Micrograms Of Ethinyl Estradiol Research Articles

Experience of using drospirenone/ethinyl estradiol combination in women of reproductive age

Introduction. A woman’s unwillingness to enter pregnancy due to social and somatic factors is associated with a high risk of its termination and concomitant complications. A personalized selection of a method of contraception is necessary, which best meets the needs of a woman, including in achieving non-contraceptive effects.Aim. To evaluate the effectiveness, safety and compliance indicators when using a combined drug (3 mg of drospirenone + 20 mcg of ethinyl estradiol) in women in the early and mature reproductive period.Materials and methods. A study involving 68 women (polycystic ovary syndrome (PCOS), n = 31, adenomyosis, n = 20, uterine fibroids, n = 7, a combination of 2 or more diagnoses) was conducted on the basis of the Scientific polyclinic Department of the V.I. Kulakov National Research Medical Center of the Ministry of Health of the Russian Federation) of reproductive age (18–34 years) who took a combined contraceptive drug for 6 months or more. The control of the results was carried out on the basis of monitoring in the form of a survey.Results. The average time of use of the drug was 9 (Q₁–Q₃: 8–11) months. After 3 and 6 months, 77.8% (21/27) and 100% of the observed patients, respectively, noted a decrease in the severity of PMS symptoms. 91.7% (n = 11/12) of patients noted a subjective decrease in the severity of acne and/or hirsutism after 6 months. 91.3% (n = 21/23) of women with copious painful menstruation noted normalization of the bleeding profile (volume of menstrual blood loss). 95.6% (65 patients out of 68) noted 100% compliance in the use of the drug.Conclusions. The drug Dimia has a favorable profile of clinical and pharmacological safety and efficacy, along with the complete reversibility of contraceptive action when actualizing the issue of the realization of reproductive function. The advantages of the drug are to achieve well-studied non-contraceptive effects, in which patients with PCOS, internal endometriosis and uterine fibroids are interested, in the form of relieving manifestations of PMS and reducing the severity of dysmenorrhea, as well as cosmetic skin imperfections (acne-type rashes, hirsutism). Thus, the drug can be recommended to women of reproductive age as a reliable contraceptive, as well as to achieve non-contraceptive effects.

Drug-Drug Interaction Potential of Mavacamten with Oral Contraceptives: Results from a Clinical Pharmacokinetic Study and a Physiologically Based Pharmacokinetic Model.

Mavacamten is a potential inducer of cytochrome P450 (CYP) 3A4 and, as such, could reduce the exposure of the active components of oral contraceptives, ethinyl estradiol (EE) and norethindrone (NOR), where CYP3A4 is involved in metabolism. This study assessed if repeat doses of mavacamten led to a drug-drug interaction with EE and/or NOR. This was an open-label study in healthy women. In Period 1, participants received 35mcg of EE and 1 mg of NOR. In Period 2, participants received oral loading doses of mavacamten 25 mg on Days 1-2, 15 mg/day on Days 3-17, and 35 mcg of EE and 1 mg of NOR on Day 15. Plasma concentrations of mavacamten, EE, and NOR were obtained before dosing and up to 72 hours after dosing. For EE only, a physiologically based pharmacokinetic model was used to simulate mavacamten-mediated CYP3A4 induction with EE for various CYP2C19 phenotypes. In total, 13 women were enrolled (mean age, 38.9 [standard deviation, 9.65] years). After mavacamten administration, modest increases in area under the concentration-time curves were observed for both EE and NOR. The maximum concentrations and half-lives for EE and NOR were not affected by coadministration with mavacamten. Criteria for bioequivalence were met or nearly met for EE and NOR exposure with geometric mean ratios between 0.8 and 1.25. All adverse events were mild. The physiologically based pharmacokinetic model predicted a less than 15% decrease in EE exposure across CYP2C19 phenotypes. Coadministration of mavacamten at a therapeutically relevant dose with EE and NOR did not decrease the exposure to either EE or NOR to a level that may lead to reduced effectiveness.

Control of side effects in strategy for increasing adherence to combined oral contraceptives. The role for a three-phase desogestrel-containing drug

Introduction. The frequency of side effects when taking combined oral contraceptives (COCs) is still high, which is the reason for refusal to take COCs by women worldwide with a frequency of 30 to 81 %. Management of side effects will help increase the user's adherence to the chosen method of contraception.Aim: to identify approaches to prevent users from refusing to take COCs due to side effects and increase adherence to their use.Materials and Мethods. The search for foreign literary sources in English was carried out in the international bases PubMed/MEDLINE, Google Scholar, Cochrane Library, in Russian in еLibrary database, by keywords: «hormonal contraception», «combined oral contraceptives», «side effects», «adherence». Search depth was 30 years (1992–2022). 437 and 74 articles were identified, respectively, of which the review included 44 manuscripts that satisfied the criteria for inclusion on the topic studied: full-text manuscripts with the results of original studies, systematic reviews and meta-analyses.Results. In the literature, there is a lower incidence of side effects of COCs containing 30–35 µg of ethinylestradiol (tri- and monophasic) compared with 20 micrograms of ethinylestradiol. It was found that the risk of intermenstrual bleeding is 30 % lower when using COCs containing thirdgeneration progestogens compared with second-generation progestogens (relative risk (RR) = 0.71; 95 % confidence interval (CI) = 0.55–0.91) using monophasic combinations as an example. The use of a three-phase COC containing desogestrel (DSG) was characterized by a low incidence of irregular bleeding (3.3 % in the first cycle and a decrease to 2.3 % by the 12th cycle), no effect on physiological parameters, a decrease in blood androgens content and a positive effect on seborrhea and acne, excellent tolerance (2.6% failures due to adverse events). Three-phase COCs are characterized by a lower frequency of intermenstrual bleeding (by 2 times) and amenorrhea (by 3 times) compared with other COCs. A positive effect on reducing the frequency of irregular spotting and breakthrough bleeding was shown when switching from a COC of another composition to a three-phase one containing DSG, and continuing to use it.Conclusion. A three-phase COC containing DSG continues to be a topical hormonal contraceptive for women both for the first time and when switching from another COC due to side effects, including those associated with menstrual irregularities.

Estrogen Supplementation Is Associated With Higher Quality of Life Scores in Women With Cystic Fibrosis

Abstract Purpose: With rapid advancements in therapeutic options for patients with cystic fibrosis (CF), the median predicted survival has increased to 47 years along with the prevalence of non-pulmonary complications for patients with CF. Women with CF suffer irregular menses, sexual dysfunction and low bone mineral density. With increasing pregnancies among women with CF, they may consider contraception. Estrogen supplementation may modulate these outcomes and others. The purpose of this study was to explore the effects of supplemental estrogen use on quality of life (QOL) in CF. Methods: Women with CF ages 16-50 years were administered a validated CF-specific QOL survey (CFQ-R) during a routine CF clinic visit through an IRB-approved cross-sectional study. The QOL domain scores of subjects taking and not taking estrogen were compared pairwise by Kruskal Wallis tests and overall by Wilcoxon signed rank test. Results: The estrogen exposed and estrogen unexposed subjects with CF had similar age, BMI, FEV1, race, CF mutation, pancreatic insufficiency, diabetes and relationship status. The estrogen exposed subjects were taking 20-30 mcg of ethinyl estradiol in oral contraceptive pills. The estrogen exposed subjects had consistently higher QOL scores than the estrogen unexposed subjects (p=0.001). The estrogen exposed subjects had significantly higher scores in 7 of the 12 CFQ-R categories: physical, vitality, treatment burden and role domains and weight, respiratory and digestion symptom scales (p<0.05). When correcting for multiple comparisons, the estrogen-supplemented women had higher role domain scores than women not taking estrogen supplement (p=0.03). Conclusions: Estrogen supplementation was associated with improved quality of life in women with CF. This cross-sectional study highlights the need for further investigation into the potential benefits of estrogen supplementation. The dose, route, formulation and timing of estrogen therapy may modulate the beneficial effects for women with CF. Support: This work was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award TL1TR002382 and UL1TR002378, and Cystic Fibrosis Foundation award WU20D0. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or CFF.

SODIUM ACETATE ATTENUATES MYOCARDIAL TRIGLYCERIDE ACCUMULATION IN COMBINED ORAL CONTRACEPTIVE-TREATED RATS BY SUPPRESSING ADENOSINE DEAMINASE/XANTHINE OXIDASE-DEPENDENT PATHWAY

Objective: Myocardial triglyceride accumulation characterizes many cardiovascular disorders. Cardiovascular disorders are the leading cause of mortality and morbidity worldwide. Continuous usage of Combined Oral Contraceptive (COC) has been associated with disrupted lipid metabolism, however, the exact mechanism is not clear. Adenosine Deaminase (ADA) and Xanthine Oxidase (XO) are reportedly involved in cardiometabolic derangement, particularly lipid dysmetabolism. We, therefore hypothesized that increased ADA and XO activities and elevated uric acid level are involved in COC-induced myocardial triglyceride accumulation. This study also aimed at investigating the ameliorative effects of sodium acetate on COC-induced myocardial lipid accumulation in female Wistar rats. Design and method: Female Wistar rats received vehicle per ostium (p.o.) and COC (1.0 microgram of ethinylestradiol plus 5.0 microgram of levonorgestrel; p.o.) with or without sodium acetate (ACE; 200 miligram/kilogram; p.o.) for 8 weeks (n = 6/group). Insulin resistance was estimated by homeostatic model of assessment whereas glucose tolerance was determined by oral glucose tolerance test. Other biochemical variables were evaluated using standard methods. Data were analysed using one-way analysis of variance followed by Bonferroni's post hoc test. Significant differences were accepted at p < 0.05. Results: Treatment with COC led to increased 1-h postload glucose response, plasma insulin, triglyceride-glucose index, insulin resistance and impaired glucose tolerance. COC treatment also resulted in increased plasma and cardiac free fatty acid, triglyceride, triglyceride/high density lipoprotein-cholesterol ratio, malondialdehyde, uric acid, ADA and XO activities. On the other hand, COC led to reduction in nitric oxide level. However, sodium acetate significantly ameliorated the alterations induced by COC treatment, but XO activity remains elevated during COC treatment. Conclusions: Therefore, sodium acetate would impact positively on myocardial lipid accumulation-related cardiovascular disorders, at least in part, by suppression of adenosine deaminase/xanthine oxidase/uric acid-dependent pathway.

Impact of Cyproterone Acetate and Ethinylestradiol on Clomiphene Resistant PCOS Patient with High Serum AMH level

Background: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women of reproductive age. PCOS is characterized by hyperandrogenism and oligomenorrhea, and Polycystic ovary .It is a common cause of female subfertility. Anti-mullerianhormone (AMH) is 2-4 times higher in patients with PCOS compared to normal subfertilety patient.
 Objective: To assess the impact of metformin and oral contraceptives (OCs) containing cyproterone acetate and ethinyl estradiol on serum anti-Mullerian hormone (AMH) levels, with CC resistant polycystic ovary syndrome (PCOS)
 Methods: This prospective randomized controlled trial was conducted at Bangabandhu Sheikh Mujib Medical University(BSMMU), Dhaka during the preoid of January 2019 to june 2019. Already diagnosed patients of polycystic ovary syndrome with subfertility with high serum AMH level more than 5 ng/ml attending in the OPD of Reproductive Endocrinology and infertility department at BSMMU are the study population. Total 60 subjects fulfilling rotardum criteria and who are treated with 3 cycle CC with 100mg /day for 5 days from day 2 of menstrual cycle but fail to ovulate were recruited for the current study. Those subjects with tubal, and male factors excluded from the study. .After enrollment of the patients, randomization will be carried out by blocked randomization method to divide them equally into two groups-Group A number of patients 30 ( treated with2mg cyproterone acetate (CPA) and 35 mcg of ethinylestradiol (EE) and Group B number of patients 30 treated with Metformin). Group A patients will receive treatment with 2mg cyproterone acetate (CPA) and 35 mcg of ethinylestradiol (EE) for 6 months and Group B patients will receive treatment with Metformin for 6 months . After enrollment of the patients, base line hormonal assessment basal level of FSH, LH ,thyroid-stimulating hormone (TSH), prolactin (PRL), and testosterone hormones were registered and metabolic assessment included OGTT and fasting insulin level were done, and to identify the changes in clinical and biochemical profile of study population. Clinical evaluation, by history and examination, transvaginal ultrasonography of both group and changes of the above mentioned parameters of both group were recorded after 6 month of completion of treatment.
 Results: A Changes in clinical parameters (Acne, BMI, Menestrual cycle) was recorded every three monthly for 6 month. Changes of biochemical parameters (serum LH (D2), serum FSH (D2), serum testosterone, OGTT and fasting insulin), serum AMH were recorded every three monthly for 6 month. Changes of sonographic parameters (ovarian volume, Antral follicular count development, was done monthly for 6 cycles. AMH levels are significantly reduced under treatment with OCP containing 35mg ethinylestradiol plus 2 mg cyproteroneacetate than metformin. AMH was significantly decreased after treatment with 35 mg ethinylestradiol plus 2 mg cyproterone acetate ( p < 0.001 at 6 months). and treatment with metformin did not significantly affect serum AMH levels. AMH was significantly decreased after treatment with metformin (p < 0.005). Serum LH was and OGTT was significantly decreased in both treatment p<0.001.
 Conclusion(s:) AMH serum levels were significantly decreased under treatment with 35mg ethinylestradiol plus 2mg cyproterone acetate, due to decrease in androgens and suppression of gonadotropins(LH).
 J Shaheed Suhrawardy Med Coll, December 2020, Vol.12(1); 38-44

Creativity and individuality in matters of hormonal contraception

The relevance of the discussion about therapeutic and preventive effects of combined oral contraceptives is caused to the fact that their impact is quite often the primary motivation for the appointment and intake the drugs. “Therapeutic portrait” of the hormonal contraceptive is mainly determined by component of progestin. Knowledge and ability to use the variety of pharmacological effects, metabolic characteristics of progestins and application regimens of combined oral contraceptives allows to achieve the maximum benefit from the appointment of the drug and increases the number of adherents of hormonal contraception among patients and doctors. The authors reveal the possibility of a creative approach to the appointment of combined oral contraceptives on the example of the combination of 30 mcg of ethinyl estradiol and 2 mg of dienogest, which unites the positive properties of 19-nor progestins and progesterone derivatives. A feature of dienogest is high selectivity for the progesterone receptors, absence of estrogenic, anti-estrogenic and androgenic properties, metabolic neutrality, slight suppression of gonadotropin secretion, pronounced anti-proliferative effect on the endometrium. This allows to recommend the preparation containing 2 mg of dienogest and 30 mcg of ethinyl estradiol for contraception of conditionally healthy women during the whole reproductive period, without fear to cause hormonal or metabolic disorders, weight gain, decrease of libido. Non-contraceptive benefits of this combination make it preferable for women who suffer from dysmenorrhea, endometriosis, acne, chronic abnormal uterine bleedings. The decision to choose one or another of drugs is taken individually in each case, taking in attention the severity of clinical manifestations, concomitant somatic and gynecological pathology, previous experience and expectations of patients. However, great importance in the formation of adherence to therapy, particularly in respect of long-term use of schemes, has a price of hormonal contraceptive. The absence of any significant differences in the profiles of the solubility and bioavailability of the generic zhastinda (Alvogen) and original drug allows to reckon them as bioequivalent and makes dienogest in combination with ethinyl estradiol the most available drug for the consumer.

Abnormal Uterine Bleeding: American College of Nurse-Midwives.

Variations in uterine bleeding, termed abnormal uterine bleeding, occur commonly among women and often are physiologic in nature with no significant consequences. However, abnormal uterine bleeding can cause significant distress to women or may signify an underlying pathologic condition. Most women experience variations in menstrual and perimenstrual bleeding in their lifetimes; therefore, the ability of the midwife to differentiate between normal and abnormal bleeding is a key diagnostic skill. A comprehensive history and use of the PALM-COEIN classification system will provide clear guidelines for clinical management, evidence-based treatment, and an individualized plan of care. The purpose of this Clinical Bulletin is to define and describe classifications of abnormal uterine bleeding, review updated terminology, and identify methods of assessment and treatment using a woman-centered approach.

ROLE OF CONTRACEPTION IN IMPROVING WOMEN´S QUALITY OF LIFE ASSOCIATED WITH PMS AND OTHER MENSTRUAL DISORDERS

Objective – to assess the quality of life (QOL) of women with premenstrual syndrome (PMS) from moderate to severe degree in combination with other symptoms of the menstrual cycle with use of the combined oral contraceptive containing 20 mcg of ethinyl estradiol (EE) and 3 mg of drospirenone (DRSP) under scheme 24/4. Material and methods. A single-center, prospective, cohort, non-randomized, uncontrolled study was conducted. On the basis of screening of 360 women 27 patients with PMS of moderate and severe forms were selected. The control group consisted of 18 women without PMS. Diagnosis of PMS was based on standardized ICD-10 criteria, the psychological state was assessed by the hospital anxiety and depression scale HADS, QOL index – by the short form of the SF-36 questionnaire. The evaluation was carried out twice – before beginning treatment and in 3 months after the treatment. Results. Assessment of QOL showed that as compared with the baseline parameters they significantly improved in 3 months of treatment by scales that assess PP (physical pain: 56.0 ± 28.9 vs 76.2 ± 18.9, p = 0.020), RE (role of emotional problems in limitation of life activity: 57.8 ± 21.3 vs 77.9 ± 18.3, p = 0.040), SA (social activity: 42.5 ± 13,5 vs 72,5 ± 12,8, p = 0.050) and MH (mental health: 62,0 ± 7,3 vs 72.0 ± 6.3, p = 0.048). 88.4% of the subjects expressed high satisfaction with the treatment results. Conclusion. Symptoms of PMS and other disorders of the menstrual cycle successfully stopped for 3 months by a combination of 20EE/DRSP, which is accompanied by a reduction in the incidence of anxiety and depression and improving in QOL.

Effects of a combined oral contraceptive containing 20 mcg of ethinylestradiol and 3 mg of drospirenone on the blood pressure, renin-angiotensin-aldosterone system, insulin resistance, and androgenic profile of healthy young women

Combined oral contraceptives (COCs) may increase the risk for cardiovascular disease depending on the ethynyl estradiol (EE) dose and the androgenicity of the progestogens. Our objective was to evaluate the impact of a COC containing 20 mcg EE + 3 mg drospirenone on blood pressure (BP), renin-angiotensin-aldosterone system, insulin resistance, and androgenic profile of healthy young women. Eighty-one healthy young women aged 30 ± 1 years (case group, n = 49, received COC; control group, n = 32, used no COC) were assessed twice, before and after the 6-month study. Statistical analysis employed the paired t-tests and expressed the data in mean and standard deviation. Results were as follows: no changes in BP or in BMI; a significant increase in aldosterone, plasma renin activity, triglycerides, and total cholesterol levels, but a non-significant increase in HDL and no significant changes in LDL levels (these parameters remained within normal ranges); a significant increase in the HOMA-IR index and a significant decrease in dehydroepiandrosterone sulfate (SDHEA), androstenedione, total testosterone, and free testosterone levels; no significant variations in the control group parameters. An oral contraceptive combination of a low EE dose and an anti-androgenic progestogen does not negatively influence the risk factors for a cardiovascular disease.

Вибір гормональної контрацепції у жінок репродуктивного віку інфікованих вірусом папіломи людини

Aim and Methods. To address the issue of selection of hormonal contraception in women of reproductive age who are infected with human papilloma virus (HPV) were carried out immunohistochemical studies of the tissues of the cervix to determine the level of estrogen (ER) and progesterone receptor (PR) and their ratio at 120 women diagnosed with HPV-high risk types (16,18, 32,33 types) and 120 healthy women who is OK with different content of ethinyl estradiol. Results and conclusions. The results showed that the use of ultra-low-dose oral contraceptives containing 15-20 mcg of ethinyl estradiol can be recommended as the optimal method of hormonal contraception in women of reproductive age who are infected with human papilloma virus (HPV).

Metabolic Profiles in Phase 2 Study of Two 21/7 Oral Contraceptive Regimens (±7 Hormone-Free Days)

INTRODUCTION: Metabolic changes observed in women taking combined oral contraceptives may vary depending on the dose and regimen of the combined oral contraceptive components. METHODS: We compared metabolic profiles (secondary endpoints) in women enrolled in a multinational randomized parallel-group open-label study comparing a 21-day combined oral contraceptive regimen containing 150 micrograms desogestrel and 20 micrograms ethinyl estradiol followed by 7 days of 10 micrograms of ethinyl estradiol (Lecette; Treatment 1) compared with a traditional combined oral contraceptive with 7 no treatment (hormone-free) days (Treatment 2). Healthy women aged 18-40 years with regular menstrual cycles and no contraindications to estrogens progestins or both received one of the two combined oral contraceptive regimens for six consecutive 28-day cycles. Serum total cortisol cortisol-binding globulin thyroid-stimulating hormone and sex hormone-binding globulin were measured at baseline and weeks 11 and 23. RESULTS: Of 293 women randomized 246 comprised the per-protocol population (Treatment 1: n=125; Treatment 2: n=121). Mean baseline metabolic parameters were similar for both groups. Increases in mean total cortisol cortisol-binding globulin and sex hormone-binding globulin evident by week 11 were similar with both combined oral contraceptives through week 23. Overall least square mean changes+/-standard errors for Treatments 1 and 2 were 239.0+/-15.7 and 230.8+/-16.0 nmol/L respectively for total cortisol (P=.71) and 40.8+/-1.6 and 37.2+/-1.6 mg/L for cortisol-binding globulin (P=.11); overall sex hormone-binding globulin rose by 163.4+/-7.3 and 149.1+/-7.5 nmol/L (P=.17). Neither group had clinically relevant changes in thyroid-stimulating hormone. CONCLUSIONS: Observed total cortisol cortisol-binding globulin and sex hormone-binding globulin increases in women taking a 21/7 combined oral contraceptive regimen followed by either 7 days of 10 micrograms ethinyl estradiol or 7 hormone-free days were similar.

Return to Ovulatory Capacity With Three Combined Oral Contraceptive Regimens

INTRODUCTION: This study was designed to evaluate the effect of the combined oral contraceptive regimen LeCette (150 micrograms desogestrel and 20 micrograms ethinyl estradiol for 21 days followed by 10 micrograms of ethinyl estradiol for 7 days) and two different 28-day combined oral contraceptives on ovulation inhibition and return to ovulatory capacity. METHODS: In this phase 1, randomized, open-label comparative study, healthy, nonsmoking women aged 18–35 years with regular menstrual cycles were randomized to receive one of three combined oral contraceptives for three consecutive 28-day cycles. The three combined oral contraceptives evaluated were 21 days desogestrel and ethinyl estradiol followed by 7 days of ethinyl estradiol (desogestrel and ethinyl estradiol+ethinyl estradiol); 24 days of 3 mg drospirenone and 20 micrograms ethinyl estradiol followed by 4 placebo days (drospirenone and ethinyl estradiol and placebo); and 21 days of 100 micrograms levonorgestrel and 20 micrograms ethinyl estradiol followed by 7 placebo days (levonorgestrel and ethinyl estradiol+placebo). The proportion of women who returned to ovulatory capacity after combined oral contraceptive discontinuation was a secondary endpoint. Ovulatory capacity was defined as serum progesterone concentrations of at least 15.9 nmol/L on posttreatment cycle days 18, 19, or 20. RESULTS: A total of 206 women were randomized, 146 were evaluated for safety, and 142 were evaluated for efficacy. Greater ovarian suppression and ovulation inhibition were observed with desogestrel and ethinyl estradiol+ethinyl estradiol and drospirenone and ethinyl estradiol+placebo compared with levonorgestrel and ethinyl estradiol+placebo during the study. Return to ovulatory capacity occurred in approximately 76% desogestrel and ethinyl estradiol+ethinyl estradiol, 75% drospirenone and ethinyl estradiol+placebo, and 58% levonorgestrel and ethinyl estradiol+placebo of women. Adverse events were comparable among groups and consistent with those observed with other combined oral contraceptives. CONCLUSION: Regimens with altered or eliminated hormone-free intervals provided greater ovarian suppression with little delay in return to ovulatory capacity.

Качество жизни женщин с предменструальным синдромом в динамике лечения негормональными и гормональными препаратами

PMS may have a negative impact on the daily lives of women, leading to various disorders. Objective: based on the survey results with general international questionnaire MOSSF-36 in order to examine the quality of life (QOL) of patients with PMS ranging from average to severe, before and after treatment with herbal remedies, on the basis of dry extract of Vitex agnus castus and oral hormonal contraceptives (COC) containing 20 mcg of ethinyl estradiol and 3 mg of drospirenone in a 24+4 regimen.We observed 243 patients aged 16 to 45 years, of mean age of 29,7±5,8 years, and an average degree of heavy PMS has been identified and confirmed by ICP-diaries. To assess the quality of life and ICP influence on the physical and psychological aspects of life in patients the late luteal phase of the menstrual cycle twice, before and after treatment, filled the general quality of life questionnaires Medical Outcomes Study - Short Form (MOSSF-36). After treatment the statistically significant decrease in deformation parameters, both physical and psychological components of health was shown.Conclusion. Treatment of women with PMS and the average degree of severe type with herbal remedies, on the basis of dry extract of prostrata ordinaryextract and COC containing 20 mcg of ethinyl estradiol and 3 mg of drospirenone in 24+4 regimen has led to the improvement of the patients, as well as their quality of life, which resulted in a statistically significant decrease in strain indicators of physical and psychological components of health.

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

BackgroundCombined oral contraceptives (COCs) may lead to a rise in cardiovascular disease risk, possibly associated with changes in blood pressure and endothelial function. Study DesignThe 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). ResultsNo 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. ConclusionThese data suggest COC with 20 mcg EE and 3 mg DRSP does not alter arterial endothelial function or hemodynamic parameters in healthy young women.

Effects of extended regimens of the contraceptive vaginal ring on carbohydrate metabolism

BackgroundThere are few publications on the metabolic effects of extended regimens of the contraceptive vaginal ring. The aim of this study was to assess changes in fasting plasma glucose levels and insulin concentration of women using the contraceptive vaginal ring continuously over a 1-year period. Study DesignThis prospective cohort enrolled 75 women (ages 18–37 years) who used a contraceptive vaginal ring releasing 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily continuously for 84 days, followed by a 7-day ring-free interval, during 1 year. Fasting glucose and insulin levels were measured, and homeostatic model assessment was calculated at baseline and every 3 months during the 1-year study period. The repeated-measures analysis of variance test was used to analyze differences in the results of these exams over time. ResultsNone of the 75 participants had results outside the normal range in any of the assessments. There were no pregnancies during the 1-year period, and a total of 62 participants completed the study. There were no significant changes in mean fasting glucose levels (79.3 and 78.9 mg/dL at baseline and after 12 months, respectively), mean fasting insulin concentration (9.6 and 10.1 μU/mL) or mean homeostatic model assessment results (1.88% and 1.97%). ConclusionFasting plasma glucose concentration, insulin levels and homeostatic model assessment values of women using the vaginal ring on an extended regimen did not change significantly over a 1-year period.

Contracepção hormonal: uma comparação entre pacientes das redes pública e privada de saúde

The aim of this paper is to assess the profile of patients using hormonal contraceptives in the public health network and a comparison with the private health service, as well as the frequency of side effects and adherence to treatment. A cross-sectional study was conducted with 240 patients, namely 120 patients from the private health service and 120 patients from the public health network. The most commonly prescribed hormonal dosage on the private group (36.7%) was 15 or 20 micrograms of ethinyl estradiol (EE), associated with gestodene, desogestrel or levonorgestrel. On the other hand, the prescribed hormonal dosage in the public group was a combination of 30 micrograms of EE associated with gestodene, levonorgestrel or desogestrel (48.3%). There was no difference between the frequency of side effects in both groups surveyed (p>0.05). Meanwhile, adherence to treatment was higher in patients of the private group. The authors concluded that the most widely used contraceptive method was a low oral dose of ethinyl estradiol and there is no difference between the frequency of side effects. However, adherence to treatment was higher in the private group, which may be associated with social and cultural aspects of the patients surveyed.

Extended regimens of the combined contraceptive vaginal ring containing etonogestrel and ethinyl estradiol: effects on lipid metabolism

Background Oral contraceptives used for extended periods of time have been studied because of their potential benefits; however, there have been few publications on extended regimens of vaginal contraceptive rings. The aim of this study was to evaluate modifications in the lipid profile of women using the vaginal ring continuously over a 1-year period. Study Design This prospective cohort enrolled 75 women (18–37 years) who used a contraceptive vaginal ring releasing 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily continuously for 84 days, followed by a 7-day ring-free interval, during 1 year. At baseline and every 3 months during the 1-year study period, blood was collected to assess cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides and apolipoproteins A-I and B. The ANOVA test was used to analyze differences in the results of these exams over time. Results After 1 year of continuous contraceptive use, there was a significant increase in triglycerides as well as in total and HDL-C levels. There was a nonsignificant decrease in the mean concentration of LDL-C during the study period. Apolipoprotein A-I increased and apolipoprotein B decreased, but the apolipoprotein A-I/apolipoprotein B ratio did not change significantly. Conclusion The combined contraceptive vaginal ring used on an extended regimen causes changes in the lipid profile metabolism of users. Despite the vaginal route of administration, the steroids released by the ring caused significant changes in lipids and lipoproteins, which were typical of those seen with ethinyl estradiol given either orally or parenterally.

Effect of oral contraceptives on markers of hyperandrogenism and SHBG in women with polycystic ovary syndrome

Background This randomized study's aim was to compare the effect of four oral contraceptives (OCs) containing 30 mcg of ethinylestradiol (EE) and different progestogens [drospirenone, (DRSP), chlormadinone acetate (CMA), desogestrel (DSG), gestodene (GSD)] on biochemical and hormonal parameters of hyperandrogenism and sex hormone-binding globulin (SHBG) in women with polycystic ovary syndrome (PCOS). Study Design Forty women with PCOS (age 16–35 years) were recruited and randomly assigned to one of four treatment groups of 10 women each, treated, respectively, with 3 mg DRSP/30 mcg EE (Yasmin, Bayer Shering), 2 mg CMA/30 mcg EE (Belara, Grunenthal), 75 mcg GSD/30 mcg EE (Minulet, Wyeth Lederle) and 150 mcg DSG/30 mcg EE (Practil 21, Organon Italia). Blood samples were obtained on day 6-8 of the control cycle and day 6-8 of the third treatment cycle for assay of the following hormones: androsteredione (A), total testosterone (T), free T, SHBG, dehydroepiandrosterone sulphate (DHEAS). Results In all groups, mean concentrations of free T, total T and A dropped by 40-60%, and concentrations of DHEAS dropped by 20–50%. Formulations with DRSP and CMA caused a greater reduction of androgens and a progressive increase in serum concentrations of SHBG than those with DSG and GSD. Conclusions Clinical studies need to be performed to determine effects of these OCs upon clinical signs of hyperandrogenism.

Extended regimens of the contraceptive vaginal ring: evaluation of clinical aspects

Background Oral contraceptives used for extended periods of time have been extensively studied because of their potential benefits; however, there have been few publications on extended regimens of vaginal contraceptive rings. The aim of this study was to evaluate the clinical symptoms, body weight and blood pressure changes in women using the vaginal ring continuously over a 1-year period. Study Design This prospective cohort evaluated clinical aspects (dysmenorrhea, headache, breast tenderness, leg pain and irritability), body weight and blood pressure changes in 75 women (18–37 years of age) using a vaginal ring releasing 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily, over a continuous period of 84 days, followed by a 7-day ring-free interval, during 1 year. The chi-square, Wilcoxon and paired t tests were used to analyze differences in the outcomes of interest. Results Compared to pre-enrollment status, at the end of the study period, the patients reported significantly less dysmenorrhea and irritability, a nonsignificant decrease in breast tenderness, leg pain and headaches. Blood pressure measurements remained unchanged. Although weight and body mass index increased significantly among users, they remained within the expected biological variation range. Conclusion The vaginal ring used on an extended regimen is a well-tolerated contraceptive method and also offers noncontraceptive benefits.