16 research outputs found

    Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.

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    BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding. METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal add-back therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone group was included to assess the impact of add-back therapy on the hypoestrogenic effects of elagolix. The primary end point was menstrual blood loss of less than 80 ml during the final month of treatment and at least a 50% reduction in menstrual blood loss from baseline to the final month; missing data were imputed with the use of multiple imputation. RESULTS: A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P CONCLUSIONS: Elagolix with add-back therapy was effective in reducing heavy menstrual bleeding in women with uterine fibroids. (Funded by AbbVie; Elaris UF-1 and Elaris UF-2 ClinicalTrials.gov numbers, NCT02654054 and NCT02691494.)

    Empowerment Feminist Therapy with Latina Immigrants: Honoring the Complexity and Socio-Cultural Contexts of Clients\u27 Lives

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    In this article, we present how empowerment feminist therapy (EFT) can be effectively used with Latina immigrant clients. A key idea anchoring the arguments is the need for therapists to use a complex conceptual framework and a contextual perspective in understanding clients’ experiences. A brief description of the psychological stressors experienced by women immigrants from Latin America to the United States is presented. Principles of EFT are discussed with specific emphasis on how these apply to therapy with Latina immigrants. We argue that EFT can be effectively used with Latina immigrants as long as therapists take into consideration the complexity and cultural context of their lives

    Accountability and Single-Sex Schooling: A Collision of Reform Agendas

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    This ethnographic study documents how accountability measures skewed the implementation of gender equity reform at one California public middle school serving low-income students of color. In creating single-sex classes throughout the school, the Single Sex Academy (SSA) became the largest public experiment with single-sex schooling in the country, but pressure to raise its standardized test scores diverted the school away from the exploration and implementation of the gender reform. The chronicle of SSA is particularly relevant in light of (a) a recent call to relax Title IX standards and increase the numbers of public single-sex classes and schools, and (b) the provision of monies mandated by the No Child Left Behind Act of 2001 for single-sex classes and schools, along with the act\u27s imposition of accountability standards and testing
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