ISGE statement on oral emergency contraception.

Unintended pregnancy is an important public health problem worldwide. Unwanted pregnancies may end in induced abortion (legal or illegal, safe or unsafe) or in childbirth. In many parts of the world both can be life threatening. Even where both are safe, abortion is distressing for all concerned while unwanted births often lead to poor health and social outcomes for both the mother and her child.

A combined oral contraceptive containing drospirenone changes neither endothelial function nor hemodynamic parameters in healthy young women: a prospective clinical trial.

BACKGROUND: Combined oral contraceptives (COCs) may lead to a rise in cardiovascular disease risk, possibly associated with changes in blood pressure and endothelial function. STUDY DESIGN: The objective was to evaluate the impact of COC containing 20 mcg of ethinylestradiol (EE) and 3 mg of drospirenone (DRSP) on the arterial endothelial function, systolic and diastolic blood pressure (SBP and DBP , respectively), heart rate (HR), cardiac output (CO) and total peripheral resistance (TPR) of healthy young women. Of the 71 women in the study, 43 were evaluated before the introduction of COC and after 6 months of its use (case group) and 28, COC nonusers, were assessed for the same parameters at the same time interval (control group). RESULTS: No significant changes in endothelium-dependent and endothelium-independent functions or in measures of SBP, DBP, HR, CO and TPR caused by COC use were observed in the case group (p>.05 for all variables) or in the control group. CONCLUSION: These data suggest COC with 20 mcg EE and 3 mg DRSP does not alter arterial endothelial function or hemodynamic parameters in healthy young women.

HDL concentration, lipid transfer to HDL, and HDL size in normolipidemic nonobese menopausal women.

OBJECTIVE: To determine the impact of menopause on lipid transfer from donor lipoproteins to high-density lipoproteins (HDLs) -- a process that is related to the protective function of HDL -- and the size of HDL particles. METHOD: Plasma from 22 premenopausal and 18 postmenopausal nonobese, normolipidemic women paired for age (40-50 years) was incubated in an artificial nanoemulsion labeled with radioactive lipids. Then the HDL fraction was assessed for radioactivity; the percentage of radioactive lipids transferred from the nanoemulsion to HDL was determined; and the size of HDL particles was measured by laser light scattering. RESULTS: There were no differences between the 2 groups in serum concentration of HDL cholesterol (61+/-12 mg/dL vs 61+/-14 mg/dL) or apolipoprotein A(1) (1.5+/-0.3 g/L vs 1.5+/-0.2 g/L); lipid transfer to HDL; or size of HDL particles (8.8+/-0.8 vs 9.0+/-0.5 nm). CONCLUSION: Menopause was not found to affect HDL cholesterol plasma concentration, lipid transfer to HDL, or size of HDL particles in normolipidemic nonobese women.

A randomized study of low-dose conjugated estrogens on sexual function and quality of life in postmenopausal women.

OBJECTIVE: To evaluate the effects of combined vaginal and oral low-dose estrogen plus progestogen therapy (EPT) on the frequency and severity of dyspareunia, sexual function, and quality of life in recently postmenopausal women. METHODS: This outpatient, double-blind, randomized, placebo-controlled trial enrolled 285 healthy, sexually active postmenopausal women aged 45 to 65 years. Women received either one daily oral low-dose conjugated estrogens (0.45 mg)/medroxyprogesterone (1.5 mg) tablet for six 28-day cycles along with 1 g conjugated estrogens vaginal cream (0.625 mg), intravaginally for the first 6 weeks of the trial or a placebo cream and placebo tablet. Efficacy was evaluated using the McCoy Female Sexuality Questionnaire, self-reported daily diary cards, the Brief Index of Sexual Functioning-Women (BISF-W), and the Women's Health Questionnaire. RESULTS: The EPT group had a significant decrease in the frequency of dyspareunia compared with baseline and placebo in an analysis of responses to the McCoy Female Sexuality Questionnaire. Also, EPT was associated with a significant improvement in a woman's level of sexual interest, frequency of orgasm, and pleasure of orgasm. There was no effect of EPT use on coital frequency. The EPT group had significant improvement in receptivity/initiation and relationship satisfaction, although not in other BISF-W domains, versus placebo (BISF-W analysis) and significant improvement versus placebo on most Women's Health Questionnaire responses. CONCLUSIONS: EPT provided a statistically significant improvement compared with placebo in dyspareunia, sexual experience, and quality of life as measured in this study. In general, EPT also improved self-reported sexual perception and enjoyment significantly compared with placebo.

Effects of estradiol and norethisterone on lipids, insulin resistance and carotid flow.

OBJECTIVES: To evaluate the lipid profile, insulin resistance and vasomotricity, and the interaction between these factors, in postmenopausal women receiving hormone therapy. METHODS: A prospective, randomized, double-blind study was carried out in which 77 postmenopausal women received one of the three treatment regimens: (A) 2mg oral micronized estradiol (E2) (n=25); (B) 2mg oral E2+1mg oral norethisterone acetate (NETA) (n=28); or C) placebo (n=24), daily for 6 months. Evaluations were carried out at baseline and at the end of treatment on lipid and lipoprotein profiles, homeostasis model assessment of insulin resistance (HOMA-IR) and pulsatility index (PI) of the internal carotid artery by Doppler ultrasonography. RESULTS: Mean increases of 15.6% and 2.4% and a reduction of 6.4% in high-density lipoprotein (HDL) levels were found for the E2, E2+NETA and placebo groups, respectively. Reductions of 9.5% and 3.7% and an increase of 12.1% in low-density lipoprotein (LDL), and reductions of 20.0% and 3.8% and an increase of 28.8% in the LDL:HDL ratio were found for the E2, E2+NETA and placebo groups, respectively (p<0.001 in all cases). Insulin levels and HOMA-IR decreased 12.8% and 12.3% in the E2 group and increased 12.9% and 16.0% in the E2+NETA group (p<0.05), respectively. Carotid PI following treatment was 1.18+/-0.23, 1.38+/-0.20 and 1.41+/-0.21 for the E2, E2+NETA and placebo groups, respectively (p=0.0006). CONCLUSIONS: Oral estrogen therapy led to an improvement in lipid profile, insulin resistance and carotid blood flow, which was cancelled when NETA was associated.

Latin American position on the current status of hormone therapy during the menopausal transition and thereafter.

OBJECTIVE: Data from placebo-controlled, randomized clinical trials conducted during the past few years resulted in critical re-evaluation of the overall health benefits of hormone therapy (HT) in women during the menopausal transition and thereafter. These data stimulated vigorous debate among experts and produced several position papers by North American and European authorities providing guidance on the use of HT. It is well known that cultural, geographic and ethnic differences influence the acceptance and risk perception of HT. Therefore, it was considered essential to present a position specifically relevant to Latin American countries. METHODS: A Latin American Expert Panel, convening in Salvador, Bahia, Brazil, obtained consensus on recommendations for HT that incorporated the findings of the most recently published reports. The panelists' opinions were surveyed by means of the Likert scale along five categories ranging from complete agreement to complete disagreement. RESULTS: The Panel presented 13 recommendations and considered three additional issues relevant to HT use. There was consensus that HT during the perimenopause and thereafter is warranted in Latin American women in particular for the management of vasomotor symptoms. HT may also be an option for osteoporosis prevention in women at significant risk, after evaluation of risks/benefits and after consideration of alternative therapies. HT should be individualized and prescribed at the lowest effective dose. CONCLUSIONS: The Panel concluded that HT remains a safe and effective treatment option for peri- and postmenopausal Latin American women.

Morphometric evaluation of effects of two sex steroids on mammary gland of female rats.

OBJECTIVE: The purpose of this study was to evaluate the effects of two sex hormones on normal mammary gland of female rats. METHODS: Forty 250-day-old female rats, 20 of them with offspring and 20 not, were ovariectomized and, divided into 4 subgroups in order to receive one of the following subcutaneous treatment: estradiol benzoate (EB), medroxyprogesterone (MPA), EB+MPA or placebo, for 10 weeks. After treatment, mammary glands were studied with optical microscope. Whole gland, lobule, ductule and lumen compartments were evaluated by morphometric methods. Also a qualitative evaluation were performed seeking for secretion, microcalcification and trophic status. RESULTS: It was found that (a) MPA-only and placebo were similar for all parameters; (b) the same between EB and EB+MPA; (c) EB and EB+MPA increased lobule, ductule and lumen compartments significantly compared to MPA-only or placebo; (d) EB increased epithelium but without significance and EB+MPA increased it significantly compared to placebo or MPA; (e) EB and EB+MPA incremented secretion. CONCLUSIONS: In normal mammary gland of female rats: progestin action depends on estrogen presence. MPA does not revert estrogen-dependent proliferation, but it magnifies estradiol effect. Both EB and EB+MPA stimulate differentiation. Rats without offspring presented a greater epithelial proliferation under treatment with these sex hormones.

Effects in post-menopausal women of transdermal estrogen associated with progestin upon the removal from the plasma of a microemulsion that resembles low-density lipoprotein (LDL).

OBJECTIVE: To evaluate the effects of transdermal estradiol and medroxyprogesterone acetate (MPA) treatment on the removal from the plasma of a cholesterol-rich microemulsion (LDE) that roughly resembles low-density lipoprotein (LDL) structure and that binds to LDL receptors. METHODS: Ten healthy post-menopausal women were studied before and after 3-month treatment with transdermal estradiol in the following dosages administered every 3.5 days: 25, 50, 50, 100, 100, 50, 50 and 25 microg. From the 15th to the 21st day and from the 22nd to the 28th day of estrogen treatment, respectively, 10 and 5 mg q.d. MPA per oral were associated to the transdermal estrogen. The emulsion labeled with 14C-cholesteryl oleate was injected after 12 h fasting and its fractional catabolic rate (FCR) was calculated from the plasma decaying curves of the isotope. RESULTS: Treatment reduced LDL-cholesterol levels by 8% only (149.0 +/- 36.0 mg/dl, 138.0 +/- 27.0 mg/dl; P = 0.046), but the FCR of LDE expressed in medians (25%; 75%) increased from 0.0054 (0.003; 0.052) h(-1) to 0.021 (0.009; 0.10) h(-1), P = 0.002. CONCLUSION: The association used in this study so as to mimic the increasing-decreasing pattern of the hormonal ovarian production reduced modestly LDL-cholesterol levels but pronouncedly increased the lipoprotein removal as tested by LDE FCR.

Impact of subserosal and intramural uterine fibroids that do not distort the endometrial cavity on the outcome of in vitro fertilization-intracytoplasmic sperm injection.

OBJECTIVE: To further evaluate the effects of intramural and subserosal uterine fibroids on the outcome of IVF-ET, when there is no compression of the endometrial cavity. DESIGN: Retrospective, matched-control study from January 2000 to October 2001. SETTING: Private IVF center. PATIENT(S): Two hundred forty-five women with subserosal and/or intramural fibroids that did not compress the uterine cavity (fibroid group) and 245 women with no evidence of fibroids anywhere in the uterus (control group). INTERVENTION(S): In vitro fertilization-intracytoplasmic sperm injection (IVF-ICSI) cycles. MAIN OUTCOME MEASURE(S): The type of fibroid (intramural, subserosal), number, size (cm), and location of intramural leiomyomas (fundal, corpus) were recorded. Outcomes of IVF-ICSI cycles were compared between the two groups. RESULT(S): There was no correlation between location and number of uterine fibroids and the outcomes of IVF-ICSI. Patients with subserosal or intramural fibroids <4 cm had IVF-ICSI outcomes (pregnancy, implantation, and abortion rates) similar to those of controls. Patients with intramural fibroids >4.0 cm had lower pregnancy rates than patients with intramural fibroids 4 cm and that such patients be submitted to treatment before they are enrolled in IVF-ICSI cycles. Whether or not women with fibroids > 4 cm would benefit from fibroid treatment remains to be determined.

Composiçäo corpórea, distribuiçäo de gordura e metabolismo de repouso em mulheres histerectomizadas no climatério: há diferenças de acordo com a forma da administraçäo do estrogênio? / Body composition, fat distribution and rest metabolism in hysterectomized women in climacteric: is there any difference to agree with the estrogen administration form?

As mulheres no climatério sofrem inúmeras alterações metabólicas, cardiovasculares e de composição corporal. A terapêutica de reposição hormonal (TRH) vem alcançando importância na atualidade, tornando-se quase um consenso que a mulher após a menopausa deve receber hormônios, pelos benefícios que trazem para a saúde, tais como prevenção de doenças coronarianas e osteoporose. A forma de administração de estrogênios influi em uma série de parâmetros metabólicos; é sabido, por exemplo, que a administração oral provoca uma elevação no hormônio de crescimento (GH) e uma diminuição do IGFI: quanto à forma (transdérmica), os estudos ainda não são conclusivos quanto aos níveis do GH e IGFI. Por outro lado, o GH e o IGFI podem agir de maneiras diferentes no metabolismo lipídico, ósseo e na distribuição de gordura corpórea. O objetivo deste trabalho foi estudar as variações da distribuição visceral de gordura nas diferentes formas de administração estrogênica e, particularmente, verificar se a forma de administração do hormônio altera a quantidade de gordura visceral. Foram estudadas 33 mulheres no climatério, histerectomizadas, divididas em 3 grupos: 1) 13 pacientes recebendo estrogênio eqüino conjugado 0,625mg via oral diariamente; 2) 10 pacientes recebendo 17b estradiol TTS 50 2x/semana via transdérmica e; 3) 10 pacientes recebendo placebo. Estas pacientes foram submetidas: a) análise da composição corporal pelos métodos de bioimpedância (RJL 101-A) e densitometria óssea e corpórea (DEXA); b) análise da distribuição de gordura, particularmente de adiposidade visceral, pela tomografia computadorizada abdominal e; c) medida do metabolismo de repouso pelo calorímetro DELTA-TRAC. Foram ainda feitas dosagens laboratoriais de colesterol total e frações, triglicérides e glicemia aos 0, 6 e 12 meses. Não observamos diferenças estatística significativas nos parâmetros estudados em nenhum dos 3 grupos (placebo, estrógeno oral e estrogênio transdérmico), embora notamos tendência a maior ganho de peso nos grupos com estrógenos e tendência a maior ganho de massa magra no grupo com estrogênio transdérmico.

Avaliação da tolerabilidade e do controle de ciclo de dois contraceptivos orais de baixa dose: estudo comparativo aberto / Assessment of the tolerability and cycle control of two low-dose oral contraceptives: an open-label study

Realizou-se um estudo aberto comparativo em nove centros brasileiros para avaliar a tolerabilidade e o controle de ciclo obtido com o uso de dois contraceptivos orais de baixa dose contendo 20 mg etinilestradiol/75 mg gestodeno e 20 mg etinilestradiol/150 mg desogestrel, durante seis ciclos de tratamento. Foram selecionadas 167 mulheres saudáveis com vida sexual ativa (77 no grupo do gestodeno e 90 no grupo do desogestrel), das quais 138 completaram os seis ciclos de tratamento. Em um subgrupo de novas usuárias realizou-se também perfil lipídico e hemostático. Foram avaliados 867 diclos no total. Ocorreu sangramento irregular em 4,6 por cento dos ciclos com gestodeno e em 8,1 por cento com desogestrel. A tolerabilidade a ambas preparações foi boa, mas houve significativamente mais náusea no grupo do desogestrel. O controle de ciclo foi bom com os dois contraceptivos, sendo que houve freqüência significativamente menor de sangramento irregular no grupo do gestodeno quando se leva em conta que todos os ciclos foram considerados. Não houve alterações clinicamente significativas no perfil hemostático. O perfil lipídico mostrou tendência a tornar-se mais favorável após seis ciclos de tratamento com as duas preparações. Não ocorreu alteração no peso médio das mulheres no grupo do gestodeno; no grupo do desogestrel houve aumento significativo no peso médio de aproximadamente 1 Kg após seis meses de tratamento. A adesão ao tratamento foi boa com as duas preparações. Os resultados deste estudo mostram que preparações contendo baixa dose de gestodeno ou desogestrel associados a 20 mg de etinilestradiol são contraceptivos bem tolerados que permitem bom controle de ciclo, sem efeitos colaterais significantes.