Clinical observation of combined oral contraceptives drospirenone and ethinylestradiol tablets (Ⅱ) in the treatment of dysmenorrhea in Chinese women / 中华妇产科杂志

Objective:To evaluate the efficacy and safety of drospirenone and ethinylestradiol tablets (Ⅱ) in Chinese women with dysmenorrhea.Methods:This was a single-arm, open-label, interventional, multicenter, post-authorization safety/effectiveness study of drospirenone and ethinylestradiol tablets (Ⅱ) across 6 treatment cycles, a total of 526 patients were included in the dysmenorrhea subgroup. Visual analog scale (VAS) was used to assess the severity of menstrual pain. Secondary outcomes included unintended pregnancies, bleeding pattern, cycle control and safety.Results:After treated with drospirenone and ethinylestradiol tablets (Ⅱ), VAS of pain had decreased significantly compared with baselines [(49.5±23.7) vs (32.3±24.9) vs (20.7±19.4) vs (18.4±18.7) mm, P<0.01]. From the second cycle to the fifth cycle, the incidence of scheduled bleeding increased from 93.9% (450/479) to 96.4% (431/447). The duration of scheduled bleeding decreased from (5.7±2.7) to (5.4±1.8) days. The incidence of intermenstrual bleeding decreased from 9.0% (43/479) to 5.6% (25/447). 17.5% (92/526) patients reported adverse drug reactions, most frequently reported adverse events were breast pain, nausea, breast swelling, headache, and uterine bleeding. No death occurred during the study. Conclusion:Drospirenone and ethinylestradiol tablets (Ⅱ) is effective for the treatment of dysmenorrhea and has good safety.

Efectos de la terapia hormonal con drospirenona / 17 ß - estradiol sobre los parámetros del síndrome metabólico en posmenopáusicas / Effects of hormone therapy with drospirenone / 17 ß - estradiol on the parameters of the metabolic syndrome in postmenopausal women

Evaluar los efectos de la terapia hormonal (TH) con Drospírenona (DRSP)/17 ß -estradiol (E2), sobre los parámetros del Síndrome Metabólico (SM) en pacientes postmenopáusicas. Métodos: Investigación comparativa y aplicada, con diseño cuasi experimental, de casos y controles a simple ciego, prospectivo y de campo; realizada en la Consulta de Ginecología. Hospital "Dr. Manuel Noriega Trigo". San Francisco, Estado Zulia. Venezuela. Participaron 120 mujeres separadas al azar para recibir la combinación DRSP/E2 (Grupo A) o un placebo (Grupo B). Se evaluaron los componentes del SM antes y posterior a 6 meses de haber recibido la TH. Resultados: Se encontró una alta prevalencia de SM en ambos grupos antes de recibir el tratamiento (53,3% y 48%; grupo A y B respectivamente). Posterior al tratamiento, DRSP/E2 al compararse con un placebo, redujo significativamente tanto la prevalencia del SM como el riesgo de padecerlo (21,7% versus 48,3%, OR [IC95%]= 0,29 [0,13-0,65]; p < 0.001), con reducción significativa (p< 0.001) de la hipertensión arterial, glicemia basal alterada, hipertrigliceridemia y obesidad central; además de una reducción significativa de los síntomas vasomotores, síntomas psicológicos e incontinencia urinaria (p< 0.001). En el grupo B la prevalencia del SM se mantuvo sin cambios, salvo para la glicemia basal alterada y los síntomas vasomotores y psicológicos que mostraron una reducción significativa (p< 0.001). Conclusión: DRSP/E2 (2mg/1 mg) demostró ser eficaz luego de 6 meses de tratamiento tanto para el control de los parámetros que definen al SM; con pocos y leves efectos indeseados(AU)

To assess the effects of hormone therapy (HT) with drospirenone (DRSP)/17 ß -estradiol (E2) on the parameters of the metabolic syndrome (MS) in postmenopausal patients. Methods: We performed a comparative and applied research, with quasiexperimental, case-control, single-blind, prospective and field design. The study was realized in the Gynecology consultation. Hospital "Dr. Manuel Noriega Trigo". San Francisco, Estado Zulia. Venezuela. 120 women were included, they were separated to receive either the combination DRSP/E2 (Group A) or placebo (Group B). We assess MS components before and ather 6 months of receiving HT. Results: We found a high prevalence in both groups before receiving treatment (53.3% and 48%, group A and B respectively). A ther treatment, DRSP/E2 when compared to placebo, significantly reduced both the prevalence of MS as the risk of setting it (21.7% versus 48.3%, OR [95%] = 0.29 [0.13-0.65] p <0.001), with a significant reduction (p <0.001) of hypertension, impaired fasting glucose, hypertriglyceridemia, central obesity; and a significant reduction in vasomotor symptoms, psychological symptoms and urinary incontinence (p <0.001). In group B the prevalence of MS was unchanged, except for impaired fasting glycemia and vasomotor and psychological symptoms showed a significant reduction (p <0.001). Conclusion: DRSP/E2 (2mg /1mg), proved to be effective a ther 6 months of treatment both for the control of the parameters that define the SM, with few and mild side effects(AU)

The influence of hormone therapy with drospirenone-estradiol on endometrioid type endometrial cancer patients / 부인종양

OBJECTIVE: To determine whether drospirenone/estradiol (DRSP/E2) has an adverse effect on clinical outcomes in surgically staged International Federation of Gynecology and Obstetrics (FIGO) stage I/II endometrial cancer (EC) patients. METHODS: In a retrospective case-controlled study, 58 women with EC who had received DRSP/E2 postoperatively were compared with 116 women who had not. And, oncologic safety of postoperative hormone therapy with DRSP/E2 in EC survivors were compared between the 2 groups after propensity score matching using a logistic regression model. RESULTS: The median ages were 47.7 years and 53.6 years for the study and the control groups, respectively (p < 0.001). The study group had similar parity (p = 0.71), lower body mass index (p = 0.03) and more premenopausal women (p < 0.001) than the control group. The stages were completely matched. The grades (p = 0.42), lymphovascular space invasion (p = 0.23), preoperative cancer antigen 125 (CA 125) level (p = 0.89), and hormone receptor status (p = 0.07) were similar in both groups. The median tumor diameter was statistically larger in the study group than in the control group (p < 0.001). Both group received similar adjuvant therapy (p = 0.80). In the propensity matching, only hormone receptor status was significantly different (p = 0.03). In the univariate analysis, only stage was significantly associated with disease-free survival (DFS) and there was no variable associated with overall survival (OS). And, there was no significant factor identified in multivariate analysis. The difference in the DFS (p = 0.63) and in the OS (p = 0.32) was not significant. The same results were obtained after propensity score matching. CONCLUSION: Postoperative hormone therapy with DRSP/E2 in EC survivors did not increase recurrence or the death rate.

Cálculo del Índice de Pearl de etinilestradiol 30 mcg/drospirenona 3 mg (Genesa®)

Objetivo: Calcular el índice de Pearl de Genesa® en mujeres venezolanas. Métodos: Estudio fase IV, prospectivo y abierto. Las pacientes recibieron etinilestradiol 30 mcg / drospirenona 3 mg (Genesa®): un comprimido diario desde el primer día de la menstruación por 21 días; descanso de siete días y reinicio el día ocho. Resultados: Se ingresaron al estudio 115 pacientes, se obtuvo un índice de Pearl de 0,98. Los efectos adversos fueron: un embarazo, incremento de peso, retención de líquidos, náuseas, manchas en la piel. Conclusiones: Etinilestradiol 30 mcg/drospirenona 3 mg (Genesa®) presenta un adecuado índice de Pearl en mujeres venezolanas.

Objective: To calculate the Pearl index of Genesa® in Venezuelan women. Methods: Phase IV prospective and open study. Patients received ethinylestradiol 30 mcg / drospirenone 3 mg (Genesa®): one tablet daily from the first day of menstruation for 21 days; seven-day break and restart the eighth day. Results: 115 patients were admitted to the study, a Pearl index of 0.98 was obtained. Most common side effects: one pregnancy, weight gain, fluid retention, nausea, skin blemishes. One patient discontinued treatment for adverse effects (vomiting and nausea). Conclusions: Genesa® presents an adequate Pearl Index in Venezuelan woman.

Clinical prevent effect of taking drospirenone and ethinylestradiol tablets on intrauterine adhesion after missed abortion curettage with b-ultrasonic observation / 中国生化药物杂志

Objective To discuss clinical efficacy of taking drospirenone and ethinylestradiol tablets in preventing intrauterine adhesion after missed abortion curettage with b-ultrasonic observation.Methods216 cases of study objects provided with missed abortion curettage with b-ultrasonic observation were divided into control group with 108 cases and research group with 108 cases.Patients in control group were provided with conventional treatment after surgery, while those in research group were provided with conventional treatment and drospirenone and ethinylestradiol tablets.Two groups were compared for condition after surgery such as intrauterine adhesion in 1month after treatment, secondary pregnancy, infertility and abortion in 1 year after treatment.ResultsTime of vaginal bleeding, pelvic effusion and time of return of menses in research group were significantly lower than those in control group, with difference having statistical significance (t=6.114,t=9.481,t=9.201,P0.05).In the case of infertility rate and rate of abortion in 1 year after treatment, control group was higher than research group with difference having statistical significance (χ2=4.317,χ2=5.225,P<0.05).ConclusionTaking drospirenone and ethinylestradiol tablets after missed abortion curettage with b-ultrasonic observation can effectively prevent intrauterine adhesion, which can also reduce complications such as abortion and infertility, therefore, it shall be applied in accordance with specific condition of patients.

Effects of Compound Leonurus artemisia Ointment Combined with Drospirenone and Ethinylestradiol Tablets on Serum Progesterone and Th1/Th2 Cytokine after Medical Abortion / 中国药房

OBJECTIVE:To investigate the effects of Compound Leonurus artemisia ointment combined with Drospirenone and ethinylestradiol tablets on serum progesterone and T helper (Th) 1/Th2 cytokine after medical abortion.METHODS:A total of 228 patients underwent medical abortion selected from obstetrical outpatient of our hospital during our hospital during Mar.2013 to Jul.2015 as research object were divided into control group (109 cases) and observation group (119 cases) according to random number table.Control group was given Cefuroxime axetil tablets 0.25 g,po,bid,for consecutive 6 d for anti-infective treatment+ Drospirenone and ethinylestradiol tablets one tablet,po,qd,21 d as a treatment course,8 d later receiving second course,3 courses in total after fetal sac exclusion.Observation group was additionally given Compound L.artemisia ointment 10 g,po,bid,7 d as a treatment course,2 courses in total on the basis of control group.The levels of serum progesterone and Th1 (TNF-α,IFN-γ,IL-2)/Th2 cytokine (IL-4,IL-6,IL-10) were observed in 2 groups,and the occurrence of ADR was recorded.RESULTS:Before treatment,there was no statistical significance in serum progesterone or Th1/Th2 cytokine levels between 2 groups (P＞0.05).After treatment,serum progesterone,TNF-α,IL-2 and IL-6 levels of 2 groups were decreased significantly,and above indexes of observation group were significantly lower than those of control group.The levels of IL-4 and IL-10 in 2 groups were increased significantly,and above indexes of observation group were significantly higher than control group,with statistical significance (P＜0.05).After treatment,IFN-γ levels of 2 groups were decreased significantly,but there was no statistical significance between 2 groups (P＞0.05).No obvious ADR was found in 2 groups during treatment.CONCLUSIONS:Compound L.artemisia ointment combined with Drospirenone and ethinylestradiol tablets can regulate immune function of patients after medical abortion,and promote dynamic balance of Th1/Th2 cytokines with good safety.

Efficacy and safety of drospirenone 2 mg/17β-estradiol 1 mg hormone therapy in Korean postmenopausal women

This regulatory post-marketing surveillance study aimed to evaluate the therapeutic efficacy and safety of drospirenone (DRSP) 2 mg/estradiol (E₂) 1 mg tablet in Korean postmenopausal women. A total of 4,149 patients were enrolled and the study was conducted at 207 clinical research centers. The patients' source data was collected between November 2006 and November 2012. More than 85% of patients experienced improvement of menopausal symptoms. The most frequently reported adverse events were vaginal bleeding and breast pain; most of the women suffering from these symptoms fully recovered. The incidence of adverse event was higher in patients of younger age (20 to 39 years), in patients with concomitant diseases, previous hormone replacement therapy in medical history, those treated with DRSP 2 mg/E₂ 1 mg for shorter duration (3 years or less) and in patients using concomitant medication. In conclusion, the results from this large post-marketing surveillance study confirm the efficacy and safety of DRSP 2 mg/E₂ 1 mg tablet in Korean postmenopausal women.

Clinical observation of Drospirenone and Ethinylestradiol Tablets for preventing postoperative complications of induced abortion / 中国生化药物杂志

Objective To observe the clinical effect of postoperative complications in patients with induced abortion by taking Drospirenone and Ethinylestradiol Tablets.Methods 400 patients with induced abortion from November 2015 to May 2016 were randomly divided into the observation group and the control group,200 cases in each group.The control group was treated with routine antibiotic therapy.The observation group treatment with Drospirenone and Ethinylestradiol Tablets based on the control group, 1 per one night, 21d for a course of treatment, continuous use of 6 courses.Compared the 2 groups of patients with postoperative complications of pelvic infection,intrauterine adhesions,pregnancy,recurrent abdominal pain and two groups of postoperative recovery time of menstruation,vaginal bleeding,endometrial thickness.Results In the observation group after pelvic infection,uterine cavity adhesion,pregnancy,periodic abdominal pain incidence were 1.5%,0.5%,0.0%,1.5%,were significantly lower than that of the control group7.0%,3.5%,4.0%,5.5%(P<0.05);the observation group after menstruation recovery time,vaginal bleeding,endometrial thickness respectively(27.2 ±1.7) d,(6.2 ±1.4)d,(7.2 ±2.3) mm,were lower than the control group(32.5 ±6.0) d,(7.8 ±2.7) d,(5.0 ±2.4) mm,two groups of the difference was statistically significant(P<0.05).Conclusion After artificial abortion,taking Drospirenone and Ethinylestradiol Tablets can effectively reduce the incidence of complications,improve the quality of life of patients,the method is simple,safe,effective and good compliance.

Clinical Observation of Hysteroscopy Combined with Drospirenone Ethinylestradiol in the Treatment of Endometrial Polyps / 沈阳医学院学报

Objective:To explore the clinical efficacy of hysteroscopy combined with drospirenone ethinylestradiol in the treatment of endometrial polyps. Methods:A total of patients with endometrial polyps from Feb 2014 to Dec 2015 were randomly divided into 2 groups.The control group was given hysteroscopic surgery. Intravenous infusion of oxytocin and antibiotics after operation was done. The observation group on the basis of the control group received oral administration of drospirenone and ethinylestradiol tablets (1 tablet/d), taking 3 consecutive weeks, and a total of 3 cycles. In the postoperative 4 months follow-up, the curative effect and complications was compared. Results: There was significant difference in menstrual improvement rate in 2 groups (P<0.05) . The recurrence rate in the control group was significantly higher than that in the observation group (P<0.05), but there was no difference in the pregnancy within 6 months after the surgery and adverse reactions (P>0.05) . Conclusion:The endometrial polyps performed hysteroscopic surgery combined with drospirenone ethinyl estradiol can effectively improve menstrual bleeding and cycle,reduce the recurrence of endometrial polyp,and the adverse reaction.

Hormonal therapy with estradiol and drospirenone improves endothelium-dependent vasodilation in the coronary bed of ovariectomized spontaneously hypertensive rats

Drospirenone (DRSP) is a progestin with anti-aldosterone properties and it reduces blood pressure in hypertensive women. However, the effects of DRSP on endothelium-dependent coronary vasodilation have not been evaluated. This study investigated the effects of combined therapy with estrogen (E2) and DRSP on endothelium-dependent vasodilation of the coronary bed of ovariectomized (OVX) spontaneously hypertensive rats. Female spontaneously hypertensive rats (n=87) at 12 weeks of age were randomly divided into sham operated (Sham), OVX, OVX treated with E2 (E2), and OVX treated with E2 and DRSP (E2+DRSP) groups. Hemodynamic parameters were directly evaluated by catheter insertion into the femoral artery. Endothelium-dependent vasodilation in response to bradykinin in the coronary arterial bed was assessed using isolated hearts according to a modified Langendorff method. Coronary protein expression of endothelial nitric oxide synthase and estrogen receptor alpha (ER-α) was assessed by Western blotting. Histological slices of coronary arteries were stained with hematoxylin and eosin, and morphometric parameters were analyzed. Oxidative stress was assessed in situ by dihydroethidium fluorescence. Ovariectomy increased systolic blood pressure, which was only prevented by E2+DRSP treatment. Estrogen deficiency caused endothelial dysfunction, which was prevented by both treatments. However, the vasodilator response in the E2+DRSP group was significantly higher at the three highest concentrations compared with the OVX group. Reduced ER-α expression in OVX rats was restored by both treatments. Morphometric parameters and oxidative stress were augmented by OVX and reduced by E2 and E2+DRSP treatments. Hormonal therapy with E2 and DRSP may be an important therapeutic option in the prevention of coronary heart disease in hypertensive post-menopausal women.

The clinical observation of estradiol valerate and drospirenone applying in missed abortion and curettage before and after operation / 中国基层医药

Objective To observe the clinical effects of estradiol valerate and drospirenone applying in missed abortion and curettage before and after operation.Methods 160 patients with missed abortion parallel curet-tage were chosen,who were randomly divided into the observation group and control group by the number table meth-od.Two groups of patients were oral misoprostol 400 g before uterine curettage 1 h,and then were treated with ultra-sonic curettage after filling the bladder and postoperative routine use of antibiotics for 3 D.3 D before the curettage, observation group were treated with oral estradiol valerate 4 mg for 3 D,2times a day..After curettage of the day, drospirenone orally was given for 1 tablet every night,used in conjunction a cycle for 3weeks.The control group before and after curettage were given without estradiol valerate and drospirenone.Operation time,bleeding volume,postopera-tive bleeding time and bleeding volume,the time of the first menstrual cycle,endometrial repair and postoperative complications were observed in the two groups.Results In the control group,operation time,intraoperative bleeding volume,for the first time the resumption of menstruation tide time,endometrial thickness,postoperative complication rate were (6.05 ±0.49)min,(50.88 ±9.18)mL,(36.51 ±1.95)d,(4.08 ±0.56)mm and 15.0%;the data of the observation group were (4.46 ±0.45)min,(35.63 ±8.24)mL,of (29.28 ±1.57)d,(6.11 ±0.76)mm and 3.8%.The operation time,intraoperative bleeding volume,for the first time the resumption of menstruation tide time, endometrial thickness,postoperative complication rate differences of the two groups were statistically significant(t =-11.264,-16.643,-24.93,19.151,χ2 =5.959,all P <0.05).Conclusion Giving estradiol valerate and flexor buspirone before and after missed abortion and curettage,can effectively improve the short -term and long -term complications of uterine curettage,and improve the clinical efficacy of dilatation and curettage.

Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 μg in the treatment of premenstrual dysphoric disorder：a randomized, double blind placebo-controlled study / 中华妇产科杂志

Objective To compare the efficacy and safety of a new low-dose oral contraceptive pill (YAZ) containing drospirenone 3 mg and ethinylestradiol 20 μg with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD). Methods This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles (84 days) with daily symptom charting; 187 women with symptoms of PMDD were randomized to either placebo group (n=94) or YAZ group (n=93), and assessed with daily record of severity of problems scale (DRSP) and clinical global impressions scale (CGI) before, during and after the treatments. Hormones were administered for 24 days, followed by 4 days of inactive pills. Results Compared with baseline level of DRSP, both groups got improvement after treatment; the YAZ group (median-28.7, range:-82.5 to 2.3) had greater improvement than that in the placebo group (median-23.7, range:-86.0 to 11.8), while there was not significant difference (P>0.05). The main adverse effects of YAZ included intermenstrual bleeding [13% (12/93) versus 3% (3/94)], menorrhagia [9% (8/93) versus 1%(1/94)], nausea [5%(5/93) versus 4%(4/94)] and skin rash [4%(4/93) versus 2%(2/94)]. Conclusions YAZ could improve symptoms of PMDD better than placebo, while without statistic significance in this study. The most common adverse effects are intermenstrual bleeding, menorrhagia, nausea and rash.

Systematic evaluation of estradiol drospirenone treatment on palpitation in postmenopausal women / 中国医师进修杂志

Objective To evaluate the efficacy of estradiol drospirenone treatment on palpitation in postmenopausal women.Methods Retrieved nearly a decade PubMed,Science Direct,EBSCO Host,EMbase,The Cochrane Library,CNKI,Wanfang database,CQVIP.The evaluation methodology included.The researchers rigorously evaluated he quality of the included studies and extracted data,used the Review manager 5.0 software to meet the quality standards of randomized controlled clinical trials (RCT) line system evaluation.Results Thirteen RCTs were included 1 156 patients,506 cases in the control group,650 patients in the treatment group.The results of the evaluation of the system showed:estradiol drospirenone treatment could significantly improve the efficacy of postmenopausal symptoms,compared with hormone therapy [relative risk (RR) =-11.89,95％ confidence interval (95 ％ CI)-13.06--10.72],versus placebo therapy (RR =-12.99,95％CI-14.46--11.52).Conclusion Estradiol drospirenone can significantly enhance the efficacy of postmenopausal symptoms,be worthy of promotion.

Efecto de la terapia hormonal combinada (drospirenona / 17 β -estradiol) sobre el peso corporal en posmenopáusicas

Objetivo: Comparar los efectos de la terapia hormonal combinada (drospirenona /17 β-estradiol) versus un placebo sobre el peso corporal u otras variables antropométricas en pacientes posmenopáusicas asistidas en la consulta ginecológica del Hospital “Dr. Manuel Noriega Trigo”, Estado Zulia, Venezuela. Métodos: Estudio cuasi-experimental, de casos y controles, aleatorio, a simple ciego, en el cual participaron 120 mujeres posmenopáusicas, divididas en dos grupos para recibir una dosis diaria durante 6 meses de una terapia hormonal combinada (grupo A; drospirenona 2 mg/ 17 β-estradiol 1 mg) o un placebo (grupo B). Se evaluaron tanto el peso corporal como el índice de masa corporal, circunferencia abdominal e índice de cintura cadera, antes y al final del tratamiento. Resultados: Se evidenció que en el grupo que recibió la terapia hormonal hubo una reducción de alrededor de 3 kg en la media del peso corporal luego de 6 meses de tratamiento (79,80±9,35 vs. 76,33±8,36; P< 0,001); asimismo, una reducción significativa en el índice de masa corporal (30,12±2,02 vs. 28,72±1,79; P< 0,001), circunferencia abdominal (120,10±14,73 vs. 110,10±14,00; P< 0,001) y en el índice cintura cadera (0,87±0,04 vs. 0,84±0,07; P< 0,05). En el grupo que recibió un placebo no hubo modificaciones significativas en estas variables. Conclusiones: La terapia hormonal con drospirenona /17 β-estradiol se asoció con una reducción significativa del peso corporal, índice de masa corporal, circunferencia abdominal e índice cintura cadera luego de 6 meses de tratamiento en posmenopáusicas; con pocos o leves efectos adversos.

Objective: To compare the effects of combined hormonal therapy (drospirenone/17 β-estradiol) versus a placebo on body weight and other anthropometric variables in postmenopausal women assisted in the gynecology consultation at the Hospital “Dr. Manuel Noriega Trigo”, in Zulia state, Venezuela. Methods: A quasi-experimental, case control, randomized, single blind study, which involved 120 postmenopausal women, divided into two groups to receive a daily dose for 6 months of combined hormone therapy (group A; drospirenone 2 mg/ 17 β-estradiol) or placebo (group B). We evaluated body weight, body mass index, waist circumference and waist-hip ratio, before and at the end of treatment. Results: We showed that in the group receiving hormonal therapy with drospirenone / 17 β-estradiol was a reduction of about 3 kg in mean body weight after 6 months of treatment (79,80 ± 9,35 vs. 76,33 ± 8,36; P <0,001); and a significant reduction in body mass index (30,12 ± 02,02 vs. 28,72 ± 1,79; P <0,001), abdominal circumference (120,10 ± 14,73 vs. 110,10 ± 14,00; P <0,001) and waist hip (0,87 ± 0,04 vs. 0,84 ± 0,07; P <0;05). In the group receiving a placebo had no significant changes in these variables. Conclusions: Hormonal therapy with drospirenone / 17 β-estradiol was associated with a significant reduction in body weight, body mass index, waist circumference and waist-hip ratio after 6 months of treatment in postmenopausal women, with few or mild side effects.

Effects of hormone therapy on the endometrium in postmenopausal women: a one year randomized trial of low dose oral estradiol in association with a levonorgestrel-releasing intrauterine system or drospirenone / Efeitos da terapia hormonal no endométrio de mulheres na pós-menopausa: estudo clínico randomizado por um ano com estradiol oral em baixa dosagem em associação com sistema intrauterino com levonorgestrel ou drospirona

To compare the endometrial effects and uterine bleeding patterns associated with treatment using (1) levonorgestrel-releasing intrauterine system (LNG-IUS) and estradiol (1 mg/day, p.o.) or (2) orally administered drospirenone (2 mg/day) andestradiol (1 mg/day). METHODS: thirty-four patients (aged 52.53 ± 4.44 in the LNG-IUS group and 53.15 ± 4.018 in the DRSP group) were randomized. The severity of menopausal symptoms was evaluated using the Kupperman index every three months. Transvaginal ultrasound, hysteroscopy and histological evaluation were repeated after 12 months. During this period, patients kept menstrual calendars. All categorical variables were described as percentages. Variables were tested for normal distribution and Student's t test was applied for independent samples and ANOVA forrepeated measures when appropriate. Data were considered to be significant when p<0.05. RESULTS: slight vaginal bleeding was reported in the first month of treatment by 53.3 percent of patients from the LNG-IUS/estradiol group compared with 7.7 percent of patients from the drospirenone/estradiol group. There were no differences in endometrial thickness between the two groups throughout the study period. End-of-study histological findings showed atrophic endometrium in 53.3 percent of patients in the LNG-IUS/estradiol group compared with 76.9 percent of patients in the drospirenone/estradiol group. CONCLUSIONS: our results suggest good endometrial protection with both HT regimens...

Comparar os efeitos endometriais e no padrão de sangramento uterino de tratamento com (1) sistema intrauterine com levonorgestrel (SIU-LNG) e estradiol (1 mg/dia, v.o.) ou (2) associação oral de drospirenona (DRSP) (2 mg/dia) e estradiol (1 mg/dia). MÉTODOS: trinta e quatro pacientes (idade 52,53 ± 4,44 grupo SIU-LNG e 53,15 ± 4,018 grupo DRSP)foram randomizadas. A gravidade dos sintomas menopausais foi avaliado pelo índice de Kupperman a cada três meses. Ultrassom transvaginal, histeroscopia e avaliação histológica foram repetidos após 12 meses. Durante este período, as pacientes fizeram registros em calendários menstruais. Todas as variáveis categóricas foram descritas como porcentagens. Variáveis foram testadas para distribuição normal e teste t de Student para amostras independents e ANOVA para medidas repetidas foram utilizados quando apropriado. Significância estatística foi considerada para p<0.05. RESULTADOS: leve sangramento vaginal foi relatado no primeiro mês de tratamento por 53,3 por cento das pacientes do grupo SIU-LNG/estradiol vs. 7,7 por cento das pacientes do grupo drospirenona/estradiol. Não houve diferença na espessura endometrial entre os grupos durante o periodo do estudo. Os achados histológicos ao final do estudo motraram endométrio atrófico em 53,3 por cento das pacientes no grupo SIU-LNG/estradiol vs. 76,9 por cento das pacientes no grupo drospirenona/estradiol. CONCLUSÕES: nossos resultados sugerem boa proteção endometrial com ambos os tratamentos de terapia hormonal...

Simultaneous determination of ethinyl estradiol and drospirenone in oral contraceptive by high performance liquid chromatography

A simple, rapid, economical and reliable high performance liquid chromatographic method has been developed and successfully applied in simultaneous determination of ethinyl estradiol and drospirenone in coated tablets. The HPLC method was performed on a LiChroCART® 100RP column (125x4 mm i.d., 5 µm) with acetonitrile:water 50:50 (v/v) as mobile phase, pumped at a flow rate of 1.0 mL.min-1. The fluorescence detection for ethinyl estradiol was made at λex= 280 nm and λem= 310 nm and a UV detection for drospirenone was made at 200 nm. The elution time for ethinyl estradiol and drospirenone were 4.0 and 5.7 min, respectively. The method was validated in accordance to USP 34 guidelines. The proposed HPLC method presented advantages over reported methods and is suitable for quality control assays of ethinyl estradiol and drospirenone in coated tablets.

Um método simples, rápido, econômico e confiável foi desenvolvido empregando a cromatografia líquida de alta eficiência para a determinação simultânea de etinilestradiol e drospirenona em comprimidos revestidos. O método foi realizado utilizando coluna LiChroCART® 100RP (125 x 4 mm d.i., 5 µm), a fase móvel constituída de acetonitrila:água, 50:50 (v/v) com vazão de 1,0 mL.min-1. A detecção foi realizada empregando fluorescência em λex= 280 nm e λem= 310 nm para o etinilestradiol e na região de UV em 200 nm para a drospirenona. O etinilestradiol e a drospirenona tiveram tempo de retenção de 4,0 e 5,7 min, respectivamente. O método foi validado de acordo com as diretrizes da USP 34. O método proposto apresentou vantagens sobre os relatados na literatura e pode ser considerado adequado para o controle de qualidade do etinilestradiol e da drospirenona em comprimidos revestidos.

Experiencia piloto con el uso extendido de un anticonceptivo oral combinado de baja dosis de estrógeno / Extended use of an oral combined contraceptive pill with low estrogen dose: pilot experience

Objetivo: Evaluar en una experiencia piloto la aceptabilidad y bienestar de la usuaria, después de un periodo de 12 meses de un anticonceptivo hormonal combinado oral de baja dosis estrogénica, con modalidad de uso extendido de 84 píldoras activas consecutivas, seguidas de 7 días de placebo. Método: Se incorporan 25 mujeres voluntarias que usan una combinación de 20 ug de etinilestradiol + 3 mg de drospirenona, con un tiempo de uso de 12 meses. En calendario de registro diario se consignan los días de sangrado o goteo genital así como todo tipo de fármaco ingerido. Al término de los 12 meses se efectúa una encuesta respecto al grado de satisfacción con la posología recibida. Resultados: 13 usuarias (52 por ciento) cumplen los 12 meses de uso. Todas ellas manifiestan un alto grado de conformidad, destacando las ventajas de presentar periodos menstruales ocasionales, mejoría marcada en la sintomatología compatible con el síndrome de tensión premenstrual con el consiguiente incremento del bienestar general. Siete usuarias (28 por ciento) no terminan el estudio por razones médicas, siendo 6 de estas por alteraciones de los flujos rojos y en 5 casos (20 por ciento) se producen retiros no médicos. Conclusión: Esta experiencia, que es la primera con la formulación descrita, confirma en un porcentaje de usuarias las bondades adicionales reportadas en las experiencias previas con otros productos similares, respecto al uso extendido de anticoncepción hormonal oral en un grupo de mujeres que deseaban espaciar sus periodos menstruales.

Objetives: A pilot study designed in order to know about the acceptability of an oral combined contraceptive pill, with low estrogen dose used in an extended way of 84 consecutive days, followed by 7 days of no pills ingestion during a scheduled follow up of 1 year. Methods: 25 volunteers women were recruited among those which wants to use oral combined contraceptive pills and who accepted this extended way of use. Combined contraceptive pills contains each 20 ug of ethinylestradiol plus 3 mg of drosperinone. At admission women were provided with menstrual diary cards in order to check all bleeding days plus any extra pharmaceutical compound received. At the end of the 12 months follow up an interview was done in order to know women experiences and acceptability of this extended way of use. Results: 52 percent of women end the study at the scheduled 12 months use. All of them feel that the main advantages of these extended way of use were to have few menstrual periods and improving premenstrual symtomatology with better quality of life. 7 women (28 percent) did not finish the study because of medical reasons being due in 6 of these for bleeding disturbances. Conclusions: This report is pioneer with the use this hormone combination in this extended type way of use. Results confirm previous positive reports experiences using another similar hormonal compounds with this extended way of use in women who want to reduce the interval of their menstrual periods.

Efecto de un anticonceptivo oral con drospirenona/etinilestradiol (3 mg - 30 mg) sobre el hiperandrogenismo clínico y bioquímico en pacientes con síndrome de ovario poliquístico / Effect of an oral contraceptive containing drospirenone / ethinyl estradiol (3 mg - 30 mg) on the clinical and biochemical hyperandrogenism in patients with polycystic ovary syndrome

El síndrome de ovario poliquístico es un desorden heterogéneo de etiología incierta, que cual afecta entre el 6% y 10% de las mujeres en edad reproductiva. Una de las opciones terapéuticas especificas es el uso de los anticonceptivos orales, con la progestina, drospirerona, la cual, es un análogo de la espironolactona que posee actividad antimineralcorticoides y antiandrogénica. El objetivo de este estudio fue determinar el efecto del anticonceptivo oral combinado (EE: 30 MG y DRP: 3 mg) en el perfil bioquímico y clínico en una población de mujeres venezolanas con síndrome de ovario poliquístico. De las 20 pacientes incluidas en el estudio, 18 completaron satisfactoriamente el estudio, con una buena tolerancia al tratamiento. Se observó una disminución del IMC de 23,94 en condición basal a 23,73 kg/m². Los niveles de andrógenos se encontraron disminuidos significativamente en comparación a la basal; testosterona total cayó de 1,4 ng/mL a 0,67 ng/mL; Testosterona libre bajo de 3 pg/mL a 1,38 pg/mL; DHEAS disminuyó de 1,65 µg/mL a 1,08 µg/mL y androstenediona de 2,50 ng/mL a 1,55 ng/mL. En conclusión nuestros resultados reportan que el uso de un anticonceptivo oral que contiene 30 mg de EE y 3 mg de progestina, drospirerona en una población de mujeres venezolanas con síndrome de ovario poliquístico condujo a una disminución de los niveles de andrógenos al mismo tiempo que se evidenció un incremento de la SHBG, así como una reducción no significativa del peso corporal de este grupo de pacientes y una mejoría clínica del hirsutismo.

Policystic ovarian syndrome is a heterogeneous disorder wich etiology remained uncertain and affects 6%-10% of reproductive age women. Most recommended therapy is oral contraceptives with progestins. Drospirenone is an espironolactone analogue exhibits a partial antiandrogenic action and has predominant anti-mineralocorticoid properties. This is a prospective trial to determine efficacy of a drospirenone-containing combined oral contraceptives in venezuelan women with polycystic ovary-syndrome. Twenty women were conducted into this trial, although 18 were treated. With treatment, BMI fell by 0,21 kg/m(2) in the study group. During therapy, the levels of testosterone, free testosterone, Delta (4)-androstenedione, and androstenedione decreased significantly, whereas sex hormone-binding globulin increased significantly. Treatment of women with polycystic ovary-syndrome with drospironene containing combined oral contraceptives formulations is effective in decreasing hirsutism, androgen levels and BMI.

Serum Concentration of Estradiol and Estrone Following Oral Administration of Low-dose Hormone Therapy in Postmenopausal Korean Women / 대한폐경학회지

OBJECTIVES: To determine the baseline serum concentrations of estradiol and estrone in postmenopausal Korean women and the serum concentrations of estradiol and estrone after 4 and 16 weeks of treatment using 1 mg of estradiol and 2 mg of drospirenone. METHODS: This was a multicenter study. Thirty-six subjects were screened. Serum estradiol, estrone and drospirenone levels were determined by gas chromatography-mass spectrometry and radioimmunoassay. RESULTS: The mean estradiol concentration was 8.37 +/- 12.1 pg/mL at baseline and increased to 53.7 +/- 52.1 and 41.4 +/- 26.1 pg/mL after 4 and 16 weeks of treatment, respectively. The mean estrone concentrations were 28.7 +/- 26.8, 266.1 +/- 182.9, and 256.1 +/- 179.1 pg/mL at baseline, and after 4 and 16 weeks of treatment, respectively. When women were stratified according to the basal estradiol level, the level after 4 weeks of treatment was significantly higher in the women with a detectable level (> or = 5 pg/mL) than in women with an undetectable level (< 5 pg/mL; 65.2 +/- 21.5 vs. 37.4 +/- 25.8 pg/mL, P = 0.008). After 16 weeks of treatment, the estradiol level was still higher in the detectable group (51.6 +/- 28.6 vs. 38.7 +/- 21.7 pg/mL, P = 0.09). CONCLUSION: This study showed that 1 mg of estradiol and 2 mg of drospirenone is an appropriate regimen to achieve the desired serum estradiol level. The difference in serum hormonal levels after 4 weeks of treatment could be caused by different basal levels.

Effects of Drospirenone (2 mg) with 17beta-estradiol (1 mg) on Blood Pressure, Body Weight, and Lipid Profiles in Postmenopausal Korean Woman / 대한폐경학회지

OBJECTIVES: The objective of the present study was to determine the effects of the widely used combination hormone therapy, drospirenone and 17beta-estradiol on the blood pressure, body weight, lipid profiles, and major side effects in postmenopausal Korean women. METHODS: Four hundred seventeen menopausal patients who were being treated with drospirenone/17beta-estradiol at the Asan Medical Center between December 2007 and October 2010 underwent a retrospective chart review. One hundred twenty-five patients were divided into 2 groups based on blood pressure, as follows: group 1 (normal blood pressure, n = 76); and group 2 (stage 1 hypertension and pre-hypertension, n = 49). The systolic and diastolic blood pressure and the body weight were checked before the treatment, and 1, 2, 3, 6, 9, 12, 18 and 24 months after taking the medication. RESULTS: The median days of administration were 279. The combination of drospirenone and 17beta-estradiol had a blood pressure-lowering effect in groups 1 and 2. However, the body weight did not show a statistically significant change. Only the level of triglycerides decreased with time and the change was statistically significant. The low density lipoprotein (LDL)-cholesterol and triglycerides levels had a statistically significant decrease 18 months after the medication. The most common reasons for discontinuouing medication were vaginal spotting (28%), fear of side effects (27%), and ineffectiveness (26%). CONCLUSION: The combination of drospirenone/17beta-estradiol caused a decrease in systolic and diastolic blood pressure and the body weight showed no statistically significant decrease. Furthermore, triglycerides showed statistically significant decrease and there were no severe side effects of the medication reported.