Administration Of Oral Contraceptives Research Articles

What are the diagnostic considerations in a menopausal woman with a positive hCG test result?

EVIDENCE-BASED ANSWER The most common causes of elevated human chorionic gonadotropin (hCG) in a menopausal woman are a false-positive test (42%), quiescent gestational trophoblastic disease (GTD; 41%), low level pituitary production (10%), and malignancy (7.6%). After repeating the test in blood and urine, active malignancy and quiescent GTD should be ruled out by obtaining hyperglycosylated hCG and hCG free β-subunit. A physiologic pituitary source of hCG is likely in women with persistent low levels of hCG (<25–32 mIU/mL). This finding can be confirmed by the normalization of hCG levels after the administration of combined oral contraceptives for 2 or more weeks (SOR: C, case series of disease-oriented evidence).

Oral contraceptives augment the exercise pressor reflex during isometric handgrip exercise.

We sought to determine whether oral contraception alters the gender‐related differences observed in the exercise pressor reflex during isometric handgrip exercise. Fifteen men, fifteen normally menstruating women (WomenNM), and fifteen women taking monophasic oral contraceptives (WomenOC) completed two trials of a 3‐min isometric handgrip exercise protocol performed at 30% of their maximal voluntary contraction: (1) where arterial occlusion was applied to the previously exercising arm during a 3‐min recovery period (Occlusion trial); (2) where no arterial occlusion was applied during recovery (Control trial). Handgrip exercise elicited greater increases in mean arterial pressure (MAP) in MEN compared to both female groups (P < 0.05), and in WomenOC compared to WomenNM in both trials (P = 0.01, P = 0.03). After 3 min of recovery, sBP was 12% (P = 0.01) and 9% (P = 0.02) higher in the Occlusion trial when compared to the Control trial for MEN and WomenOC. Conversely, arterial occlusion in recovery from handgrip did not sustain elevated sBP in the Occlusion trial, and sBP returned to recovery levels not different to the Control trial, in WomenNM (P = 0.41). These data indicate that gender‐related differences in the metaboreflex during isometric handgrip exercise exist between men and normally menstruating women, but are blunted when men are compared to women taking oral contraceptives. We conclude that the suppression of 17β‐estradiol and/or progestogen in women via the administration of oral contraceptives attenuates sex‐related differences in the metaboreflex during isometric handgrip exercise.

Oral contraceptive pills as an option for non-surgical management of retained products of conception – a preliminary study

Many Patients with persistent retained products of conception prefers to avoid surgical interventions, such as a dilatation and curettage (D&C) that might pose an additional future risk to their already compromised fertility or obstetric performance. The aim of this study was to the possibility of induced withdrawal bleeding following oral contraceptive administration as a non-surgical treatment for patients with persistent retained products of conception (RPOC). A retrospective study of patients presenting with retained products of conception (RPOC) after failed expectant management or after treatment with PGE1 was performed. Twelve women presenting with RPOC at ≤8 weeks gestation with minimal to mild vaginal bleeding and no signs of infection were treated with oral contraceptive pill (OCP) containing 0.03 mg ethinylestradiol and 0.15 mg of desogestrel for 3 weeks. Out of the 12 patients treated, nine women (75%) successfully expelled the RPOC after completing the three-week course of OCPs. The three cases (25%) that did not resolve following OCP treatment had pregnancy products with positive blood flow on Doppler examination. We conclude that OCPs may be a useful medical treatment option for persisting RPOC in selected patients with absence blood flow on Doppler examination wishing to avoid surgical intervention.

Oxidative stress, plasma/salivary antioxidant status detection and health risk factors

Background: Oxidative stress is involved in the pathophysiology of several diseases such as cardiovascular disorders, cancer, neurodegeneration.Aims and Objectives: Our study evaluated the oxidant/antioxidant status on a cohort of healthy patients matched with some independent variables as a basic individual redox balance monitor on a disease-prevention perspective.Materials and Methods: The anecdotic, retrospective and observational study included 200 apparently healthy volunteers after formal informed consent release whose personal history and physical examination had been recorded specifically on the following items: age, previous diseases, sport activities, smoking habit, balanced/unbalanced nutrition, current absence/presence of inflammatory processes, oral health hygiene, administration of oral contraceptives or hormone replacement therapy in postmenopausal women. No drug treatment was admitted in the recruited patients, up to 6 months before the evaluation. The laboratory instruments used were Point of care FRAS 4 Evolvo (H&amp;D, Parma, Italy) measuring the oxidative stress in plasma samples and antioxidant capacity in plasma and saliva samples.Results: Two-hundred patients were recruited. Statistically relevant differences were observed in oxidative stress-related variables, namely a significant relationship between plasma oxidative stress level and female gender (p&lt;0.01), between saliva antioxidant level and age (p=0.01), between plasma antioxidant level and unbalanced diet (p&lt;0.01), between plasma oxidative stress level and inflammation in the oral cavity (p=0.04), and between saliva antioxidant level and inflammation in the oral cavity (p&lt;0.01).Conclusions: A relationship between oxidative/antioxidant status and health risk factors has been outlined in our study; the achieved data are quite helpful, in the clinical practice, providing additional information on individual general health conditions, putatively related to prevention diagnosis, prognosis, and treatment effectiveness in some specific diseases.Asian Journal of Medical Sciences Vol.8(1) 2017 32-41

Oral contraceptives versus physical exercise on cardiovascular and metabolic risk factors in women with polycystic ovary syndrome: a randomized controlled trial.

Although oral contraceptives (OCs) are one the most widespread therapy in young polycystic ovary syndrome (PCOS) women and physical exercise represents a crucial first step in the treatment of overweight and obese PCOS, no studies were performed to compare the effects on cardiovascular risk (CVR) of OCs and physical exercise in PCOS. To compare the effects of OCs administration and physical exercise on the CVR, clinical, hormonal and metabolic parameters in PCOS women. One hundred and fifty PCOS women were enrolled and were randomized to OCs (3 mg drospirenone plus 30 μg ethinyloestradiol), structured exercise training programme (SETP) or polyvitamin tablets. The intervention phase study was of 6 months. Primary outcome was intima-media thickness (IMT) and flow-mediated dilation (FMD). Secondary outcomes were clinical, hormonal and metabolic changes. A significant reduction of IMT and a significant increase of FMD were observed in the SETP group after treatment. Compared to baseline, in the SETP group, a significant improvement in anthropometric measures, insulin sensitivity indexes, lipid profile, cardiopulmonary function, inflammatory markers and frequency of menses was observed. Oral contraceptives use was associated with a significant decrease of hyperandrogenism and a significant improvement of frequency of menses. Further, OCs use had a neutral effect on CVR risk factors. OCs effectively treat hyperandrogenism and menstrual disturbances, while SETP is more effective in improving cardiometabolic profile and cardiopulmonary function in PCOS.

Oral contraception following abortion: A systematic review and meta-analysis.

Oral contraceptives (OCs) following induced abortion offer a reliable method to avoid repeated abortion. However, limited data exist supporting the effective use of OCs postabortion. We conducted this systematic review and meta-analysis in the present study reported immediate administration of OCs or combined OCs postabortion may reduce vaginal bleeding time and amount, shorten the menstruation recovery period, increase endometrial thickness 2 to 3 weeks after abortion, and reduce the risk of complications and unintended pregnancies.A total of 8 major authorized Chinese and English databases were screened from January 1960 to November 2014. Randomized controlled trials in which patients had undergone medical or surgical abortions were included. Chinese studies that met the inclusion criteria were divided into 3 groups: administration of OC postmedical abortion (group I; n = 1712), administration of OC postsurgical abortion (group II; n = 8788), and administration of OC in combination with traditional Chinese medicine postsurgical abortion (group III; n = 19,707).In total, 119 of 6160 publications were included in this analysis. Significant difference was observed in group I for vaginal bleeding time (P = 0.0001), the amount of vaginal bleeding (P = 0.03), and menstruation recovery period (P < 0.00001) compared with the control groups. Group II demonstrated a significant difference in vaginal bleeding time (P < 0.00001), the amount of vaginal bleeding (P = 0.0002), menstruation recovery period (P < 0.00001), and endometrial thickness at 2 (P = 0.003) and 3 (P < 0.00001) weeks postabortion compared with the control group. Similarly, a significant difference was observed in group III for reducing vaginal bleeding time (P < 0.00001) and the amount of vaginal bleeding (P < 0.00001), shortening the menstruation recovery period (P < 0.00001), and increasing endometrial thickness 2 and 3 weeks after surgical abortion (P < 0.00001, all).Immediate administration of OCs postabortion may reduce vaginal bleeding time and amount, shorten the menstruation recovery period, increase endometrial thickness 2 to 3 weeks after abortion, and reduce the risk of complications and unintended pregnancies.

Efficacy and safety of metformin or oral contraceptives, or both in polycystic ovary syndrome.

BackgroundPolycystic ovary syndrome (PCOS) is an endocrinopathy that affects approximately 10% of reproductive-aged women throughout their lives. Women with PCOS present with heterogeneous symptoms including ovulatory dysfunction, hyperandrogenism, and polycystic ovaries. Therefore, lifelong individualized management should be considered. Pharmacological agents commonly used to manage the symptoms are metformin and oral contraceptive pills. Although these medications have been beneficial in treating PCOS symptoms, their efficacy and safety are still not entirely elucidated. This study aimed to report the efficacy and safety of metformin, oral contraceptives, or their combination in the treatment of PCOS and to define their specific individual roles.MethodsA literature search of original studies published in PubMed and Scopus was conducted to identify studies comparing metformin with oral contraceptives or evaluating the combination of both in PCOS.ResultsEight clinical trials involving 313 patients were examined in the review. The intervention dosage of metformin ranged from 1,000 to 2,000 mg/d and that of oral contraceptives was ethinylestradiol 35 µg and cyproterone acetate 2 mg. Lower body mass index was observed with regimens including metformin, but increased body mass index was observed in monotherapy with oral contraceptives. Administration of metformin or oral contraceptives, especially as monotherapy, had a negative effect on lipid profiles. In addition, there are still uncertainties surrounding the effects of metformin or oral contraceptives in the management of insulin level, although they improved total testosterone and sex hormone-binding globulin levels. In the included studies, significant side effects due to metformin or oral contraceptives were not reported.ConclusionThe clinical trials suggest that metformin or oral contraceptives are at least patient convenient, efficacious, and safe for the treatment of PCOS. However, well-designed, prospective, long-term, large-scale, randomized clinical trials are necessary to elucidate the efficacy and safety of metformin, oral contraceptives, or both in the treatment of PCOS, and to elucidate their individual roles in the treatment of this condition.

Features of ovarian cancer in Lynch syndrome (Review).

Lynch syndrome is a hereditary ovarian cancer with a prevalence of 0.9-2.7%. Lynch syndrome accounts for 10-15% of hereditary ovarian cancers, while hereditary breast and ovarian cancer syndrome accounts for 65-75% of these cancers. The lifetime risk for ovarian cancer in families with Lynch syndrome is ~8%, which is lower than colorectal and endometrial cancers, and ovarian cancer is not listed in the Amsterdam Criteria II. More than half of sporadic ovarian cancers are diagnosed in stage III or IV, but ≥80% of ovarian cancers in Lynch syndrome are diagnosed in stage I or II. Ovarian cancers in Lynch syndrome mostly have non-serous histology and different properties from those of sporadic ovarian cancers. A screening method for ovarian cancers in Lynch syndrome has yet to be established and clinical studies of prophylactic administration of oral contraceptives are not available. However, molecular profiles at the genetic level indicate that ovarian cancer in Lynch syndrome has a more favorable prognosis than sporadic ovarian cancer. Inhibitors of the phosphatidylinositol 3-kinase/mammalian target of the rapamycin pathway and anti-epidermal growth factor antibodies may have efficacy for the disease. To the best of our knowledge, this is the first review focusing on ovarian cancer in Lynch syndrome.

Immunomodulatory effects by oral contraceptives in normal and cholestatic female rats: role of cytokines.

Oral contraceptives (OC) may cause intrahepatic cholestasis or increase a pre-established liver damage. OC effects on hepatic injury biochemical markers remain contradictory and the role of cytokines in those processes is fairly unknown. Two doses, simple or double, of the OC combination ethinylestradiol/norgestrel were administered during 14 or 28 days to normal and cholestatic female rats. Liver damage markers and the cytokines tumor necrosis factor-α (TNF-α), interleukin-10 (IL-10) and transforming growth factor-β (TGF-β) were determined in plasma and liver. OC caused ambiguous results on cholestasis indicators, even more in cholestatic rats. Necrosis rose during cholestasis while OC lowered it in normal rats. Fibrosis was induced by cholestasis but OC double dose or intake time diminished that. Cholestasis depleted glycogen while OC did not alter it. Double dose or time of administration of OC significantly elevated the lipid peroxidation. Cholestasis modified plasma and liver cytokines but OC remarkably altered them in normal and cholestatic animals. TNF-α as well as IL-10 were increased in both tissues by OC, such rise was higher in normal rats. TGF-β was augmented by OC and more in cholestatic rats receiving double dose. Thus, OC modified most liver injury markers in normal rats although more pronouncedly in cholestatic ones, as well as increased hepatic oxidative stress. Liver fibrosis was decreased and corroborated by histological analysis even when TGF-β is elevated by OC. OC strongly immunomodulate cytokines that mediate liver damage or worsen a prior hepatopathy; those processes are influenced by dose, administration time and OC formulation.

Inhibitory effect of oral contraceptives on CYP2C19 activity is not significant in carriers of the CYP2C19*17 allele

(1) The purpose of the present study was to examine whether cytochrome P450 2C19 (CYP2C19) in carriers of the CYP2C19*17 allele is inhibited in vivo by oral contraceptives (OC). (2) Retrospective CYP2C19 phenotyping according to omeprazole : 5-OH-omeprazole molar 3 h plasma metabolic ratios (MR) from a population (n = 222) genotyped as CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17 was analysed. Furthermore, 30 women genotyped as CYP2C19*1/*1 (n = 11), CYP2C19*1/*17 (n = 11) and CYP2C19*17/*17 (n = 8) were prospectively CYP2C19 phenotyped during the administration of OC and again after a minimum 5 days break from OC. (3) We found a significantly higher MR in the CYP2C19*1/*1 genotype group that took OC (n = 48) compared with women who did not take OC (n = 31; geometric mean 1.37 vs. 0.83, respectively; P < 0.05). However, in the CYP2C19*1/*17 genotype group, the geometric means of the MR in the 37 women taking OC and the 20 women not taking OC were 0.67 and 0.46, respectively (P > 0.05). In the CYP2C19*1/*1 panel of the prospective cross-over study, we found a significantly higher MR while women were taking the OC compared with the MR during the OC break (geometric mean 1.21 vs. 0.91, respectively; P = 0.0123). However, in the CYP2C19*1/*17 group, the geometric means of the MR with and without OC were 0.77 and 0.65, respectively, compared with 1.05 and 0.79, respectively, in the CYP2C19*17/*17 group (P = 0.20 and 0.17, respectively). (4) In conclusion, we have shown that OC intake inhibits CYP2C19 in homozygous carriers of the CYP2C19 wild type but that the inhibition is not significant in heterozygous and homozygous carriers of the CYP2C19*17 allele.

A case of empty follicle syndrome who conceived after aspiration of an endometrial cyst.

Empty follicle syndrome (EFS) has been defined as a condition where no oocytes can be retrieved for in vitro fertilization (IVF) even though ultrasound findings and estradiol (E2) levels suggest the presence of potential follicles. The EFS is a rare condition with an incidence of 0.5-7 % of women undergoing IVF treatments. Although there are many hypotheses as to the cause of EFS, including advanced ovarian age, drug-related problems, and dysfunctional folliculogenesis, its cause remains unknown. A 37-year-old woman with endometriosis and a 5-year history of primary infertility underwent IVF treatment for 4 cycles. No oocytes were retrieved in 2 cycles and no fertilized eggs were obtained in the other 2 cycles. We assumed that endometriosis adversely affected folliculogenesis and fertilization. Aspiration of an endometrial cyst in the right ovary and subsequent administration of oral contraceptives resulted in successful folliculogenesis and fertilization. Thereafter, she conceived and delivered a 2,662 g female infant at 38 weeks of gestation. Here, we report a case of EFS who conceived in the 5th IVF cycle after aspiration of an endometrial cyst. We assumed that endometriosis might have been involved in the dysfunction of folliculogenesis and EFS.

Recurrence of endometrioma after laparoscopic excision and its prevention by medical management

Laparoscopic excision is considered as the 'gold standard' treatment of ovarian endometrioma. However, a frustrating aspect is that disease can recur. While laparoscopic excision is known to improve fertility, recurrence can cause significant ovarian damage and adverse affects on fertility. It is therefore crucial to prevent recurrence in order to conserve 'improved' fertility. Recurrence rates for endometrioma are reported from 11 to 32% within 1-5 years after excision. The recurrence rate is higher in patients with advanced endometriosis at surgery and in younger patients. Previous medical treatment for endometriosis prior laparoscopy is a risk factor for recurrence. Pregnancy soon after surgery has a protective effect for recurrence. The accumulating evidence suggests that the administration of oral contraceptives (OC), levonorgestrel-releasing intrauterine system (LNG-IUS) and a combination of gonadotropin releasing hormone (GnRH) analogue and OC may also have therapeutic benefits. Collectively, we propose that women should be well informed about the risks of endometrioma recurrence. We recommend that women who wish pregnancy should try conception as soon as possible. Further, we strongly advise hormonal therapy for patients, who do not want to conceive immediately, and until pregnancy is desired.

Effect of a high-fructose diet on glucose tolerance, plasma lipid and hemorheological parameters during oral contraceptive administration in female rats

Oral contraceptive (OC) use and increased fructose feeding have been associated with altered cardiometabolic effects. The effect of increased dietary fructose during OC use on cardiometabolic parameters is unknown. We investigated the effects of a high-fructose diet on body weight gain, fasting blood glucose, glucose tolerance, plasma lipid and hemorheological parameters in female rats treated with a combination of OC steroids (norgestrel/ethinyl estradiol; NEE). Rats were given (p.o.) vehicle, high-dose NEE (10.0 μg norgestrel/1.0 μg ethinyl estradiol) or low-dose NEE (1.0 μg norgestrel/0.1 μg ethinyl estradiol) with or without high dietary fructose daily for 6 weeks. Results demonstrated that high-dose NEE but not low-dose NEE treatment led to significant increases in hematocrit, blood viscosity, and decreases in body weight gain, glucose tolerance, and plasma HDL-cholesterol level. Both NEE treatments resulted in significant increases in plasma viscosity and triglyceride. Increased dietary fructose without NEE treatment produced significant increases in fasting blood glucose, hematocrit, blood and plasma viscosities, while increased dietary fructose significantly potentiated the effects on blood and plasma viscosities observed during NEE treatment. Conversely, the effects of NEE treatment on body weight gain, glucose tolerance, plasma triglyceride and HDL-cholesterol were significantly attenuated. In conclusion, the results indicate that increase in dietary fructose may worsen abnormal blood rheology. The results also demonstrate that increased dietary fructose may not impact negatively on glucose and lipid metabolisms during OC use. The findings imply that fructose-enriched diet might be an important consideration during OC use regarding blood rheological properties.

Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial

BackgroundConsistent with its effect on gastric emptying, exenatide, an injectable treatment for type 2 diabetes, may slow the absorption rate of concomitantly administered oral drugs resulting in a decrease in maximum concentration (Cmax). This study evaluated the drug interaction potential of exenatide when administered adjunctively with oral contraceptives, given their potential concomitant use.MethodsThis trial evaluated the effect of exenatide co-administration on single- and multiple-dose pharmacokinetics of a combination oral contraceptive (ethinyl estradiol [EE] 30 μg, levonorgestrel [LV] 150 μg [Microgynon 30®]). Thirty-two healthy female subjects participated in an open-label, randomised, crossover trial with 3 treatment periods (oral contraceptive alone, 1 hour before exenatide, 30 minutes after exenatide). Subjects received a single dose of oral contraceptive on Day 8 of each period and QD doses on Days 10 through 28. During treatment periods of concomitant usage, exenatide was administered subcutaneously prior to morning and evening meals at 5 μg BID from Days 1 through 4 and at 10 μg BID from Days 5 through 22. Single- (Day 8) and multiple-dose (Day 22) pharmacokinetic profiles were assessed for each treatment period.ResultsExenatide did not alter the bioavailability nor decrease daily trough concentrations for either oral contraceptive component. No substantive changes in oral contraceptive pharmacokinetics occurred when oral contraceptive was administered 1 hour before exenatide. Single-dose oral contraceptive administration 30 minutes after exenatide resulted in mean (90% CI) Cmax reductions of 46% (42-51%) and 41% (35-47%) for EE and LV, respectively. Repeated daily oral contraceptive administration 30 minutes after exenatide resulted in Cmax reductions of 45% (40-50%) and 27% (21-33%) for EE and LV, respectively. Peak oral contraceptive concentrations were delayed approximately 3 to 4 hours. Mild-to-moderate nausea and vomiting were the most common adverse events observed during the trial.ConclusionsThe observed reduction in Cmax is likely of limited importance given the unaltered oral contraceptive bioavailability and trough concentrations; however, for oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before exenatide injection.Trial registrationClinicalTrials.gov: NCT00254800.

What is the Impact on Sexual Function of Laparoscopic Treatment and Subsequent Combined Oral Contraceptive Therapy in Women with Deep Infiltrating Endometriosis?

Deep infiltrating endometriosis (DIE) is a form of endometriosis in which the lesion penetrates for more than 5 mm under the peritoneal surface. It is a chronic disease which can impair women's sexual function. There is a growing body of evidence supporting combined surgical/medical treatment in the management of DIE. The aims of this article are to evaluate the impact of the laparoscopic full excision of endometriosis and postoperative combined oral contraceptives (COC) administration on sexual function in patients with DIE and to compare sexual function outcomes of women submitted to intestinal resection and nodule excision. It is a prospective cohort study in a tertiary care university hospital on 106 sexually active women, with histologically confirmed DIE, managed by laparoscopy and subsequent COC therapy for 6 months. Patients filled preoperatively and 6-month postoperatively a quality of sexual life questionnaire, the Sexual Health Outcomes in Women Questionnaire (SHOW-Q) and they ranked their symptom intensity using a 10-point visual analogue scale (VAS). Sexual function was measured through the SHOW-Q scores and pain symptoms through VAS scores. Intraoperative details, type of intervention and perioperative complications were noted. Six months after surgery and postoperative COC treatment, a significant improvement was observed in the SHOW-Q domains of pelvic problem interference, sexual satisfaction and desire (P<0.05). Laparoscopic management of DIE did not change significantly the orgasm area of the sexual functioning (P=0.7). No significant difference was found in SHOW-Q scores between patients submitted to intestinal resection and patients submitted to intestinal nodule excision (P>0.05). Sexual desire, satisfaction with sex and pelvic problem interference with intercourse are significantly improved after 6 months from laparoscopic excision of DIE combined with postoperative COC therapy. No difference in sexual outcomes was detected between patients submitted to intestinal resection and nodule excision.

Migraine in women: the role of hormones and their impact on vascular diseases.

Migraine is a predominantly female disorder. Menarche, menstruation, pregnancy, and menopause, and also the use of hormonal contraceptives and hormone replacement treatment may influence migraine occurrence. Migraine usually starts after menarche, occurs more frequently in the days just before or during menstruation, and ameliorates during pregnancy and menopause. Those variations are mediated by fluctuation of estrogen levels through their influence on cellular excitability or cerebral vasculature. Moreover, administration of exogenous hormones may cause worsening of migraine as may expose migrainous women to an increased risk of vascular disease. In fact, migraine with aura represents a risk factor for stroke, cardiac disease, and vascular mortality. Studies have shown that administration of combined oral contraceptives to migraineurs may further increase the risk for ischemic stroke. Consequently, in women suffering from migraine with aura caution should be deserved when prescribing combined oral contraceptives.Electronic supplementary materialThe online version of this article (doi:10.1007/s10194-012-0424-y) contains supplementary material, which is available to authorized users.

Unscheduled bleeding in continuous oral contraceptive pill a comparison of progestin dose

Continuous administration of oral contraceptives (OCs) is widely practiced to eliminate hormonal withdrawal bleeding. While the overall number of bleeding days is reduced; unscheduled, irregular bleeding increases which is the major reason for dissatisfaction. The objective of this study was to determine whether progestin dose influences bleeding patterns.

Risk of venous thromboembolism with drospirenone-containing oral contraceptives

The risk of venous thromboembolism (VTE) with drospirenone-containing oral contraceptives (OCs) is reviewed. Increasing attention and media have raised awareness and concern about whether drospirenone-containing OCs increase the risk of VTE. Two studies found that when compared with nonuse of OCs, use of drospirenone-containing OCs was associated with a fourfold to over sixfold increased risk of having a thrombotic event. One of these studies found an increased risk associated with short-term use of drospirenone-containing OCs; however, this study was limited by the small number of participants taking drospirenone despite the large number of study participants. The cohort study that found a higher rate of VTE among drospirenone users was only able to indicate an association between drospirenone use and VTE, not a cause-and-effect relationship. Three studies concluded that drospirenone-containing OCs did not appear to cause an increased risk of VTE. The hemostatic studies found no difference in the various variables assessed between drospirenone- and desogestrel-containing OCs or between cyclic and continuous administration of drospirenone-containing OCs. These results should be interpreted cautiously, as each study had limitations, such as not controlling for confounders (e.g., recent surgery, immobility, obesity), not providing p values to assess homogeneity between treatment groups, and not providing total numbers of participants or specific types of OCs. Patients who receive drospirenone-containing OCs should be educated regarding the signs and symptoms of VTE, along with an appropriate action plan. The majority of available data does not support the conclusion that drospirenone-containing OCs pose an increased risk of VTE compared with other OCs.

Effects of oral contraceptives on natriuretic peptide levels in women with hypothalamic amenorrhea: a pilot study

Natriuretic peptides, which are important regulators of salt handling and blood pressure, are 60%-75% higher in healthy young women than in men, consistent with a gender dimorphism. In this randomized, placebo-controlled study in women with functional hypothalamic amenorrhea, we show that administration of oral contraceptives (OC) increases natriuretic peptide levels and that end-of-study free T levels are inversely associated with amino-terminal pro-B-type natriuretic peptide levels, consistent with the hypothesis that natriuretic peptide levels may be mediated by differences in gonadal steroid concentrations-estrogens (E) or androgens.

Effect of raltegravir on estradiol and norgestimate plasma pharmacokinetics following oral contraceptive administration in healthy women

Oral contraceptives such as norgestimate-ethinyl estradiol (Ortho Tri-Cyclen®) are commonly prescribed in the HIV-infected patient population. A placebo-controlled, randomized, two-period crossover study in healthy HIV-seronegative subjects was conducted to assess the effect of raltegravir on the pharmacokinetics of the estrogen and progestin components of norgestimate-ethinyl estradiol [ethinyl estradiol (EE) and norelgestromin (NGMN), an active metabolite of norgestimate (NGT)]. In each of two periods, nineteen healthy women established on norgestimate-ethinyl estradiol contraception (21 days of active contraception; 7 days of placebo) received either 400 mg raltegravir or matching placebo twice daily on days 1-21. Pharmacokinetics were analysed on day 21 of each period. The geometric mean ratio (GMR) and 90% confidence interval (CI) for the EE component of norgestimate-ethinyl estradiol when co-administrated with raltegravir relative to EE alone was 0.98 (0.93-1.04) for the area under the concentration-time curve from 0 to 24 h (AUC(0-24 h) ) and 1.06 (0.98-1.14) for the maximum concentration of drug in the plasma (C(max) ); the GMR (90% CI) for the NGMN component of norgestimate-ethinyl estradiol when co-administered with raltegravir relative to NGMN alone was 1.14 (1.08-1.21) for AUC(0-24 h) and 1.29 (1.23-1.37) for C(max) . There were no discontinuations due to a study drug-related adverse experience, nor any serious clinical or laboratory adverse experience. Raltegravir has no clinically important effect on EE or NGMN pharmacokinetics. Co-administration of raltegravir and an oral contraceptive containing EE and NGT was generally well tolerated; no dose adjustment is required for oral contraceptives containing EE and NGT when co-administered with raltegravir.