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[PMID]: 28732067 [Au] Autor: Hasegawa S; Matsui T; Hane Y; Abe J; Hatahira H; Motooka Y; Sasaoka S; Fukuda A; Naganuma M; Hirade K; Takahashi Y; Kinosada Y; Nakamura M [Ad] Endereço: Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan. [Ti] Título: Thromboembolic adverse event study of combined estrogen-progestin preparations using Japanese Adverse Drug Event Report database. [So] Source: PLoS One;12(7):e0182045, 2017. [Is] ISSN: 1932-6203 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: Combined estrogen-progestin preparations (CEPs) are associated with thromboembolic (TE) side effects. The aim of this study was to evaluate the incidence of TE using the Japanese Adverse Drug Event Report (JADER) database. Adverse events recorded from April 2004 to November 2014 in the JADER database were obtained from the Pharmaceuticals and Medical Devices Agency (PMDA) website (www.pmda.go.jp). We calculated the reporting odds ratios (RORs) of suspected CEPs, analyzed the time-to-onset profile, and assessed the hazard type using Weibull shape parameter (WSP). Furthermore, we used the applied association rule mining technique to discover undetected relationships such as the possible risk factors. The total number of reported cases in the JADER contained was 338,224. The RORs (95% confidential interval, CI) of drospirenone combined with ethinyl estradiol (EE, Dro-EE), norethisterone with EE (Ne-EE), levonorgestrel with EE (Lev-EE), desogestrel with EE (Des-EE), and norgestrel with EE (Nor-EE) were 56.2 (44.3-71.4), 29.1 (23.5-35.9), 42.9 (32.3-57.0), 44.7 (32.7-61.1), and 38.6 (26.3-56.7), respectively. The medians (25%-75%) of the time-to-onset of Dro-EE, Ne-EE, Lev-EE, Des-EE, and Nor-EE were 150.0 (75.3-314.0), 128.0 (27.0-279.0), 204.0 (44.0-660.0), 142.0 (41.3-344.0), and 16.5 (8.8-32.0) days, respectively. The 95% CIs of the WSP-ß for Ne-EE, Lev-EE, and Nor-EE were lower and excluded 1. Association rule mining indicated that patients with anemia had a potential risk of developing a TE when using CEPs. Our results suggest that it is important to monitor patients administered CEP for TE. Careful observation is recommended, especially for those using Nor-EE, and this information may be useful for efficient therapeutic planning. [Mh] Termos MeSH primário: Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética Estrogênios/administração & dosagem Estrogênios/efeitos adversos Progestinas/administração & dosagem Progestinas/efeitos adversos Tromboembolia/induzido quimicamente [Mh] Termos MeSH secundário: Adolescente Adulto Sistemas de Notificação de Reações Adversas a Medicamentos Androstenos/administração & dosagem Androstenos/efeitos adversos Criança Anticoncepcionais Orais Combinados/administração & dosagem Anticoncepcionais Orais Combinados/efeitos adversos Bases de Dados Factuais Desogestrel/administração & dosagem Desogestrel/efeitos adversos Etinilestradiol/administração & dosagem Etinilestradiol/efeitos adversos Feminino Seres Humanos Japão Levanogestrel/administração & dosagem Levanogestrel/efeitos adversos Masculino Meia-Idade Noretindrona/administração & dosagem Noretindrona/efeitos adversos Norgestrel/administração & dosagem Norgestrel/efeitos adversos Razão de Chances Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Androstenes); 0 (Contraceptives, Oral, Combined); 0 (Estrogens); 0 (Progestins); 3J8Q1747Z2 (Norgestrel); 423D2T571U (Ethinyl Estradiol); 5W7SIA7YZW (Levonorgestrel); 81K9V7M3A3 (Desogestrel); N295J34A25 (drospirenone); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1709 [Cu] Atualização por classe: 170925 [Lr] Data última revisão: 170925 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170722 [St] Status: MEDLINE [do] DOI: 10.1371/journal.pone.0182045

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[PMID]: 28542081 [Au] Autor: Balkus JE; Palanee-Phillips T; Reddy K; Siva S; Harkoo I; Nakabiito C; Kintu K; Nair G; Chappell C; Kiweewa FM; Kabwigu S; Naidoo L; Jeenarain N; Marzinke M; Soto-Torres L; Brown ER; Baeten JM [Ad] Endereço: *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; Departments of †Epidemiology; ‡Global Health, University of Washington, Seattle, WA; §Wits Reproductive Health and HIV Institute, Johannesburg, South Africa; ‖South African Medical Research Council, Durban, South Africa; ¶CAPRISA, Durban, South Africa; #Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda; **Emavundleni Research Centre, Cape Town, South Africa; ††Magee-Womens Hospital of UPMC, Pittsburgh, PA; ‡‡Departments of Pathology and Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; §§US National Institutes of Health, Bethesda, MD; and Departments of ‖‖Biostatistics; ¶¶Medicine, University of Washington, Seattle, WA. [Ti] Título: Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception. [So] Source: J Acquir Immune Defic Syndr;76(2):e47-e51, 2017 Oct 01. [Is] ISSN: 1944-7884 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: OBJECTIVE: To evaluate the potential for a clinically relevant drug-drug interaction with concomitant use of a dapivirine vaginal ring, a novel antiretroviral-based HIV-1 prevention strategy, and hormonal contraception by examining contraceptive efficacies with and without dapivirine ring use. DESIGN: A secondary analysis of women participating in MTN-020/ASPIRE, a randomized, double-blind, placebo-controlled trial of the dapivirine vaginal ring for HIV-1 prevention. METHODS: Use of a highly effective method of contraception was an eligibility criterion for study participation. Urine pregnancy tests were performed monthly. Pregnancy incidence by arm was calculated separately for each hormonal contraceptive method and compared using an Andersen-Gill proportional hazards model stratified by site and censored at HIV-1 infection. RESULTS: Of 2629 women enrolled, 2310 women returned for follow-up and reported using a hormonal contraceptive method at any point during study participation (1139 in the dapivirine arm and 1171 in the placebo arm). Pregnancy incidence in the dapivirine arm versus placebo among women using injectable depot medroxyprogesterone acetate was 0.43% vs. 0.54%, among women using injectable norethisterone enanthate was 1.15% vs. 0%, among women using hormonal implants was 0.22% vs. 0.69%, and among women using oral contraceptive pills was 32.26% vs. 28.01%. Pregnancy incidence did not differ by study arm for any of the hormonal contraceptive methods. CONCLUSIONS: Use of the dapivirine ring does not reduce the effectiveness of hormonal contraceptives for pregnancy prevention. Oral contraceptive pill use was associated with high pregnancy incidence, potentially because of poor pill adherence. Injectable and implantable methods were highly effective in preventing pregnancy. [Mh] Termos MeSH primário: Antirretrovirais/administração & dosagem Anticoncepção Anticoncepcionais Femininos/administração & dosagem Dispositivos Anticoncepcionais Femininos Pirimidinas/administração & dosagem [Mh] Termos MeSH secundário: Adolescente Adulto Antirretrovirais/farmacologia Anticoncepcionais Femininos/farmacologia Anticoncepcionais Orais Hormonais/administração & dosagem Anticoncepcionais Orais Hormonais/farmacologia Método Duplo-Cego Interações Medicamentosas Feminino Seguimentos Infecções por HIV/tratamento farmacológico Infecções por HIV/prevenção & controle Seres Humanos Incidência Acetato de Medroxiprogesterona/administração & dosagem Acetato de Medroxiprogesterona/farmacologia Meia-Idade Noretindrona/administração & dosagem Noretindrona/análogos & derivados Noretindrona/farmacologia Gravidez Pirimidinas/farmacologia Adulto Jovem [Pt] Tipo de publicação: CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Anti-Retroviral Agents); 0 (Contraceptive Agents, Female); 0 (Contraceptives, Oral, Hormonal); 0 (Pyrimidines); C2QI4IOI2G (Medroxyprogesterone Acetate); HY3S2K0J0F (norethindrone enanthate); T18F433X4S (Norethindrone); TCN4MG2VXS (Dapivirine) [Em] Mês de entrada: 1709 [Cu] Atualização por classe: 171116 [Lr] Data última revisão: 171116 [Sb] Subgrupo de revista: IM; X [Da] Data de entrada para processamento: 170526 [St] Status: MEDLINE [do] DOI: 10.1097/QAI.0000000000001455

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[PMID]: 28189123 [Au] Autor: Zitzmann M; Rohayem J; Raidt J; Kliesch S; Kumar N; Sitruk-Ware R; Nieschlag E [Ad] Endereço: Institute of Reproductive Medicine, University Clinics, Muenster, Germany. [Ti] Título: Impact of various progestins with or without transdermal testosterone on gonadotropin levels for non-invasive hormonal male contraception: a randomized clinical trial. [So] Source: Andrology;5(3):516-526, 2017 May. [Is] ISSN: 2047-2927 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Although several progestins have been tested for hormonal male contraception, the effects of dosage and nature of various progestins on gonadotropin suppression combined with and without additional testosterone has not been performed in a comparative trial. The aim of this study was to evaluate the differential impact of four oral or transdermal progestins on the suppression of gonadotropins in healthy men: oral: cyproterone acetate (CPA), levonorgestrel (LNG), norethisterone acetate (NETA), and transdermal: Nestorone (NES), all in combination with transdermal testosterone (T). Randomized clinical trial testing was performed with four progestins at two doses each. After a 2-week progestin-only treatment, transdermal T was added for further 4 weeks and was followed by a 3-week recovery period. Progestin-dose per day: CPA 10 mg/20 mg, NES 2 mg/3 mg/dose e.g. 200/300 µg/day absorbed, NETA 5 mg/10 mg, LNG 120 µg/240 µg. From an andrology outpatient clinic, 56 healthy men aged 18-50 years, with body mass index ≤33 kg × m were included in the study. Serum concentrations of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) were studied. Secondary outcome measure included were serum testosterone concentrations, sperm concentrations, and safety parameters. Intergroup comparisons demonstrated that CPA and LNG had the strongest effect on LH/FSH suppression. Nevertheless, every substance showed significant inhibitory effects on gonadotropin secretion, especially in combination with transdermal T. A decrease in hematocrit and insulin sensitivity as well as cholesterol subfractions and triglycerides was uniformly seen for every group. The combination of oral or transdermal progestins with a transdermal testosterone preparation is able to suppress gonadotropins. Further dose titration studies with sperm suppression as an end-point should be conducted to determine the lowest effective dose for hormonal male contraception. [Mh] Termos MeSH primário: Anticoncepcionais Masculinos/administração & dosagem Acetato de Ciproterona/administração & dosagem Levanogestrel/administração & dosagem Noretindrona/análogos & derivados Norprogesteronas/administração & dosagem Testosterona/administração & dosagem [Mh] Termos MeSH secundário: Adolescente Adulto Anticoncepção/métodos Anticoncepcionais Masculinos/efeitos adversos Acetato de Ciproterona/efeitos adversos Hormônio Foliculoestimulante/sangue Seres Humanos Levanogestrel/efeitos adversos Hormônio Luteinizante/sangue Masculino Meia-Idade Noretindrona/administração & dosagem Noretindrona/efeitos adversos Norprogesteronas/efeitos adversos Progestinas Espermatozoides/efeitos dos fármacos Testosterona/efeitos adversos Testosterona/sangue Adesivo Transdérmico Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Contraceptive Agents, Male); 0 (Norprogesterones); 0 (Progestins); 3XMK78S47O (Testosterone); 4KM2BN5JHF (Cyproterone Acetate); 5W7SIA7YZW (Levonorgestrel); 7759-35-5 (ST 1435); 9002-67-9 (Luteinizing Hormone); 9002-68-0 (Follicle Stimulating Hormone); 9S44LIC7OJ (norethindrone acetate); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1704 [Cu] Atualização por classe: 171006 [Lr] Data última revisão: 171006 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170212 [St] Status: MEDLINE [do] DOI: 10.1111/andr.12328

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[PMID]: 28162779 [Au] Autor: Casper RF [Ad] Endereço: Division of Reproductive Sciences, University of Toronto, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, and TRIO Fertility, Toronto, Ontario, Canada. Electronic address: casper@lunenfeld.ca. [Ti] Título: Progestin-only pills may be a better first-line treatment for endometriosis than combined estrogen-progestin contraceptive pills. [So] Source: Fertil Steril;107(3):533-536, 2017 Mar. [Is] ISSN: 1556-5653 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: For decades, combined estrogen-progestin oral contraceptive pills (OCPs) have been the first-line treatment for menstrual and pelvic pain associated with endometriosis without any clinical evidence of efficacy. Initial relief provided by OCPs is likely a result of improvement in primary dysmenorrhea. Biologic data and limited clinical evidence support a potential adverse effect of long-term use of OCPs on the progression of endometriosis. In contrast, there is randomized, controlled trial data to support the use of oral progestin-only treatment for pelvic pain associated with endometriosis and for suppressing the anatomic extent of endometriotic lesions. Both norethindrone acetate and dienogest have regulatory approval for treating endometriosis and may be better than OCPs as a first-line therapy. [Mh] Termos MeSH primário: Anticoncepcionais Orais Combinados/administração & dosagem Anticoncepcionais Orais Hormonais/administração & dosagem Endometriose/tratamento farmacológico Endométrio/efeitos dos fármacos Nandrolona/análogos & derivados Noretindrona/análogos & derivados Dor Pélvica/tratamento farmacológico Progestinas/administração & dosagem [Mh] Termos MeSH secundário: Administração Oral Anticoncepcionais Orais Combinados/efeitos adversos Anticoncepcionais Orais Hormonais/efeitos adversos Endometriose/diagnóstico Endometriose/fisiopatologia Endométrio/patologia Endométrio/fisiopatologia Feminino Seres Humanos Ciclo Menstrual/efeitos dos fármacos Nandrolona/administração & dosagem Nandrolona/efeitos adversos Noretindrona/administração & dosagem Noretindrona/efeitos adversos Dor Pélvica/diagnóstico Dor Pélvica/fisiopatologia Progestinas/efeitos adversos Resultado do Tratamento [Pt] Tipo de publicação: JOURNAL ARTICLE; REVIEW [Nm] Nome de substância: 0 (Contraceptives, Oral, Combined); 0 (Contraceptives, Oral, Hormonal); 0 (Progestins); 46M3EV8HHE (dienogest); 6PG9VR430D (Nandrolone); 9S44LIC7OJ (norethindrone acetate); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170605 [Lr] Data última revisão: 170605 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170207 [St] Status: MEDLINE

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[PMID]: 28024920 [Au] Autor: Brady PC; Missmer SA; Laufer MR [Ad] Endereço: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; Division of Gynecology, Department of Surgery, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts; Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: pbrady2@partners.org. [Ti] Título: Hepatic Adenomas in Adolescents and Young Women with Endometriosis Treated with Norethindrone Acetate. [So] Source: J Pediatr Adolesc Gynecol;30(3):422-424, 2017 Jun. [Is] ISSN: 1873-4332 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: BACKGROUND: Endometriosis-ectopic implantation of endometrial-like tissue-affects 10% of female adolescents and adults. First-line treatment includes progesterone only (such as norethindrone acetate [NET-A]) or combined estrogen/progestin oral contraceptive pills. Estrogen-containing contraceptives confer increased risk of hepatic adenomas, whereas the association with NET-A is very rarely reported. CASE: Three adolescents with stage I to II endometriosis managed with NET-A (up to 15 mg/d for 28-78 months) were diagnosed with hepatic adenomas at ages 17-22 years. They previously received estrogen-containing medications, which were stopped 24 months or longer before diagnosis of hepatic adenoma. SUMMARY AND CONCLUSION: NET-A in a dose greater than 10 mg/d might be associated with increased risk for hepatic adenomas, likely due to peripheral conversion to ethinyl estradiol. Use of NET-A might not be advisable in patients with known hepatic adenomas. [Mh] Termos MeSH primário: Adenoma/epidemiologia Anticoncepcionais Orais Hormonais/efeitos adversos Endometriose/tratamento farmacológico Neoplasias Hepáticas/epidemiologia Noretindrona/análogos & derivados [Mh] Termos MeSH secundário: Adenoma/induzido quimicamente Adolescente Adulto Anticoncepcionais Orais Hormonais/uso terapêutico Etinilestradiol/administração & dosagem Feminino Seres Humanos Neoplasias Hepáticas/induzido quimicamente Imagem por Ressonância Magnética Noretindrona/efeitos adversos Noretindrona/uso terapêutico Adulto Jovem [Pt] Tipo de publicação: CASE REPORTS; JOURNAL ARTICLE [Nm] Nome de substância: 0 (Contraceptives, Oral, Hormonal); 423D2T571U (Ethinyl Estradiol); 9S44LIC7OJ (norethindrone acetate); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1709 [Cu] Atualização por classe: 170907 [Lr] Data última revisão: 170907 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161228 [St] Status: MEDLINE

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[PMID]: 27809666 [Au] Autor: Etchells DB; Brooks JL; Johnston RA [Ad] Endereço: a Centre for Cognitive Neuroscience and Cognitive Systems, School of Psychology , University of Kent , Canterbury , UK. [Ti] Título: Evidence for view-invariant face recognition units in unfamiliar face learning. [So] Source: Q J Exp Psychol (Hove);70(5):874-889, 2017 May. [Is] ISSN: 1747-0226 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Many models of face recognition incorporate the idea of a face recognition unit (FRU), an abstracted representation formed from each experience of a face which aids recognition under novel viewing conditions. Some previous studies have failed to find evidence of this FRU representation. Here, we report three experiments which investigated this theoretical construct by modifying the face learning procedure from that in previous work. During learning, one or two views of previously unfamiliar faces were shown to participants in a serial matching task. Later, participants attempted to recognize both seen and novel views of the learned faces (recognition phase). Experiment 1 tested participants' recognition of a novel view, a day after learning. Experiment 2 was identical, but tested participants on the same day as learning. Experiment 3 repeated Experiment 1, but tested participants on a novel view that was outside the rotation of those views learned. Results revealed a significant advantage, across all experiments, for recognizing a novel view when two views had been learned compared to single view learning. The observed view invariance supports the notion that an FRU representation is established during multi-view face learning under particular learning conditions. [Mh] Termos MeSH primário: Face Aprendizagem/fisiologia Reconhecimento Visual de Modelos/fisiologia Recognição (Psicologia)/fisiologia [Mh] Termos MeSH secundário: Adolescente Adulto Etinilestradiol Feminino Seres Humanos Masculino Noretindrona Estimulação Luminosa Tempo de Reação/fisiologia Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 37270-71-6 (norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination); 423D2T571U (Ethinyl Estradiol); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1703 [Cu] Atualização por classe: 170320 [Lr] Data última revisão: 170320 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161105 [St] Status: MEDLINE

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[PMID]: 26927501 [Au] Autor: Sadler Gallagher J; Feldman HA; Stokes NA; Laufer MR; Hornstein MD; Gordon CM; DiVasta AD [Ad] Endereço: Division of Adolescent Medicine, Boston Children's Hospital, Boston, Massachusetts; Boston Center for Endometriosis, Boston, Massachusetts. Electronic address: jenny.sadler@childrens.harvard.edu. [Ti] Título: The Effects of Gonadotropin-Releasing Hormone Agonist Combined with Add-Back Therapy on Quality of Life for Adolescents with Endometriosis: A Randomized Controlled Trial. [So] Source: J Pediatr Adolesc Gynecol;30(2):215-222, 2017 Apr. [Is] ISSN: 1873-4332 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: STUDY OBJECTIVE: Use of gonadotropin-releasing hormone agonists (GnRHa) to treat endometriosis can cause mood and vasomotor side effects. "Add-back therapy," the combination of low-dose hormones, limits side effects but research is limited to adults. We sought to characterize quality of life (QOL) before treatment and to compare an add-back regimen of norethindrone acetate (NA) with conjugated estrogens (CEE) to NA alone for preventing side effects of GnRHa therapy in female adolescents with endometriosis. DESIGN: Twelve-month double-blind, placebo-controlled trial. SETTING: Pediatric Gynecology clinic in Boston, Massachusetts. PARTICIPANTS: Fifty female adolescents (aged 15-22 years) with surgically confirmed endometriosis initiating treatment with GnRHa. INTERVENTIONS: Subjects were randomized to: NA (5 mg/d) with CEE (0.625 mg/d) or NA (5 mg/d) with placebo. All subjects received leuprolide acetate depot every 3 months. MAIN OUTCOME MEASURES: The Short Form-36 v2 Health Survey, Beck Depression Inventory II, and Menopause Rating Scale were completed at repeated intervals. RESULTS: At baseline, subjects reported impaired physical health-related QOL compared with national norms (all P < .0001). Over 12 months, these Short Form-36 v2 scores improved (all P < .05). Subjects receiving NA with CEE showed greater improvements in the pain, vitality, and physical health subscales (P < .05) than those receiving NA alone, as well as better physical functioning (P < .05). There were no changes in depression or menopause-like symptoms in either group. CONCLUSION: Female adolescents with endometriosis initiating GnRHa therapy have impaired QOL. Treatment with GnRHa combined with add-back therapy led to improved QOL, with no worsening of mood or menopausal side effects. NA with CEE was superior to NA alone for improving physical health-related QOL. [Mh] Termos MeSH primário: Endometriose/tratamento farmacológico Hormônio Liberador de Gonadotropina/agonistas Leuprolida/administração & dosagem Noretindrona/análogos & derivados Qualidade de Vida [Mh] Termos MeSH secundário: Adolescente Boston Anticoncepcionais Orais Sintéticos/administração & dosagem Método Duplo-Cego Quimioterapia Combinada Endometriose/complicações Endometriose/psicologia Estrogênios/administração & dosagem Estrogênios Conjugados (USP)/administração & dosagem Feminino Seres Humanos Noretindrona/administração & dosagem Dor/etiologia Dor/psicologia Resultado do Tratamento Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Contraceptives, Oral, Synthetic); 0 (Estrogens); 0 (Estrogens, Conjugated (USP)); 33515-09-2 (Gonadotropin-Releasing Hormone); 9S44LIC7OJ (norethindrone acetate); EFY6W0M8TG (Leuprolide); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170607 [Lr] Data última revisão: 170607 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160302 [St] Status: MEDLINE

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[PMID]: 27788052 [Au] Autor: Behre HM; Zitzmann M; Anderson RA; Handelsman DJ; Lestari SW; McLachlan RI; Meriggiola MC; Misro MM; Noe G; Wu FC; Festin MP; Habib NA; Vogelsong KM; Callahan MM; Linton KA; Colvard DS [Ad] Endereço: Center for Reproductive Medicine and Andrology (H.M.B.), Martin Luther University, Halle-Wittenberg, D-06120 Halle, Germany; Center of Reproductive Medicine and Andrology (M.Z.), University of Münster, Münster, Germany; Medical Research Council Centre for Reproductive Health (R.A.A.), Queen's Medica [Ti] Título: Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men. [So] Source: J Clin Endocrinol Metab;101(12):4779-4788, 2016 Dec. [Is] ISSN: 1945-7197 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: CONTEXT: The development of a safe and effective reversible method of male contraception is still an unmet need. OBJECTIVE: Evaluation of suppression of spermatogenesis and contraceptive protection by coadministered im injections of progestogen and testosterone. DESIGN: Prospective multicentre study. SETTING: Ten study centers. PARTICIPANTS: Healthy men, aged 18-45 years, and their 18- to 38-year-old female partners, both without known fertility problems. INTERVENTION: Intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, administered every 8 weeks. MAIN OUTCOMES MEASURES: Suppression of spermatogenesis by ejaculate analysis, contraceptive protection by pregnancy rate. RESULTS: Of the 320 participants, 95.9 of 100 continuing users (95% confidence interval [CI], 92.8-97.9) suppressed to a sperm concentration less than or equal to 1 million/mL within 24 weeks (Kaplan-Meier method). During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59-4.14). The cumulative reversibility of suppression of spermatogenesis after 52 weeks of recovery was 94.8 per 100 continuing users (95% CI, 91.5-97.1). The most common adverse events were acne, injection site pain, increased libido, and mood disorders. Following the recommendation of an external safety review committee the recruitment and hormone injections were terminated early. CONCLUSIONS: The study regimen led to near-complete and reversible suppression of spermatogenesis. The contraceptive efficacy was relatively good compared with other reversible methods available for men. The frequencies of mild to moderate mood disorders were relatively high. [Mh] Termos MeSH primário: Androgênios/farmacologia Anticoncepção/métodos Anticoncepcionais/farmacologia Noretindrona/análogos & derivados Avaliação de Resultados (Cuidados de Saúde) Espermatogênese/efeitos dos fármacos Testosterona/análogos & derivados [Mh] Termos MeSH secundário: Adolescente Adulto Androgênios/administração & dosagem Androgênios/efeitos adversos Anticoncepção/efeitos adversos Anticoncepcionais/administração & dosagem Anticoncepcionais/efeitos adversos Quimioterapia Combinada Feminino Seres Humanos Injeções Intramusculares Masculino Noretindrona/administração & dosagem Noretindrona/efeitos adversos Noretindrona/farmacologia Gravidez Estudos Prospectivos Testosterona/administração & dosagem Testosterona/efeitos adversos Testosterona/farmacologia Adulto Jovem [Pt] Tipo de publicação: CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY [Nm] Nome de substância: 0 (Androgens); 0 (Contraceptive Agents); 3XMK78S47O (Testosterone); H16A5VCT9C (testosterone undecanoate); HY3S2K0J0F (norethindrone enanthate); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1707 [Cu] Atualização por classe: 170719 [Lr] Data última revisão: 170719 [Sb] Subgrupo de revista: AIM; IM [Da] Data de entrada para processamento: 161028 [St] Status: MEDLINE

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[PMID]: 27717552 [Au] Autor: Harada T; Momoeda M [Ad] Endereço: Department of Obstetrics and Gynecology, Tottori University School of Medicine, Tottori, Japan. Electronic address: tasuku@grape.med.tottori-u.ac.jp. [Ti] Título: Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. [So] Source: Fertil Steril;106(7):1807-1814, 2016 Dec. [Is] ISSN: 1556-5653 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: OBJECTIVE: To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. DESIGN: Placebo-controlled, double-blind, randomized trial. SETTING: Clinical trial sites. PATIENT(S): Two hundred fifteen subjects with dysmenorrhea. INTERVENTION(S): Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. MAIN OUTCOME MEASURE(S): Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. RESULT(S): The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. CONCLUSION(S): The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01129102. [Mh] Termos MeSH primário: Anticoncepcionais Orais Combinados/administração & dosagem Anticoncepcionais Orais Hormonais/administração & dosagem Dismenorreia/tratamento farmacológico Etinilestradiol/administração & dosagem Ciclo Menstrual/efeitos dos fármacos Noretindrona/administração & dosagem [Mh] Termos MeSH secundário: Administração Oral Adulto Analgésicos/uso terapêutico Anticoncepcionais Orais Combinados/efeitos adversos Anticoncepcionais Orais Hormonais/efeitos adversos Método Duplo-Cego Dismenorreia/diagnóstico Dismenorreia/fisiopatologia Etinilestradiol/efeitos adversos Feminino Seres Humanos Japão Noretindrona/efeitos adversos Medição da Dor Fatores de Tempo Resultado do Tratamento Avaliação da Capacidade de Trabalho Adulto Jovem [Pt] Tipo de publicação: COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Analgesics); 0 (Contraceptives, Oral, Combined); 0 (Contraceptives, Oral, Hormonal); 423D2T571U (Ethinyl Estradiol); T18F433X4S (Norethindrone) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170607 [Lr] Data última revisão: 170607 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161009 [Cl] Clinical Trial: ClinicalTrial [St] Status: MEDLINE

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[PMID]: 27535915 [Au] Autor: McGlinchey EM; James MH; Mahler SV; Pantazis C; Aston-Jones G [Ad] Endereço: Department of Neurosciences, Medical University of South Carolina, Charleston, South Carolina 29403, Brain Health Institute, Rutgers University and Rutgers Biomedical and Health Sciences, Piscataway, New Jersey 08854, and. [Ti] Título: Prelimbic to Accumbens Core Pathway Is Recruited in a Dopamine-Dependent Manner to Drive Cued Reinstatement of Cocaine Seeking. [So] Source: J Neurosci;36(33):8700-11, 2016 Aug 17. [Is] ISSN: 1529-2401 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: UNLABELLED: Glutamate inputs to nucleus accumbens (NAc) facilitate conditioned drug-seeking behavior and primarily originate from medial prefrontal cortex (mPFC), basolateral amygdala (BLA), and ventral subiculum of the hippocampus (vSub). These regions express Fos (a marker of neural activity) during cue-induced reinstatement of cocaine seeking, but only subpopulations of neurons within these regions drive drug seeking. One way to identify and functionally distinguish neural subpopulations activated during drug-seeking is to examine their projection targets. In rats, we examined Fos expression during cue-induced reinstatement of cocaine- and sucrose-seeking in prelimbic cortex (PL), infralimbic cortex (IL), BLA, and vSub neurons that project to NAc core (NAcC) or NAc shell (NAcSh). Neurons in PL, BLA, and vSub that project to NAcC, but not NAcSh, expressed Fos during cue-induced cocaine seeking, but not sucrose seeking. However, only activation of the PL-NAcC pathway positively correlated with cocaine reinstatement behavior, unlike BLA or vSub inputs to NAcC. To confirm a functional role for the PL-NAcC pathway, and to test the hypothesis that this pathway is recruited in a dopamine-dependent manner, we used a pharmacological disconnection approach whereby dopamine signaling was blocked in PL and glutamate signaling was blocked in the contralateral NAcC. This disconnection attenuated cue-induced reinstatement of cocaine seeking but had no effect on reinstatement of sucrose seeking. Our results highlight a role for the PL-NAcC pathway in cocaine seeking and show that these glutamatergic projections are recruited in a dopamine-dependent manner to drive reinstatement. SIGNIFICANCE STATEMENT: Relapse represents a significant barrier to the successful treatment of cocaine addiction. Here, we characterize the relative activation of glutamatergic inputs to nucleus accumbens during cued reinstatement of cocaine seeking versus sucrose seeking. Prelimbic cortex (PL) projections to nucleus accumbens core (NAcC) uniquely expressed Fos in a manner that positively correlated with cocaine-seeking, but not sucrose-seeking, behavior. Additional functional experiments showed that the PL-NAcC pathway was recruited by drug-associated cues in a dopamine-dependent manner to drive cocaine-seeking, but not sucrose-seeking, behavior. These data highlight PL neurons that project to NAcC, and their regulation by dopamine, as potential targets for therapeutics designed to treat cocaine relapse that do not affect natural reward seeking. [Mh] Termos MeSH primário: Cocaína/administração & dosagem Sinais (Psicologia) Dopamina/farmacologia Comportamento de Procura de Droga/efeitos dos fármacos Núcleo Accumbens/efeitos dos fármacos Córtex Pré-Frontal/efeitos dos fármacos [Mh] Termos MeSH secundário: Animais Toxina da Cólera/metabolismo Condicionamento Operante/efeitos dos fármacos Etinilestradiol Extinção Psicológica/efeitos dos fármacos Locomoção/efeitos dos fármacos Masculino Vias Neurais/efeitos dos fármacos Vias Neurais/fisiologia Neurotransmissores/farmacologia Noretindrona Proteínas Oncogênicas v-fos/metabolismo Ratos Ratos Sprague-Dawley Reforço (Psicologia) Autoadministração Sacarose/administração & dosagem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Neurotransmitter Agents); 0 (Oncogene Proteins v-fos); 37270-71-6 (norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination); 423D2T571U (Ethinyl Estradiol); 57-50-1 (Sucrose); 9012-63-9 (Cholera Toxin); I5Y540LHVR (Cocaine); T18F433X4S (Norethindrone); VTD58H1Z2X (Dopamine) [Em] Mês de entrada: 1707 [Cu] Atualização por classe: 170714 [Lr] Data última revisão: 170714 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160819 [St] Status: MEDLINE [do] DOI: 10.1523/JNEUROSCI.1291-15.2016

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