brain Injury Patients Under Mechanical Ventilation

Start Date21 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Medroxyprogesterone Acetate

100 Translational Medicine associated with Medroxyprogesterone Acetate

100 Patents (Medical) associated with Medroxyprogesterone Acetate

12,774

Literatures (Medical) associated with Medroxyprogesterone Acetate

01 Feb 2025·Public Health

Childhood maltreatment and its dose-response relation with non-suicidal self-injury among adolescents: The mediating role of mobile phone addiction

Article

Author: Peng, Chang ; Wang, Yan ; Zhang, Nan ; Xu, Zixuan ; Hu, Jie ; Rong, Fajuan ; Guan, Meiqi ; Yu, Yizhen ; Cheng, Junhan

OBJECTIVESThe associations between childhood maltreatment (CM) and mobile phone addiction (MPA), as well as non-suicidal self-injury (NSSI) have been extensively explored. However, the dose-response relationship between CM and NSSI remains inconsistent. Furthermore, there is limited understanding of the potential mediation effect of MPA on the relationship between CM and NSSI. This study aimed to explore the dose-response relationship between CM and NSSI and investigate the potential mediating role of MPA in this relationship.STUDY DESIGNCross-sectional study. Cross-sectional study.METHODSIn the cross-sectional study, a total of 21481 adolescents were selected using a multi-stage cluster sampling method in China. CM, MPA, and NSSI were obtained via self-reports. Data were analyzed using logistic regression models, restricted cubic spline (RCS) functions, and mediation models.RESULTSA total of 38.1 % of adolescents reported engaging in NSSI at least once. Compared with participants without CM, participants with more types of CM (cumulative childhood maltreatment, CCM) had a higher risk of NSSI (P-trend in all models <0.001). RCS further confirmed the dose-response relationships between the continuous change in CM (scores) and the risk of NSSI (P for non-linearity <0.001). Mediation analysis indicated that the relationship between CM (scores) and NSSI was mediated by MPA, and the indirect effect (β = 1.07 × 10^-3, 95 % CI: 9.62 × 10^-4, 1.19 × 10^-3) accounted for 22.23 % of the total effect.CONCLUSIONSThere was a dose-response relationship between CM and the NSSI, and the relationship was mediated by MPA. Interventions targeting MPA may reduce the risk of NSSI among adolescents who have experienced CM, particularly those with CCM.

01 Feb 2025·AIDS

Bone density changes in young women in Uganda using tenofovir-based HIV preexposure prophylaxis and depot medroxyprogesterone acetate contraception

Article

Author: Wyatt, Christina ; Mujugira, Andrew ; Zewdie, Kidist ; Thomas, Katherine K. ; Mugwanya, Kenneth ; Yin, Michael T. ; Badaru, Josephine ; Matovu, Flavia ; Muwonge, Timothy R. ; Morrison, Susan ; Stein, Gabrielle ; Nakyanzi, Agnes ; Bambia, Felix ; Ssebuliba, Timothy ; Heffron, Renee

Background:Injectable depot medroxyprogesterone acetate (DMPA) is the most common contraceptive choice among young women in Uganda, where HIV burden is high and HIV preexposure prophylaxis (PrEP) may be offered. For young women who choose to use both agents concurrently, it is unknown whether they will experience declines in bone mineral density (BMD) beyond those elicited by either product singly.Methods:From 2018 to 2022, we conducted a 2-year prospective study with women ages 16–25 years in Kampala, Uganda desiring pregnancy and HIV prevention. Women were provided condoms, injectable DMPA, and/or FTC/TDF, according to their choices and underwent annual dual X-ray absorptiometry (DXA) scans. We used tenofovir-diphosphate (TFV-DP) quantification in dried blood spots and DMPA injection dates to classify exposure. Linear regression models estimated the difference in percent BMD change from baseline to month 12 for women using FTC/TDF and DMPA versus women using neither product.Results:Of 499 enrolled women, discontinuation and re-starting of contraception and PrEP was common. Women consistently using neither product (n = 39) experienced BMD increases. Women with consistent use of both products during 1 year (n = 22) experienced an average BMD loss of 1.04% at lumbar spine and hip and 1.77% at femoral neck. These losses were different relative to women who used neither agent: lumbar spine −3.35% (95% CI −5.13 to −1.56%, P = 0.001), total hip −2.24% (95% CI −3.87 to −0.60%, P = 0.009), and femoral neck −1.71% (95% CI −3.73 to 0.31%, P = 0.102).Conclusion:We observed a trend for women with concurrent DMPA and FTC/TDF PrEP use to have 1–3% lower BMD than unexposed women after 12 months.

01 Feb 2025·Contraception

Potential effect of immediate postpartum use of injectable contraception on lactogenesis

Article

Author: Dupper, Amy C ; Keder, Lisa ; Lawley, Megan ; Gallo, Maria F. ; Schumacher, Fernanda L ; Gallo, Maria F ; Keim, Sarah A ; Schumacher, Fernanda L. ; Keim, Sarah A. ; Dupper, Amy C.

OBJECTIVESWe evaluated the effect of immediate postpartum use of depot medroxyprogesterone acetate (DMPA) on the timing of lactogenesis stage II (LS-II).STUDY DESIGNThe initial design randomly assigned adults who delivered a full-term infant in 2019-2021 to receive within 48 hours of delivery: (1) DMPA, (2) placebo injection, or (3) no injection. Due to low enrollment, we changed in 2021-2023 to a nonrandomized design using matching at recruitment for obesity and delivery method and propensity score weighting for analysis. We combined data from both designs to compare immediate postpartum DMPA use (N = 55) vs control (placebo or no injection) group (N = 95). We defined noninferiority a priori as being met if the upper bound of a two-sided 95% CI for mean difference in time to LS-II between groups was <6 hours.RESULTSThe unweighted mean time to LS-II was 57.8 hours in the DMPA group (SD, 29.4) and 64.1 hours in the control group (SD, 36.1). Using propensity score weighting to make the groups comparable with respect to age, race, delivery method, and previous live births, the mean time to LS-II was 5.5 hours shorter (95% CI, -16.4, 5.5) for women in the DMPA relative to control group.CONCLUSIONSWe found no evidence that DMPA use inhibits the onset of LS-II. Findings support immediate postpartum DMPA initiation among those intending to engage in human milk feeding.IMPLICATIONSA controlled trial (N = 150) did not detect any difference in time to lactogenesis stage II ("milk let-down") between injectable contraception use within the first 48 hours postpartum and those without this exposure.

News (Medical) associated with Medroxyprogesterone Acetate

15 Jan 2025

·www.prnewswire.com

Depo-Provera Brain Tumor Litigation: All-Female Legal Team Takes on Devastating Female Health Issue

MINNEAPOLIS, Jan. 15, 2025 /PRNewswire/ -- National personal injury law firm Pritzker Hageman has assembled an all-female legal team to pursue litigation on behalf of women who developed meningioma tumors after using Depo-Provera birth control injections. Attorneys Alicia Penner and Morgan Vanden Heuvel are currently representing a South Dakota woman who developed multiple meningiomas following years of receiving Depo-Provera injections. Penner and Vanden Heuvel are urging women who received at least two Depo-Provera injections and were later diagnosed with a meningioma to contact them. Raising Awareness and Seeking Justice Penner and Vanden Heuvel stated that victims may be entitled to compensation for medical expenses, including surgeries and radiation therapy, as well as lost income, pain and suffering, and emotional distress related to symptoms such as paralysis, vision loss, seizures, cognitive decline, and debilitating headaches. Their client, who received Depo-Provera injections as prescribed, has suffered significant health consequences, including multiple surgeries, radiation treatment, vision loss, and other tumor-related impairments. Pritzker Hageman's Depo-Provera lawsuit team is committed to raising awareness among women across the country about the potential risks. "Depo-Shots" Linked to Tumor Growth Compelling scientific research shows that the extremely high doses of the synthetic progestin hormone in Depo-Provera can stimulate the growth of meningiomas. Depo-Provera was approved for contraceptive use in the United States in 1992, but studies going back to 1983 suggested that levels of synthetic progestin hormones found in Depo-Provera can bind to receptors on meningiomas, accelerating their growth. While these tumors are often called "benign," their location means they can compress the brain and spinal cord and lead to severe complications. Pritzker Hageman's Depo-Provera litigation aims to expose the fact that Pfizer and other companies failed to adequately warn women of the meningioma risk. "We want women to have awareness that users of Depo-Provera are at risk," Vanden Heuvel stated. "The longer you take it, the more likely it is that you would develop a brain tumor," Penner added. The potential number of women affected is substantial. In 2020, over 2 million prescriptions for Depo-Provera were written in the U.S. About Pritzker Hageman Pritzker Hageman is a nationally renowned law firm with a proven track record of successfully representing clients in complex personal injury and product liability cases. The firm is committed to holding corporations accountable for negligence and securing justice for those who have been harmed. Contact Alicia Penner 1-888-377-8900 [email protected] Morgan Vanden Heuvel 1-888-377-8900 [email protected] SOURCE Pritzker Hageman, P.A. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalRadiation TherapyPatent Infringement

07 Nov 2024

·www.businesswire.com

ViiV Healthcare expands on real-world data supporting use of long-acting therapies in diverse patient populations at HIV Glasgow

LONDON--( BUSINESS WIRE )--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will share new data from its industry-leading HIV treatment and prevention portfolio and pipeline at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November 2024. Spanning 42 abstracts, the data showcases long-acting and two-drug regimens as care options for diverse populations in the face of a continuing HIV epidemic. Harmony P. Garges, MD, Senior Vice President and Chief Medical Officer at ViiV Healthcare, said: “ViiV Healthcare is the first company to develop and launch long-acting options and two-drug regimens, and these therapies are transforming how physicians and providers treat and prevent HIV today. We continue evaluating how diverse populations living with or impacted by HIV respond to our therapies in the real world. Data from these studies include more than 10,000 people using Vocabria + Rekambys , more than 50,000 people using Dovato and more than 1,300 people using Apretude 1 . At HIV Glasgow, ViiV Healthcare is showcasing new, compelling data from our portfolio that reinforces how our medicines impact health outcomes and contribute to ending the HIV epidemic. ” Key data to be presented at HIV Glasgow 2024 by ViiV Healthcare and its study partners will include: Analysis of cabotegravir + rilpivirine long-acting (CAB+RPV LA) in the real-world and across phase 3/3b studies : Findings from a large-scale post hoc analysis of the complete long-acting HIV treatment regimen CAB+RPV LA will be presented. The analysis, which pooled data from over 2,500 participants across four major phase 3/3b clinical trials (FLAIR, ATLAS, ATLAS-2M, and SOLAR), will compare virologic outcomes and isolated viraemic events between daily oral HIV treatment and CAB+RPV LA. 2 Furthermore, the real-world utilisation of CAB+RPV LA will be explored in an analysis of adherence and persistence in a Canadian patient support program. These analyses will add to the growing body of clinical and real-world evidence for CAB+RPV LA and offer additional insights to healthcare providers on outcomes for CAB+RPV LA in diverse populations. Data exploring the use of dolutegravir/lamivudine (DTG/3TC) in antiretroviral-naïve people living with HIV: Findings will be presented from the Fundación Huésped-sponsored DOLCE study. This is the first study to fully focus on evaluating the efficacy and safety of the 2-drug regimen DTG/3TC in people living with HIV with CD4 ≤ 200 cells/mm³. 3 Additionally, data will be shared from the phase IV D2ARLING study, which compared the efficacy and safety of DTG/3TC against a 3-drug regimen in an antiretroviral-naïve population that did not have baseline drug-resistance testing results available. 4 Many guidelines recommend baseline drug resistance testing prior to antiretroviral therapy (ART) initiation, that may not always be readily accessible, reinforcing the need and impact of these data in an antiretroviral-naïve population. Cost-effectiveness and usage patterns for long-acting HIV prevention: Findings from a cost-effectiveness study examining the economic and public-health impact of cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in Canada will be presented. Researchers will compare the impact of the introduction of CAB LA for PrEP against daily oral PrEP (TDF/FTC) and no PrEP usage on cost savings and quality-adjusted life years. 5 New findings from the PROTECT survey will be shared, exploring differences in interest and intention to use long-acting PrEP among men who have sex with men and heterosexual men and women in 20 European countries. 6,7 Advancing novel mechanisms of action in HIV research: New findings from the BANNER study of VH3810109 (N6LS), an investigational, broadly neutralising antibody (bNAb), will be presented. Previously presented phase IIa proof-of-concept findings from the BANNER study suggested VH109 was well-tolerated and efficacious in people living with HIV. 8 Researchers will share new findings exploring the correlation between baseline phenotypic sensitivity to N6LS and virologic response after treatment with N6LS. 9 Additional research evaluating N6LS will focus on administration and dose responsiveness, adding to the growing body of evidence supporting the bNAb as a potential new approach to treating HIV. 10 ViiV Healthcare-sponsored or supported studies to be presented at HIV Glasgow 2024: Title First Author Presentation Cabotegravir + rilpivirine long-acting Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies J. Thornhill Poster Presentation Real-world utilization of cabotegravir/rilpivirine: an observational analysis of adherence and persistence using a patient support program in Canada, preliminary results C. LaForty Poster Presentation Feasibility and satisfaction of interventions measures (FIM and HIVTISQ) of implementation long-acting (LA) CAB+RPV administration out of HIV units: the IMADART study A. Cabello Poster Presentation Cabotegravir and rilpivirine concentrations and HIV-1 RNA suppression in male and female genital fluids and rectal tissue in people with HIV on antiretroviral therapy with long-acting intramuscular cabotegravir plus rilpivirine A. Fernández Oral Presentation Use of long-acting cabotegravir and rilpivirine in a real-life setting: 12-month results of virological outcome, adherence, safety, durability, in the ANRS CO3 AquiVIH-NA cohort-France M. Hessamfar Poster Presentation Results at month 7 of CABO-CHANCE study: real-world-evidence (RWE) on the use of intramuscular cabotegravir plus rilpivirine long-acting (CAB+RPV LA) dosed every 2 months in viral suppressed people with HIV (PWH) C. H. Tenorio Poster Presentation Re-suppression regimens and outcomes after virological failure in randomised controlled trials and real-world evidence studies evaluating cabotegravir and rilpivirine (CAB+RPV) A. Elias Poster Presentation Virological failure rate and emergent resistance in real-world studies evaluating long-acting cabotegravir and rilpivirine in people with baseline viral suppression M. Smuk Poster Presentation Cabotegravir long-acting for PrEP PrEP-associated stigma in Europe: findings from a real-world survey M. Schroeder Poster Presentation Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada A. Adelakun Poster Presentation Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used pre-exposure prophylaxis in Europe; the PrEPaRe study V. Cambiano Poster Presentation Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis H. Wang Oral Presentation Preparing for long-acting PrEP delivery: provider preferences for the provision of long-acting PrEP differ between MSM and heterosexual individuals in Europe H. M. L. Zimmerman Poster Presentation Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey K. Jonas Poster Presentation Dolutegravir Two-year long-term data on the efficacy and tolerability of dolutegravir-based regimens from the prospective multi-centre TESLA cohort study in ART-naive and pre-treated people living with HIV in Russia A. Basova Poster Presentation The analysis of metabolic parameters in people living with HIV using dolutegravir-based regimens in routine clinical practice in Russia A. Basova Poster Presentation Outcomes following prenatal exposure to DTG-containing antiretroviral therapy regimens: data from the DOLOMITE-EPPICC study R. Sconza Poster Presentation Incident hypertension with antiretroviral therapy: real-world evidence from the OPERA cohort P. Lackey Poster Presentation A multicentre observational study to determine the safety and effectiveness of dolutegravir (DTG) use during pregnancy: data from DOLOMITE-NEAT ID Network study J. D. Kowalska Poster Presentation Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia E. Tusch Poster Presentation Mental health in PWH: Patient-reported outcomes in the DUALIS study E. Wolf Poster Presentation Evaluating the cardiovascular risk and the achievement of target levels in low-density lipoprotein cholesterol in PLWH: Insights from the DUALIS study F. Voit Poster Presentation Dolutegravir-based antiretroviral therapy does not reduce plasma levonorgestrel or medroxyprogesterone acetate concentrations among contraceptive users living with HIV compared with HIV-negative controls R. Ryan Poster Presentation Efficacy and safety of dolutegravir (DTG)-based antiretroviral treatment (ART) in patients with HIV and solid organ transplantation (SOT): A single-arm clinical trial (DTG-SOT) J. Miro Poster Presentation Dolutegravir/lamivudine PAIRED - PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine (DTG/3TC): a sub-analysis of people with HIV (PWH) switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in the United States (US) J. Slim Poster Presentation Treatment-emergent integrase strand transfer inhibitor (INSTI) resistance-associated mutations among people living with HIV-1 treated with dolutegravir (DTG) + lamivudine (3TC) with pre-existing M184V/I from real-world and interventional studies D. Fox Poster Presentation An EYEWITNESS to successful diversity in antiretroviral switch studies C. V. Dam Poster Presentation CARAVEL: evaluation of real-world effectiveness and sustainability of the 2-drug regimen dolutegravir/lamivudine fixed-dose combination in treatment-naive adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France. Two-year interim analysis results P. Philibert Poster Presentation Real world experience of DTG+3TC regimen: results from the French Dat'AIDS cohort (2015-2022) C. Allavena Poster Presentation Changes in patient-reported neuropsychological outcomes in virologically suppressed persons with HIV switching to DTG/3TC or BIC/FTC/TAF: a substudy of the PASO-DOBLE randomized clinical trial L. Garcia-Fraile Poster Presentation Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm 3 : the DOLCE study M. I. Figueroa Oral Presentation RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF S. Degroote Poster Presentation Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study E. Cordova Poster Presentation Long-term efficacy and safety of Dolutegravir/Lamivudine in virologically suppressed persons with resistance to Lamivudine: Week 96 results of VOLVER clinical trial - GESIDA 11820 M. De Lagarde Poster Presentation Fostemsavir CD4 T-cell, CD4/CD8 ratio improvement and a general reduction in inflammatory biomarkers with low-level viremia (LLV) up to Week 192 with fostemsavir (FTR)-based regimens in individuals with multidrug-resistant (MDR) HIV-1 V. Spagnuolo Encore Poster Presentation Similar efficacy, safety and CD4 T-cell increase up to Week 96 observed with fostemsavir (FTR)-based regimens in the BRIGHTE study and dolutegravir (DTG)-based regimens in the VIKING-3 study in individuals with multidrug-resistant (MDR) HIV-1 A. Castagna Encore Poster Presentation Pipeline Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER M. Gartland Poster Presentation VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models M. Keegan Encore Poster Presentation Additional Studies Mortality and clinical outcomes after common cancers in people A. Timiryasova Poster Presentation The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study S. Deb Poster Presentation Comparison of 4 frailty scores to predict adverse health outcomes and mortality in people living with HIV aged 70 years and more (ANRS EP66 SEPTAVIH study) C. Allavena Poster Presentation The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period L. Sukumaran Poster Presentation About Dovato Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato . Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets . About Vocabria Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class. Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing. Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets About Rekambys Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection About Apretude Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Fundación Huésped Fundación Huésped is an Argentine organisation with a regional reach that has been working in public health since 1989, aiming to ensure the right to health and the control of diseases are guaranteed. Our comprehensive approach includes the development of research, practical solutions, and communications related to public health policies in our country and the region. Our mission is to conduct scientific research and implement preventive actions and rights-promotion initiatives to ensure access to healthcare and reduce the impact of diseases, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable diseases, and other transmissible diseases, as well as sexual and reproductive health. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com . About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References: 1 Data on file 2 J. Thornhill, et al . Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 3 M. I. Figueroa, et al . Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 4 E. Cordova, et al . Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 5 A. Adelakun, et al . Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 6 H. Wang, et al . Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 7 K. Jonas, et al. Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 8 P. Leone, et. al . VH3810109 (N6LS) Reduces Viremia Across a Range of Doses in ART-Naive Adults Living with HIV: Proof of Concept Achieved in the Phase IIa BANNER (207959, NCT04871113) Study. Presented at HIV Glasgow 2022, 23 – 26 October, Glasgow, Scotland. 9 M. Gartland, et al . Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. 10 M. Keegan, et al . VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland. For media and investors only

Phase 2Clinical ResultPhase 3

23 May 2024

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Certain menopausal hormone therapy could raise ovarian cancer risk, study finds

An older form of hormone therapy taken to ease the symptoms of menopause could increase the risk of ovarian cancer, according to results released Thursday from two studies involving tens of thousands of women. Another hormonal regimen didnt seem to carry this same risk, researchers found.The results should help settle debate over the relative risk of cancer associated with estrogen- and progestin-based hormonal therapy. Still, researchers noted, the absolute risk of ovarian cancer associated with either regimen is low.Before these randomized, placebo-controlled clinical trials, observational studies examining the influence of estrogen plus progestin on ovarian and endometrial cancers gave mixed results, said Rowan Chlebowski, of the Lundquist Institute in California, in a statement on the findings. Our study provides the only long-term information from a randomized clinical trial on two common cancers in postmenopausal women for two of the most commonly used medications.Part of the Womens Health Initiative that began in 1991, the studies ran between 1993 and 1998 and enrolled more than 27,000 women aged 50 to 79 years from across the U.S. The findings, which stem from a 20-year follow-up analysis, will be presented at the American Society of Clinical Oncologys annual meeting, being held in Chicago from May 31 to June 4.For postmenopausal women, hormone therapy has long been used to help manage hot flashes and sleep disturbances. During the time of the studies, the standard option for women who had had a hysterectomy, or their uteruses removed, was conjugated equine estrogen, or CEE. Women who still had a uterus often received CEE plus medroxyprogesterone acetate, or MPA.The WHI studies randomized women without a uterus to either CEE or a placebo, and those who had a uterus to receive CEE plus MPA or a placebo.Results show that CEE was associated with a higher risk of developing ovarian cancer compared to placebo, with 35 cases in the hormone therapy group versus 17 in the placebo group. The risk of dying from ovarian cancer was almost three times higher with among CEE-treated women than in those given placebo.But among women with uteruses who took CEE plus MPA, there was no statistically significant increase in the risk of developing ovarian cancer, or in dying from it. Notably, women on this regimen had a 28% lower risk of developing uterine cancer, researchers found.While this new information is an important part of patient counseling and education, given the low numbers, it should not necessarily impact a woman's decision to take menopausal hormone therapy for symptomatic relief of menopausal symptoms, said Eleonora Teplinsky, a physician at Valley Mount Sinai Comprehensive Cancer Care, in a statement provided by ASCO.CEE was for years a common menopausal treatment. But its use declined following prior WHI findings on associated heart risks that led to Food and Drug Administration warnings.Hormonal therapy is not currently recommended for all postmenopausal women. Groups like the American Cancer Society have previously flagged ovarian cancer risk, while the FDA has highlighted the risk of endometrial cancer. The regulator advises women who do take hormonal therapy for menopausal symptoms to use the lowest dose for as short a time as possible.However, WHI researchers noted that ovarian cancer is not currently incorporated as a risk in prescribing guidelines for menopausal hormone therapy. They also suggested that their findings prompt reconsideration of advice around estrogen-only use in ovarian cancer survivors.Some drugmakers, meanwhile, are developing non-hormonal medications that could become an alternative to hormone therapy for treating vasomotor symptoms. '

Clinical ResultASCO

100 Deals associated with Medroxyprogesterone Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D00951	Medroxyprogesterone Acetate	L02AB02 G03AC06 G03DA02	DB00603

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Approved

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Indication	Country/Location	Organization	Date
Suppression of ovulation	JP	Kyowa Kirin Co., Ltd.	11 Mar 2022
Pain	US	Pfizer Inc.	04 Dec 2020
Contraception	US	Pfizer Inc.	17 Dec 2004
Pregnancy	US	Pfizer Inc.	29 Oct 1992
Breast Cancer	CN	Xi'an Lijun Pharmaceutical Co., Ltd.	01 Jan 1982
Endometrial Carcinoma	CN	Xi'an Lijun Pharmaceutical Co., Ltd.	01 Jan 1982
Prostatic Cancer	CN	Xi'an Lijun Pharmaceutical Co., Ltd.	01 Jan 1982
Renal Cell Carcinoma	CN	Xi'an Lijun Pharmaceutical Co., Ltd.	01 Jan 1982
Abortion, Habitual	JP	Pfizer Japan, Inc.	25 Jan 1963
Abortion, Threatened	JP	Pfizer Japan, Inc.	25 Jan 1963
Hypomenorrhea	JP	Pfizer Japan, Inc.	25 Jan 1963
Infertility	JP	Pfizer Japan, Inc.	25 Jan 1963
Menorrhagia	JP	Pfizer Japan, Inc.	25 Jan 1963
Menstruation Disturbances	JP	Pfizer Japan, Inc.	25 Jan 1963
Amenorrhea	US	Pfizer Inc.	18 Jun 1959
Endometrial Hyperplasia	US	Pfizer Inc.	18 Jun 1959
Metrorrhagia	US	Pfizer Inc.	18 Jun 1959

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 1	CN	Tianjin Pharm Research Inst Pharm Co Ltd.	11 Dec 2019
Eczema	Phase 1	CN	Tianjin Pharm Research Inst Pharm Co Ltd.	11 Dec 2019
Neurodermatitis	Phase 1	CN	Tianjin Pharm Research Inst Pharm Co Ltd.	11 Dec 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02550067 (ECHO, Pubmed \| BMC Womens Health) Manual	Not Applicable	Contraception	398	Depot medroxyprogesterone acetate (DMPA-IM)	(gtobqasnmy) = rzgaavnbro uhhykriber (eicdcdhpbx ) View more	Positive	08 Mar 2024
				copper intrauterine device	(gtobqasnmy) = ozjrfsaojf uhhykriber (eicdcdhpbx ) View more
NCT02550067 (Pubmed \| Clin Infect Dis)	Not Applicable	Herpes Simplex	4,062	Depot medroxyprogesterone acetate (DMPA-IM)	btioblpgcn(vxzbagvolw) = fecygwmade bwhitttmll (zlxveadbqf )	-	10 Sep 2022
				Levonorgestrel (LNG) implant	btioblpgcn(vxzbagvolw) = mvmlxhbqmq bwhitttmll (zlxveadbqf )
NCT02122198 (CTgov)	Not Applicable	Cognitive Dysfunction \| Endothelial dysfunction \| Impairment of Executive Functions	17	Placebo (Placebo)	usdlxidpwh(qlezgeoenn) = bbinlqdxtz pdmxahnjtx (qcujvlwkbx, ydrpffarby - svhfqzbalm) View more	-	10 Jan 2022
				Medroxyprogesterone+Leuprolide acetate+Estradiol (GnRH Agonist)	usdlxidpwh(qlezgeoenn) = osloqfejoq pdmxahnjtx (qcujvlwkbx, ibmxvatmbt - kegcfvrrsl) View more
NCT03018249 (CTgov)	Early Phase 1	Endometrial Endometrioid Adenocarcinoma	50	Medroxyprogesterone Acetate (Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA)	owrwrwbjmo(xixrinfxzd) = arwmqbmfbe ypdgoaktep (aqbvsfqkiw, ivtdlaqwlg - glurnuxwsu) View more	-	02 Jun 2021
				Medroxyprogesterone Acetate+Entinostat+MPA (Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat)	owrwrwbjmo(xixrinfxzd) = uldzsbikqn ypdgoaktep (aqbvsfqkiw, huxsfadyqq - xfjsffjoxd) View more
NCT02550067 (ECHO trial, IAS2021)	Not Applicable	Urogenital infection by Trichomonas vaginalis \| Mycoplasma genitalium infection	458	DMPA-IM	xaohjepygm(tlsedpnypv) = dluhoxccme altgexerss (atuqvmttti ) View more	-	01 Jan 2021
				Copper IUD	bqowqwkvtw(uvfsvlgdrb) = kkethlrxxv klwekebduh (carkzzxadl )
NCT00997893 (RISE, CTgov)	Phase 2	Menopausal symptoms \| Hot Flashes	96	Soy Placebo+Medroxyprogesterone Acetate (MPA)+Estradiol (Estradiol/Medroxyprogesterone Acetate)	rcwxmxucal(gucsqrxwgn) = vavcqssnrq glwcxaqtih (pephipltku, dvpvszlqml - secuxmovai) View more	-	07 Dec 2020
				Soy Placebo (Placebo)	rcwxmxucal(gucsqrxwgn) = zpsvknsrqv glwcxaqtih (pephipltku, ciuedxpvje - lqjtwqjcyw) View more
NCT02357368 (CTgov)	Phase 4	HIV Infections \| Contraception	59	Depot medroxyprogesterone acetate (DMPA) (Depot Medroxyprogesterone Acetate (DMPA))	scpjyylpjh(bygifuddxr) = uhfwqlkryq icjkrbpzna (utqwrdhkmk, uahmnbkiis - xmfwvsfflm) View more	-	18 Nov 2020
				Levonorgestrel intrauterine device (Lng-IUD) (Levonorgestrel Intrauterine Device (Lng-IUD))	scpjyylpjh(bygifuddxr) = losgtopeje icjkrbpzna (utqwrdhkmk, fuovgvlvry - kbidwurote) View more
NCT02509767 (DSAS, CTgov)	Phase 4	Contraception	401	Subcutaneous depot medroxyprogesterone acetate (Self-Administration)	smzghlmrls(pvfahwmcij) = dcsomtzmro wzmphqpzpp (zmnfrkbtwh, yohxtxpsxc - ffdhraihqs) View more	-	18 Sep 2019
				Subcutaneous depot medroxyprogesterone acetate (Clinic Administration (Standard Care))	smzghlmrls(pvfahwmcij) = junpmykqni wzmphqpzpp (zmnfrkbtwh, zznkfylmpa - nqpliywynl) View more
NCT02796105 \| EUCTR2015-004328-73-ES (Pubmed \| Hum Reprod)	Phase 4	-	252	Medroxyprogesterone acetate	rjvmnxdbrb(suukgyrtkp) = tpqjbxisac rqtyvkqeku (gmcvcwnlqo ) View more	-	01 May 2019
				Ganirelix	rjvmnxdbrb(suukgyrtkp) = qhsvbdaixc rqtyvkqeku (gmcvcwnlqo ) View more
NCT02412436 (PRIDE-HT, CTgov)	Phase 2	Tuberculosis \| HIV Infections	62	Depot medroxyprogesterone acetate	unhdgookrm(jilxqussqy) = rzffxeamar kyetvgieku (xvhempncbr, aouqcyinyb - chkrymullz) View more	-	25 Sep 2018

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