On the relation between oral contraceptive use and self-control.

In two studies we examined the relation between oral contraceptive (OC) use and self-reported levels of self-control in undergraduate women using OCs (Study 1: OC group N = 399, Study 2: OC group N = 288) and naturally cycling women not using any form of hormonal contraceptives (Study 1: Non-OC group N = 964, Study 2: Non-OC group N = 997). We assessed the self-overriding aspect of self-control using the Brief Self-Control Scale (BSCS) and strategies for self-regulation using the Regulatory Mode Scale (RMS), which separately measures the tendency to assess one's progress towards a goal (assessment), and the tendency to engage in activities that move one towards an end goal (locomotion). In Study 1, we found no significant differences between OC and non-OC groups in their levels of self-overriding or self-regulatory assessment. However, we found that those in the OC group reported significantly greater levels of self-regulatory locomotion compared to those in the non-OC group, even after controlling for depression symptoms and the semester of data collection. The findings from Study 2 replicated the findings from Study 1 in a different sample of participants, with the exception that OC use was also related to higher levels of assessment in Study 2. These results indicate that OC use is related to increases in self-regulatory actions in service of goal pursuit and perhaps the tendency to evaluate progress towards goals.

Differential changes in appetite hormones post-prandially based on menstrual cycle phase and oral contraceptive use: A preliminary study.

This was a preliminary study that examined whether appetite regulation is altered during the menstrual cycle or with oral contraceptives. Ten naturally cycling females (NON-USERS) and nine tri-phasic oral contraceptive using females (USERS) completed experimental sessions during each menstrual phase (follicular phase: FP; ovulatory phase: OP; luteal phase: LP). Appetite perceptions and blood samples were obtained fasted, 30, 60, and 90 min post-prandial to measure acylated ghrelin, active glucagon-like peptide-1 (GLP-1), and total peptide tyrosine tyrosine (PYY). Changes were considered important if p < 0.100 and the effect size was ≥medium. There appeared to be a three-way (group x phase x time) interaction for acylated ghrelin where concentrations appeared to be greater in USERS versus NON-USERS during the OP 90-min post-prandial and during the LP fasted, and 90-min post-prandial. In USERS, ghrelin appeared to be greater 90-min post-prandial in the OP versus the FP with no other apparent differences between phases. There were no apparent differences between phases in NON-USERS. There appeared to be a three-way interaction for PYY where concentrations appeared to be greater in USERS during the FP 60-min post-prandial and during the OP 30-min post-prandial. In USERS PYY appeared to be greater 60-min post-prandial during the OP versus the LP with no other apparent differences. There were no apparent differences between phases in NON-USERS. There appeared to be no effect of group or phase on GLP-1, or appetite perceptions. These data demonstrate small effects of menstrual cycle phase and oral contraceptive use on the acylated ghrelin and total PYY response to a standardized meal, with no effects on active GLP-1 or perceived appetite, though more work with a large sample size is necessary.

Abortion by request in advanced maternal age: What changes in contraception? / Interrupción voluntaria del embarazo en edad materna avanzada: ¿qué cambia en la anticoncepción?

Overview and aim: Pregnancy at an advanced maternal age has become a reality. The acceptance rate of an unwanted pregnancy in this age group is lower, resulting in a higher proportion of pregnancy interruptions. This study aims to characterize abortion by request (AR) in advanced maternal age. Methods: Descriptive study of AR requested by women aged 40 years old or older, over a period of six years, in an Obstetrics service of a Portuguese tertiary hospital. Descriptive data analysis was performed using SPSS® version 26. Results: 194 women were included in the study (n=194), with a median age of 42 years, most of them Portuguese (94.3%) and with no history of performing AR (75.2%). The contraceptive methods used prior to AR were used oral contraception (47.0%) and barrier contraception (39.1%). Medical abortion was performed in the entire sample, with a success rate of 96.9%. After AR, intrauterine contraception (44.3%), oral contraception (22.7%) and the vaginal ring (7.2%) were the preferred contraceptive methods. Discussion/Conclusions: Changes in women's health and contraceptive needs motivate new approaches and contraceptive strategies. After AR, a significant percentage of woman chose long-term and non-user-dependent methods. Particularly in women aged 40 or over, these methods, in addition to their highly effective and safe contraceptive role, may bring additional non-contraceptive benefits, namely the therapeutic effect in abnormal uterine bleeding.(AU)

Introducción y objetivoEl embarazo a una edad materna avanzada se ha convertido en una realidad. La tasa de aceptación de un embarazo no deseado en esta edad es menor, lo que se traduce en una mayor proporción de interrupciones del embarazo. Este estudio tiene como objetivo caracterizar la interrupción voluntaria del embarazo (IVE) en edad materna avanzada.MétodosEstudio descriptivo de las IVE solicitadas por mujeres de 40 años o más, durante un período de 6 años, en un servicio de obstetricia de un hospital terciario portugués. El análisis descriptivo de los datos se realizó con SPSS® versión 26.ResultadosSe incluyeron en el estudio 194 mujeres (n=194), con una mediana de edad de 42 años, la mayoría portuguesas (94,3%) y sin antecedentes de realización de IVE (75,2%). Los métodos anticonceptivos utilizados antes de la IVE fueron la anticoncepción oral (47,0%) y la anticoncepción de barrera (39,1%). El aborto médico se realizó en toda la muestra, con una tasa de éxito del 96,9%. Después de la IVE, la anticoncepción intrauterina (44,3%), la anticoncepción oral (22,7%) y el anillo vaginal (7,2%) fueron los métodos anticonceptivos preferidos.Discusión/conclusionesLos cambios en la salud de las mujeres y las necesidades anticonceptivas motivan nuevos enfoques y estrategias anticonceptivas. Después de la IVE, un porcentaje significativo de mujeres eligió métodos a largo plazo y no dependientes de la usuaria. Particularmente en mujeres de 40 años o más, estos métodos, además de su función anticonceptiva altamente efectiva y segura, pueden traer beneficios adicionales no anticonceptivos, por ejemplo, el efecto terapéutico en el sangrado uterino anormal.(AU)

Evaluation of consumer self-selection of a proposed over-the-counter, progestin-only daily oral contraceptive.

OBJECTIVES: In an effort to switch a norgestrel 0.075 mg progestin-only pill (Opill) from prescription to over-the-counter, we conducted this study to assess whether consumers can use the drug facts label alone to guide appropriate self-selection. STUDY DESIGN: Two studies assessed self-selection: (1) an all-comers, actual-use study evaluating self-selection before purchasing and using norgestrel 0.075 mg and (2) the Targeted Breast Cancer Self-Selection Study evaluating theoretical self-selection among participants with a history of breast cancer. RESULTS: In the actual-use study, based on the label, 1670/1772 participants (94%) were appropriate for use of norgestrel 0.075 mg; 102 (6%) were not appropriate. Of the 102, 66 (65%) correctly did not select and 36 (35%) responded it was okay for them to use norgestrel 0.075 mg. Of the 36 participants who incorrectly self-selected, one had a history of breast cancer and thus might have been adversely affected had they taken norgestrel 0.075 mg. In the Targeted Breast Cancer Self-Selection Study (N = 206), 97% of participants correctly stated norgestrel 0.075 mg was not appropriate for them. CONCLUSIONS: The proposed over-the-counter label enables 98% of potential users to self-select norgestrel 0.075 mg appropriately. Only 2% of potential purchasers may have bought and started to use norgestrel 0.075 mg inappropriately. For two-thirds of these, the potential benefits of their use of the method outweighed any theoretical risks. Adverse clinical consequences of norgestrel 0.075 mg use are unlikely even in those rare cases when the drug facts label was not followed. IMPLICATIONS: The balance of the risk of inappropriate selection to the benefit of taking an over-the-counter progestin-only pill appears to be very much in favor of an overall benefit in terms of unintended pregnancy prevention.

Evaluation of adherence to a daily progestin-only pill in a simulated over-the-counter setting.

OBJECTIVE: The Adherence with Continuous Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study assessed whether consumers can adhere to the regimen for a progestin-only pill (norgestrel 0.075 mg) in an over-the-counter (OTC) setting. STUDY DESIGN: An actual use study in a simulated OTC environment assessed adherence to directions to take norgestrel 0.075 mg every day at the same time in 883 participants for up to 24 weeks. RESULTS: Eighty-five percent (747/883) of participants reported ≥85% adherence to taking norgestrel 0.075 mg every day and reported taking their dose within three hours of their scheduled dosing time on 96% of days. When accounting for use of a condom for 48 hours if a pill was missed, participants reported correctly following the label's directed use for 97% of doses overall, with 95% of participants following label directions for ≥85% of doses. The main limitations were related to finding a balance between intensely collecting data to ensure accurate assessment of adherence and leaving users to behave as they would in a real OTC situation without healthcare practitioner intervention. We observed that some participants reported taking more doses than they could have based on the supply of medication given to them. To fully examine the situation, and the impact on the conclusions, additional post hoc sensitivity analyses were performed, and showed remarkably consistent results. CONCLUSIONS: Consumers were highly adherent to taking norgestrel 0.075 mg when using only the information provided by the proposed OTC label. IMPLICATIONS: Adherence to a daily oral contraceptive pill was high when obtained OTC. This suggests that effectiveness of an OTC pill is likely to be like that of a prescribed pill and easier access to this effective contraceptive should allow more opportunity to prevent pregnancy.

Reproductive factors and risk of lung cancer among 300,000 Chinese female never-smokers: evidence from the China Kadoorie Biobank study.

BACKGROUND: Lung cancer is the leading cause of cancer mortality among Chinese females despite the low smoking prevalence among this population. This study assessed the roles of reproductive factors in lung cancer development among Chinese female never-smokers. METHODS: The prospective China Kadoorie Biobank (CKB) recruited over 0.5 million Chinese adults (0.3 million females) from 10 geographical areas in China in 2004-2008 when information on socio-demographic/lifestyle/environmental factors, physical measurements, medical history, and reproductive history collected through interviewer-administered questionnaires. Cox proportional hazard regression was used to estimate adjusted hazard ratios (HRs) of lung cancer by reproductive factors. Subgroup analyses by menopausal status, birth year, and geographical region were performed. RESULTS: During a median follow-up of 11 years, 2,284 incident lung cancers occurred among 282,558 female never-smokers. Ever oral contraceptive use was associated with a higher risk of lung cancer (HR = 1.16, 95% CI: 1.02-1.33) with a significant increasing trend associated with longer duration of use (p-trend = 0.03). Longer average breastfeeding duration per child was associated with a decreased risk (0.86, 0.78-0.95) for > 12 months compared with those who breastfed for 7-12 months. No statistically significant association was detected between other reproductive factors and lung cancer risk. CONCLUSION: Oral contraceptive use was associated with an increased risk of lung cancer in Chinese female never-smokers. Further studies are needed to assess lung cancer risk related to different types of oral contraceptives in similar populations.

Reproductive Planning: Long-Acting Reversible Contraceptives and Emergency Contraception.

Long-acting reversible contraceptives (LARCs) include progestin and copper intrauterine devices (IUDs) and progestin subdermal implants. LARCs may be the preferred for individuals who want a method that is highly effective and can last for several years, or for whom estrogen is contraindicated. LARCs should be offered using a shared decision-making approach, keeping in mind that historically these methods have been used coercively to control the reproductive choices of marginalized or disabled people. To ensure safe prescribing and reduce barriers to receiving LARCs, family physicians should be familiar with two evidence-based national contraceptive guidelines: the U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) and the U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR). Information about insertion, removal, potential complications, and expected adverse effects should be included when counseling patients about LARC options. Both types of LARC IUDs can safely be used for emergency contraception if inserted within 5 days of unprotected intercourse. Several oral emergency contraception drug options also are available.

A systematic review of the association between modifiable lifestyle factors and circulating anti-Müllerian hormone.

BACKGROUND: Levels of anti-Müllerian hormone (AMH) are known to be associated with lifestyle determinants such as smoking and oral contraception (OC) use. When measuring AMH in clinical practice, it is essential to know which factors may influence circulating levels or ovarian reserve in general. OBJECTIVE AND RATIONALE: To date, there is no systematic review or summarizing consensus of the nature and magnitude of the relation between AMH and modifiable lifestyle factors. The purpose of this review was to systematically assess the evidence on association of lifestyle behaviors with circulating AMH levels. SEARCH METHODS: We performed a pre-registered systematic review of publications in Embase and PubMed on the lifestyle factors BMI, smoking, OC use, alcohol consumption, caffeine consumption, physical activity, and waist-hip ratio (WHR) in relation to circulating AMH levels up to 1 November 2023. The search strategy included terms such as 'Anti-Mullerian hormone', 'lifestyle', and 'women'. Studies were considered eligible if the association between at least one of the lifestyle factors of interest and AMH was assessed in adult women. The quality of included studies was assessed using the Study Quality Assessment Tools of the National Heart, Lung, and Blood Institute. The results were presented as ranges of the most frequently used association measure for studies that found a significant association in the same direction. OUTCOMES: A total of 15 072 records were identified, of which 65 studies were eligible for inclusion, and 66.2% of the studies used a cross-sectional design. The majority of studies investigating BMI, smoking, OC use, and physical activity reported significant inverse associations with AMH levels. For WHR, alcohol, and caffeine use, the majority of studies did not find an association with AMH. For all determinants, the effect measures of the reported associations were heterogeneous. The mean difference in AMH levels per unit increase in BMI ranged from -0.015 to -0.2 ng/ml in studies that found a significant inverse association. The mean difference in AMH levels for current smokers versus non-smokers ranged from -0.4 to -1.1 ng/ml, and -4% to -44%, respectively. For current OC use, results included a range in relative mean differences in AMH levels of -17% to -31.1%, in addition to a decrease of 11 age-standardized percentiles, and an average decrease of 1.97 ng/ml after 9 weeks of OC use. Exercise interventions led to a decrease in AMH levels of 2.8 pmol/l to 13.2 pmol/l after 12 weeks in women with polycystic ovary syndrome or a sedentary lifestyle. WIDER IMPLICATIONS: Lifestyle factors are associated with differences in AMH levels and thus should be taken into account when interpreting individual AMH measurements. Furthermore, AMH levels can be influenced by the alteration of lifestyle behaviors. While this can be a helpful tool for clinical and lifestyle counseling, the nature of the relation between the observed differences in AMH and the true ovarian reserve remains to be assessed. REGISTRATION NUMBER: PROSPERO registration ID: CRD42022322575.

Norgestrel (Opill) Is the First Over-the-Counter Oral Contraceptive Pill Approved in the United States.

Just less than half of the pregnancies in the United States are unintended. Unintended pregnancy rates are greatest among women younger than 24 years, women of color, and those who have incomes less than 200% of the federal poverty level. Additionally, options to terminate a pregnancy are restricted or limited in some states. In July 2023, the U.S. Food and Drug Administration approved norgestrel (Opill) as the first over-the-counter oral contraceptive pill available in the United States. Norgestrel is indicated specifically for the prevention of pregnancy, contains only progesterone, and is indicated for daily oral use. This article provides an overview of over-the-counter norgestrel, including administration, adverse effects, contraindications, and practice implications for women's health nurses.

Influence of Second-Generation Oral Contraceptives on Muscle Recovery after Repeated Resistance Exercise in Trained Females.

PURPOSE: Oral contraceptives (OCs) are commonly used by female athletes, but their effects on skeletal muscle are still poorly understood. We investigated if physically trained females using second-generation OCs differed from nonusers of OCs in the recovery of muscle function and muscle damage markers after repeated resistance exercise sessions. METHODS: We recruited 20 trained second-generation OC users and 20 trained nonusers to perform three strenuous resistance exercise sessions. Before, and 3, 24, and 48 h after exercise, blood samples were collected, and participants were evaluated for muscle soreness, maximal isometric and isokinetic muscle strength, vertical jump height, Wingate power performance, leg press strength, and intermittent recovery capacity (yo-yo test). All participants were provided with an energy-macronutrient-balanced diet during the experimental period. RESULTS: After resistance exercise, maximal isometric and isokinetic muscle strength, rate of force development, vertical jump height, and Wingate peak and average power were reduced, whereas markers of muscle damage were increased in both groups (P < 0.05). OC users experienced a greater reduction in isokinetic strength 3, 24, and 48 h after exercise compared with nonusers of OCs (interaction: P < 0.05). No other interactions were observed. CONCLUSIONS: We demonstrate that measures of muscle strength recovery after three strenuous resistance exercise sessions are comparable between trained females using second-generation OCs and nonusers of OCs. However, group differences were observed for isolated dynamic (isokinetic) muscle strength, suggesting a marginal benefit of not using OCs when accelerated recovery is needed.

Comparison of resumption of ovulation after cessation of oral contraceptives and medroxyprogesterone acetate in women with polycystic ovary syndrome.

OBJECTIVE: Both oral contraceptive pills (OCPs) and cyclic medroxyprogesterone acetate (MPA) are widely used to control menstrual abnormalities in women with polycystic ovary syndrome (PCOS). We aimed to evaluate the chance of ovulation resumption after cessation of OCPs and MPA in women with PCOS. METHODS: A retrospective study was conducted of women with PCOS who were treated with OCPs or cyclic MPA from September 2015 to March 2019. After cessation of medication, ovulation was assessed using basal body temperature and/or measurement of serum progesterone. The odds ratio for ovulation resumption was assessed with multivariable logistic regression. Additionally, doubly robust analysis was performed with inverse-probability-weighted analysis and regression adjustment based on the covariate balancing propensity score to adjust for the effect of covariates on the treatment assignment. RESULTS: Among 272 women with PCOS, 136 were prescribed OCPs and 136 were prescribed cyclic MPA. Ovulation resumed in 18.4% of women (n = 25) after cessation of MPA and in 24.3% of women (n = 33) after cessation of OCPs. The odds of ovulation resumption in MPA users were comparable with those in OCP users (adjusted odds ratio (aOR) 1.00, 95% confidence interval (CI) 0.89-1.12). After multiple imputation due to missing values, the results did not change substantially (aOR 0.99, 95% CI 0.89-1.10). CONCLUSIONS: Among women with PCOS, MPA users have a similar chance of ovulation resumption as OCP users after cessation of medication. Cyclic MPA can be a good alternative to OCPs in women for whom OCPs are contraindicated or who decline to take OCPs.

Prevalence of human papillomavirus infection and associated factors among women attending cervical cancer screening in setting of Addis Ababa, Ethiopia.

Human papillomaviruses (HPVs) are circular, nonenveloped small double-stranded DNA viruses that infect stratified epithelium and can cause a number of life-threatening diseases. HPV is the central risk factor for developing cervical cancer and is estimated that approximately 98% of this disease is associated with oncogenic types of HPV. HPV infection leads to an estimated 266,000 cervical cancer deaths annually. Therefore, the objective of this study was to determine the prevalence of HPV infection and risk factors associated with cervical lesion among women attending the cervical cancer screening clinic at the Ethiopian Family Guidance Association, Addis Ababa. A cross-sectional study was conducted to determine the prevalence of HPV infection. Data were collected using a questionnaire and samples leftover from cervical screening were taken. The leftover swab was air dried and DNA was extracted and amplified by using a PCR. A total of 247 women were included in the study. The prevalence of HPV was 9.72% among the population studied. Of all participants, 27.13% were positive for cervical intraepithelial neoplasia-1 (CIN1). CIN1 positivity was found in half of HPV positive women. Among HPV positive women, half of them had started sexual intercourse at ages 12-17 years and 41.66% were women who gave birth at ages 12-17 years. The high prevalence of HPV and the CIN1 positive group were ages 36-57 and women with multiple sexual partners. The other groups with the highest CIN1 positive were 22.39% grade (9-12) and 20.9% primary (1-8) and uneducated women. Among HPV positive women, 83.33% had an abortion history and 80% miscarried in the first trimester. Among the CIN1 positives, 53.73% had more than two sexual partners. Among HPV positive women, half of them were users of contraception methods. In conclusion, the highest prevalence of HPV is among women who began sexual intercourse earlier and who gave birth at 12-17 years of age, have an abortion history, with MSP and oral contraceptive methods users. In addition to HPV, early pregnancy and sexual intercourse at 12-17 years of age, abortion, MSP, and oral hormonal contraceptives are factors in cervical cancer. Finally, most women do not have enough knowledge and awareness about cervical cancer and the risk factor.

Knowledge of non-contraceptive benefits of and willingness to consider taking oral contraceptive pills among a low-risk female population: a cross-sectional study.

BACKGROUND: In addition to its widely-appreciated contraceptive applications, the oral contraceptive pill (OCP) conveys both oncological and non-oncological benefits. Oncological benefits include a decreased risk of endometrial, ovarian, and colorectal cancer. Non-oncological benefits include reducing androgenic effects and alleviating menstruation-related problems. This study aimed to ascertain knowledge levels of non-contraceptive benefits and risks of OCP use among participants without contraindications to OCPs. This study also assessed factors associated with participants being more likely to consider taking OCPs. METHODS: 263 women aged 21 to 40 years old with no contraindications for OCP usage participated in this study. An anonymous questionnaire collected sociodemographic information and assessed participants' knowledge of the non-contraceptive benefits and risks associated with OCP use. Multivariate linear regression was used to assess factors associated with knowledge levels. Multivariate logistic regression was used to investigate factors associated with being more likely to consider taking OCPs among women who did not presently take them. RESULTS: Multivariate logistic regression revealed that participants who were more knowledgeable overall about the non-contraceptive benefits of OCPs were more likely to consider taking OCPs (coefficient = 0.184, p-value = 0.00). Knowledge of both oncological and non-oncological benefits of OCP use was relatively poor, especially among older women. Current OCP users were found to be more knowledgeable about their benefits. CONCLUSIONS: As women with greater knowledge of non-contraceptive benefits of OCPs are more likely to consider taking them, knowledge gaps regarding OCPs should be filled, so that more women may reap the non-contraceptive benefits of OCPs.

A sample of women with a low risk profile for oral contraceptive pills in Singapore demonstrated poor overall knowledge of their non-contraceptive benefits. Greater knowledge of the non-contraceptive benefits of oral contraceptive pills was associated with a greater willingness to consider taking oral contraceptive pills.

Midostaurin drug interaction profile: a comprehensive assessment of CYP3A, CYP2B6, and CYP2C8 drug substrates, and oral contraceptives in healthy participants.

PURPOSE: Midostaurin, approved for treating FLT-3-mutated acute myeloid leukemia and advanced systemic mastocytosis, is metabolized by cytochrome P450 (CYP) 3A4 to two major metabolites, and may inhibit and/or induce CYP3A, CYP2B6, and CYP2C8. Two studies investigated the impact of midostaurin on CYP substrate drugs and oral contraceptives in healthy participants. METHODS: Using sentinel dosing for participants' safety, the effects of midostaurin at steady state following 25-day (Study 1) or 24-day (Study 2) dosing with 50 mg twice daily were evaluated on CYP substrates, midazolam (CYP3A4), bupropion (CYP2B6), and pioglitazone (CYP2C8) in Study 1; and monophasic oral contraceptives (containing ethinylestradiol [EES] and levonorgestrel [LVG]) in Study 2. RESULTS: In Study 1, midostaurin resulted in a 10% increase in midazolam peak plasma concentrations (Cmax), and 3-4% decrease in total exposures (AUC). Bupropion showed a 55% decrease in Cmax and 48-49% decrease in AUCs. Pioglitazone showed a 10% decrease in Cmax and 6% decrease in AUC. In Study 2, midostaurin resulted in a 26% increase in Cmax and 7-10% increase in AUC of EES; and a 19% increase in Cmax and 29-42% increase in AUC of LVG. Midostaurin 50 mg twice daily for 28 days ensured that steady-state concentrations of midostaurin and the active metabolites were achieved by the time of CYP substrate drugs or oral contraceptive dosing. No safety concerns were reported. CONCLUSION: Midostaurin neither inhibits nor induces CYP3A4 and CYP2C8, and weakly induces CYP2B6. Midostaurin at steady state has no clinically relevant PK interaction on hormonal contraceptives. All treatments were well tolerated.

A phase I/II study evaluating the pharmacokinetics, pharmacodynamics, and safety of drospirenone as an oral contraceptive in Japanese women.

AIM: Drospirenone (DRSP) is a synthetic progestogen approved as a progestin-only pill for contraception in both the United States and Europe. Herein, we conducted a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, and safety of DRSP in Japanese women. METHODS: Single and multiple doses of 4 mg of DRSP were orally administered to healthy premenopausal Japanese women. In the multiple-dose period, 4 mg of DRSP was administered once daily for 24 days. Pharmacokinetics, hormone levels, and adverse events (AEs) were investigated. RESULTS: Twelve Japanese women participated in this study. The single- and multiple-dose pharmacokinetics of DRSP was similar to that reported in previous studies in Caucasians. In the multiple-dose period, no subject displayed a progesterone level of more than 5.03 ng/mL. AEs were observed in 11 (91.7%) subjects. The most common AE was genital hemorrhage, which was observed in six (50.0%) subjects, followed by diarrhea and acne in four (33.3%) subjects each. All AEs resolved or improved at the end of the study, and complete recovery was confirmed in all subjects at follow-up. CONCLUSIONS: The pharmacokinetics of DRSP in Japanese women was similar to that of previous studies performed in Caucasian women. Repeated administration of DRSP maintained low plasma progesterone levels indicating effective inhibition of ovulation. No notable safety concerns were observed. In this phase I/II study, DRSP had no obvious pharmacokinetic, pharmacodynamic, or safety issues to consider in Japanese women.

Effects of In-Exercise Carbohydrate Supplementation on Prolonged High-Intensity Exercise Performance in Oral Contraceptive Users.

PURPOSE: To examine the impact of oral contraceptive (OC) phases on performance, physiological, and subjective responses to prolonged, intensive exercise when carbohydrate (CHO) stores are reduced. METHODS: Ten well-trained female cyclists using monophasic OC completed 4 identical trials (>150 min) under conditions of in-trial 60-g·h-1 CHO supplementation (CHO+) or placebo (CHO-) during the sugar- (SUG) and active-pill (ACT) phases of their OC cycle. Each trial comprised two 400-kcal time trials (TT) separated by 1 hour of submaximal cycling at first ventilatory threshold. RESULTS: Change in completion time from TT1 to TT2 was minimized in CHO+ compared with CHO- (4.06 [2.55] vs 6.08 [5.33] min; P = .019, effect size = -0.36). An interaction effect of OC and CHO was observed for time to complete TT (P = .006), mean TT power (P = .002), mean TT heart rate (P = .002), and posttrial emotional balance (P = .020) and negative emotional state (P = .033). In ACT, mean TT power and heart rate were higher in CHO+ when compared with CHO-, resulting in faster TTs in CHO+ and improved posttrial emotional well-being. When CHO was not supplemented, TT power and heart rate were higher in SUG when compared with ACT, resulting in faster TTs in SUG and improved posttrial emotional balance. CONCLUSION: CHO depletion during ACT negatively influenced TT performance and emotional well-being when compared with SUG. Irrespective of OC pill phase, CHO supplementation should be prioritized to sustain performance and improve postexercise recovery-stress balance.