Disparities in utilisation of combined oral contraceptives in Aotearoa New Zealand: A cross-sectional whole-of-population study.

AIMS: The combined oral contraceptive (COC) is the most commonly used hormonal contraceptive in Aotearoa New Zealand (Aotearoa/NZ). Currently there is limited data available on who uses COC in Aotearoa/NZ. The aims were to (i) define the population of reproductive-aged females in Aotearoa/NZ in 2018 and identify the rate of COC use among this group and (ii) describe the sociodemographic and geographic characteristics of the population of COC users compared to the general population of reproductive-aged females in 2018. METHODS: This whole-of-population cross-sectional study used the Integrated Data Infrastructure, a large research database managed by Statistics New Zealand. Females aged 16-50 years with complete sociodemographic and geographic information in 2018 from Aotearoa/NZ's estimated resident population were included. COC dispensing records to this cohort were identified from the national Pharmaceutical Collection. This paper reports descriptive counts of COC use and employs generalised linear regression with a binomial distribution and a log link to estimate adjusted risk ratios (aRR) of COC use for key sociodemographic and geographic subgroups. RESULTS: Of 1 113 750 individuals in the study, 159 789 (14.3%) were dispensed as COC in 2018. European/other individuals were most likely to use COC (aRR: 2.72, 2.67-2.78), and Pacific Peoples were least likely (aRR: 0.56, 0.55-0.58) to use COC. Individuals residing in the most deprived quintile had less COC use than individuals in the least deprived quintile (aRR: 0.73, 0.72-0.74). CONCLUSION: Our study is able to highlight significant disparities in use by ethnicity, area-level deprivation, and geographic factors.

Cost-effectiveness Analysis of Dienogest Compared with Combined Oral Contraceptives after Surgery for Endometriosis.

STUDY OBJECTIVE: To assess the cost-effectiveness of different strategies, including the dienogest (DNG) and combined oral contraceptives (COC) therapy, for the prevention of endometriosis recurrence after surgery. DESIGN: A decision tree model was created. The analysis was based on data from a healthcare provider in China. Model inputs were derived from published data. The end points included incremental cost effectiveness ratio, net monetary benefit (NMB), and incremental NMB associated with prevention of recurrence. The uncertainty was assessed through one way and probabilistic sensitivity analysis. The Consolidated Health Economic Evaluation Reporting Standards 2022 checklist was used to assess quality of the reporting. SETTING: China healthcare system. PATIENTS: Individuals undergoing laparoscopic surgery for endometriosis. INTERVENTIONS: DNG vs COC. MEASUREMENTS AND MAIN RESULTS: The base case analysis showed that hormone supression via DNG resulted in 0.7493 quality-adjusted life years (QALYs) at a cost of $1625.49 compared with COC, which resulted in 0.7346 QALYs at a cost of $343.61. The incremental cost effectiveness ratio was $87 679.89 per additional QALY gained and the DNG treatment was associated with an incremental NMB of -$731.39. Probabilistic sensitivity analysis indicated that DNG is not cost-effective in most cases at a threshold consistent with World Health Organisation recommendations of $37 653/QALY. CONCLUSION: The result of our present analysis suggests that the DNG might not be cost-effective for the prevention of endometriosis recurrence after surgery in China.

Assessment of Quality of Life, Sexual Quality of Life, and Pain Symptoms in Deep Infiltrating Endometriosis Patients With or Without Associated Adenomyosis and the Influence of a Flexible Extended Combined Oral Contraceptive Regimen: Results of a Prospective, Observational Study.

BACKGROUND: The quality of life of women with deep infiltrating endometriosis (DIE) is impaired and may improve with combined oral contraceptives (COCs). AIM: To compare the overall and sexual quality of life of patients diagnosed with DIE with or without associated adenomyosis (AD) with that of healthy controls and determine the influence of a COC containing 2 mg dienogest/30 µg ethinyl estradiol on these aspects. METHODS: We enrolled 42 women diagnosed with DIE; 31 diagnosed with DIE + AD by transvaginal ultrasound, and 39 non-AD/DIE controls. All patients were interviewed regarding pain symptoms (dysmenorrhea, dyspareunia, dyschezia, and dysuria), heavy menstrual bleeding using the Pictorial Blood Loss Assessment Chart, quality of life using the Short Form-36 questionnaire (SF-36), and sexual quality of life using the Sexual Quality of Life-Female questionnaire (SQOL-F) and the Brief Profile of Female Sexual Function (B-PFSF) before starting COCs and after 12 months of treatment. OUTCOMES: There was significant improvement in overall and sexual quality of life after treatment in DIE and DIE + AD patients. RESULTS: Non-AD/DIE controls showed significantly higher scores in the B-PFSF, the SQOL-F and the SF-36 questionnaires (P < .05) at baseline versus the other groups. DIE + AD patients showed poorer quality of sexual life and greater intensity in pain symptoms compared with DIE patients. After 12 months of treatment, there was a significant improvement in overall and sexual quality of life in the DIE and DIE + AD groups, with improvement in sexual quality of life being slightly greater in DIE + AD patients compared with DIE patients. Pain symptoms also decreased in both groups. CLINICAL IMPLICATIONS: Patients with DIE + AD showed greater impairment in overall and sexual quality of life compared with patients with isolated DIE which seems to improve with a COC containing 2 mg dienogest/30 µg ethinyl estradiol. STRENGTHS & LIMITATIONS: Strengths include the long-term follow up, assessment of the impact of two associated conditions, and administration of the same COC in all patients. Limitations include the relatively small sample size, and the fact that we did not assess the effectiveness of a flexible extended COC regimen containing 2 mg dienogest/30 µg ethinyl estradiol since the groups were different at baseline. CONCLUSION: Patients diagnosed with DIE with or without AD have a decreased quality of life which may improve with a COC containing 2 mg dienogest/30 µg ethinyl estradiol. Further research is needed to confirm our results. Alcalde AM, Martínez-Zamora MÁ, Gracia M, et al. Assessment of Quality of Life, Sexual Quality of Life, and Pain Symptoms in Deep Infiltrating Endometriosis Patients With or Without Associated Adenomyosis and the Influence of a Flexible Extended Combined Oral Contraceptive Regimen: Results of a Prospective, Observational Study. J Sex Med 2022;19:311-318.

A cohort study of the service-users of online contraception.

BACKGROUND: In January 2017, the first free service providing oral contraceptive pills (OCPs) ordered online and posted home became available in the London boroughs of Lambeth and Southwark - ethnically and socioeconomically diverse areas with high rates of unplanned pregnancy. There are concerns that online services can increase health inequalities; therefore, we aimed to describe service-users according to age, ethnicity and Index of Multiple Deprivation (IMD) quintile of area of residence and to examine the association of these with repeated use. METHODS: We analysed routinely collected data from January 2017 to April 2018 and described service-users using available sociodemographic factors and information on patterns of use. Logistic regression analysis examined factors associated with repeat ordering of OCPs. RESULTS: The service was accessed by 726 individuals; most aged between 20 and 29 years (72.5%); self-identified as being of white ethnic group (58.8%); and residents of the first and second most deprived IMD quintiles (79.2%). Compared with those of white ethnic group, those of black ethnic group were significantly less likely to make repeat orders (adjusted OR 0.53, 95% CI 0.31 to 0.89; p=0.001), as were those of Asian and mixed ethnic groups. CONCLUSIONS: These are the first empirical findings on free, online contraception and suggest that early adopters broadly reflect the population of the local area in terms of ethnic diversity and deprivation as measured by IMD. Ongoing service development should prioritise the identification and removal of barriers which may inhibit repeat use for black and minority ethnic groups.

Economic evaluation of a novel genetic screening test for risk of venous thromboembolism compared with standard of care in women considering combined hormonal contraception in Switzerland.

AIM: The aim of this study was to assess the cost effectiveness of the Pill Protect (PP) genetic screening test for venous thromboembolism (VTE) risk compared with standard of care (SoC), for women considering combined hormonal contraceptives (CHCs) in Switzerland. METHODS: A two-part microsimulation model was developed to estimate VTE events, costs and quality-adjusted life years (QALYs) associated with the PP and SoC strategies. In the first portion of the model, a cohort of 1 million Swiss first-time seekers of a CHC were simulated. It was determined whether each women would receive a CHC or non-CHC by using prescribing patterns elicited from a modified Delphi study. These results formed the basis of the SoC strategy. For the PP strategy, a PP test was included and the results considered in addition to SoC practice. Each woman then entered a Markov model that captured morbidity and mortality over a lifetime. The risk of having a VTE was derived from the risk algorithm that underpins the PP test. The remaining model inputs relating to population characteristics, costs, health resource use, mortality and utilities were derived from published studies or national sources. The model was validated and calibrated to align with population-based studies. Extensive uncertainty analyses were conducted. RESULTS: From a Swiss health system perspective, the PP strategy in comparison with the SoC strategy generated an additional CHF 231, and gained 0.003 QALYs per woman, leading to an incremental cost-effectiveness ratio of CHF 76 610 per QALY gained. Assuming a threshold of CHF 100 000 per QALY gained, the PP strategy is likely to be cost effective. Our results were generally robust to variations in the parameter values. CONCLUSIONS: The PP test may be cost effective in Switzerland for screening women seeking CHCs for their risk of VTE based on the current evidence.

Effects of Estrogen Therapies on Outcomes in Turner Syndrome: Assessment of Induction of Puberty and Adult Estrogen Use.

CONTEXT: Turner syndrome (TS) is often associated with delayed puberty. To induce puberty, estrogen is administered in incremental doses at an age determined by age of presentation. After puberty, various types of maintenance estrogen replacement therapy (ERT) are used. OBJECTIVE: We sought associations between age of induction of puberty and type of ERT on adult health outcomes. DESIGN: Health surveillance data included blood profiles, bone density, and blood pressure. We assessed interactions between these data and age at first estrogen exposure in women with primary amenorrhea. We also assessed these data according to ERT subgroups [combined oral contraceptive pill (OCP), oral estrogen (OE), and transdermal estradiol (TE)] using data from each of 6679 clinic visits, controlling for age, body mass index, and height. SETTING: Adult TS clinic at University College London Hospital. PATIENTS: Of 799 women with TS, 624 had primary amenorrhea and 599 had accurate maintenance ERT data. MAIN OUTCOME MEASURES: Parameters of health surveillance derived from clinical guidelines. RESULTS: Estrogen start age was negatively correlated with adult bone density (spine: r = -0.20 and hip: r = -0.022; P ≤ 0.001). OCP users had higher blood pressure and an adverse lipid profile compared with other ERT subgroups. TE was associated with elevated liver enzymes and hemoglobin A1c compared with OE (P ≤ 0.01). CONCLUSIONS: An earlier age of induction of puberty may be beneficial for adult bone density. Given the high prevalence of hypertension in TS, the use of OCP for ERT should be limited. OE may be a benefit for steatohepatitis.

A systematic review of cost-effectiveness analysis of screening interventions for assessing the risk of venous thromboembolism in women considering combined oral contraceptives.

Use of combined oral contraceptives (COCs) by women increases the risk of venous thromboembolism (VTE), which can have a major impact on an individuals' quality of life. VTE is also associated with an increase in healthcare costs. Our aim was to systematically review cost-effectiveness analyses (CEAs) considering any screening for risk of VTE in women using COCs. The quality of reporting in each study was assessed, a summary of results was prepared, and the key drivers of cost effectiveness in each of the eligible CEAs were identified. A search strategy using MeSH terms was performed in MEDLINE, Embase, the Centre for Review and Dissemination (CRD) database including the Economic Evaluation Database from the UK National Health Service, and Cochrane reviews. Two reviewers independently screened and determined the final articles, and a third reviewer resolved any discrepancies. Consolidated Health Economic Evaluation Reporting Standards was used to assess the quality of reporting in terms of perspective, effectiveness measures, model structure, cost, time-horizon and discounting. Four publications (three from Europe, one from the United States) were eligible for inclusion in the review. According to current criteria, relevant elements were sometimes not captured and the sources of epidemiological and effectiveness data used in the CEAs were of limited quality. The studies varied in terms of type of costs assessed, country settings, model assumptions and uncertainty around input parameters. Key drivers of CEAs were sensitivity and specificity of the test, incidence rate of VTE, relative risk of prophylaxis, and costs of the test. The reviewed studies were too dissimilar to draw a firm conclusion on cost-effectiveness analysis about universal and selective screening in high-risk groups. The new emerging diagnostic tools for identifying women at risk of developing VTE, that are more predictive and less costly, highlight the need for more studies that apply the latest evidence and utilize robust methods for cost-effectiveness analysis. This information is required to improve decision making for this pertinent issue within personalized medicine.

Assessment of Anti-Müllerian Hormone Level in Management of Adolescents with Polycystic Ovary Syndrome.

OBJECTIVE: This study was oriented to investigate the benefit of anti-Müllerian hormone (AMH) level in the management of polycystic ovary syndrome (PCOS). To assess the impact of metformin and oral contraceptives (OC) on serum AMH levels in a cohort of adolescents with PCOS. METHODS: Forty-nine adolescents with PCOS were recruited to the study. Twenty-nine patients without insulin resistance were treated with OC (group 1), and 20 patients with insulin resistance were treated with metformin and OC (group 2). AMH and androgen levels were measured prior to and 6 months after the initiation of treatment. RESULTS: AMH levels were significantly decreased with treatment in both group 1 (p=0.006) and group 2 (p=0.0048). There was a significant correlation between pre- and post-treatment AMH and left ovarian volume (pretreatment: rho=0.336, p=0.018; post-treatment: rho=0.310, p=0.034). CONCLUSION: This study investigated two different treatment regimens in adolescents with PCOS and revealed that AMH levels decreased with treatment. AMH levels were correlated with ovarian volume.

The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013.

This systematic literature review was conducted to summarize the direct and indirect costs per patient that are associated with uterine fibroid tumors in international studies. A search with predefined search terms was conducted in MEDLINE and EMBASE for studies that were published from January 2000 to November 2013. The review included primary studies that were in English and that reported either direct costs (drug costs, procedure costs, and medical service costs) or indirect costs (such as productivity loss) among patients with uterine fibroid tumors. A total of 26 studies that were identified and included in the data extraction included 19 studies in the United States, 2 studies in the Netherlands, 1 study each in Germany, China, Italy, and Canada, and 1 study reported data that were collected from 3 countries: Germany, France, and England. The studies differed substantially in perspectives that were adopted for analysis, research designs, data elements that were collected, setting, populations, and outcome measurements. Among 3 studies that reported total direct costs during the year after uterine fibroid tumor diagnosis, 2 studies reported an average of $9473 and $9319 per patient, respectively; 2 studies reported the excess costs over controls to be $6076 and $5427, respectively. The indirect costs per patient ranged from $2399-15,549, and the excess indirect cost per patient over control groups ranged from $323-4824 in the year after the diagnosis. The total costs, sum of direct and indirect costs, ranged from $11,717-25,023 per patient per year, after diagnosis or surgery among patients with uterine fibroid tumors. Compared with control subjects, the additional annual cost ranged from $2200-15,952 per patient. The results of this systematic literature review highlight the substantial direct and indirect costs that are associated with uterine fibroid tumors to health care payers and society. The large number and the variety of studies identified also emphasize the growing awareness of the significant economic impact of uterine fibroid tumors. Current gaps that were identified through this review warrant further investigation to elucidate fully the economic burden of uterine fibroid tumors, including, but not limited to, burden from the patient's perspective and the entirety of indirect costs.

Cost-effectiveness analysis in the treatment of heavy menstrual bleeding in Spain.

OBJECTIVE: To compare the effectiveness and costs associated with first-line medical treatments for chronic heavy menstrual bleeding (HMB) in Spain. STUDY DESIGN: A cost-effectiveness analysis was conducted comparing the levonorgestrel-releasing intrauterine system (LNG-IUS) with the estradiol valerate/dienogest multiphase oral contraceptive (E2V/DNG), combined oral contraceptives (COC) and progestins (PROG). Study patients were fertile women diagnosed with HMB who initially wished to remain fertile. A Markov model based on reported clinical data and the opinion of a panel of experts was used. The time horizon of the analysis was 5 years. The analysis was conducted from the perspective of the Spanish National Health System (NHS), discounting both costs (€ 2013) and future effects at an annual rate of 3%. One-way sensitivity analyses and probabilistic sensitivity analysis were performed to test the robustness of the results. RESULTS: In the analysis at 5 years, the LNG-IUS was associated with a gain of 0.67, 2.22, and 3.53 symptoms free months (SFM) compared with E2V/DNG, COC and PROG, respectively. LNG-IUS contributed more quality-adjusted life months (QALM) than the other treatment alternatives (+1.74 vs. E2V/DNG, +3.33 vs. COC +3.53 vs. PROG). First-line LNG-IUS treatment resulted in savings of € 583, € 988, and € 1891 vs. E2V/DNG, COC and PROG, respectively. These cost benefits, coupled with the greater clinical benefits in terms of SFM and QALM, show that LNG-IUS is the dominant option (less costly and more effective). CONCLUSION: LNG-IUS is the medical treatment of choice and cost-saving option for the control of HMB in Spain.

Current challenges in contraception in adolescents and young women.

PURPOSE OF REVIEW: Although developing countries have made much progress in expanding the availability and use of family planning services, the need for effective contraception is large, and growing because the largest cohorts in human history are entering their reproductive years. Not only regarding developing countries but also in developed countries, where the usual contraceptive methods, such as the oral contraceptives, intrauterine devices (IUDs) and condoms, have been available for decades, there have been many new advances in contraceptive technology in the last several years. New formulations of oral contraceptives, extended and continuous use of oral contraceptives and long-acting reversible contraceptives (LARC) may have a wider role in contraception and their increased implementation could help to reduce unintended pregnancy. RECENT FINDINGS: Today's oral contraceptive regimens are safer and more tolerable, with equal or improved efficacy as compared to early formulations. Incremental decreases in the estrogen dosage have helped to alleviate some of the unwanted estrogenic side effects of combined hormonal contraceptives. Progestogens have also been controversial in connection with findings of increased venous thromboembolism risks but they have evolved over time, and, in general, newer generations of progestins have minimal side effects. Currently available 'LARC' methods, such as IUDs, the intrauterine system, injectable contraceptives and implants require administration less than once per cycle or month. They are more cost effective than the combined oral contraceptive pill even at 1 year of use. Increasing the access and availability of new formulations of oral contraceptives and LARC methods will reduce the number of unintended pregnancies. SUMMARY: Evidence-based guidelines about the safety of contraceptive methods among women with comorbid medical conditions can help guide providers in determining the best method of contraception for each woman, depending on whether they are in their adolescent, postpartum or perimenopause years. As most patients can safely use highly effective methods of contraception, health providers should promote their use in order to further efforts to reduce unintended pregnancy. This promotion should be done by enabling women to make an informed choice among all contraceptive options.

Estradiol valerate/dienogest: a novel combined oral contraceptive.

BACKGROUND: Estradiol valerate/dienogest (E2V/DNG) is a combined oral contraceptive (COC) with 2 new hormonal entities and a unique 4-phasic dosing regimen indicated for women to prevent pregnancy. OBJECTIVE: The purpose of this article is to review the pharmacology, pharmacokinetics, clinical efficacy, tolerability, and cost of E2V/DNG. METHODS: MEDLINE (1966-June 2011) and EMBASE (1966-June 2011) were searched for original research and review articles published in the English language using the terms Natazia or Qlaira or estradiol valerate and dienogest. The reference lists of identified articles were reviewed for additional pertinent publications. Abstracts from the 2005 to 2011 American Society of Reproductive Medicine and American College of Obstetricians and Gynecologists meetings were searched using the same terms. RESULTS: The search provided 56 articles that addressed the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, and tolerability of E2V/DNG in women of reproductive age. Articles reporting efficacy or tolerability in the setting of menopause were excluded. The initial efficacy of E2V/DNG on ovulation inhibition was investigated in 2 prospective, randomized, open-label, Phase II dose-finding studies. The dose that was approved by the Food and Drug Administration resulted in 3.13% of women ovulating in the second cycle of treatment (90% CI, 0.2%-6.05%). Rate of pregnancy prevention with this agent was reported with a Pearl Index ranging from 0.73 to 1.27 (unadjusted) to 0.34 to 0.72 (adjusted for method failure only). The mean duration of withdrawal bleeding was 4.3 days (range, 4.0-4.6 days) among 2266 women receiving 13 treatment cycles. Adverse events reported in >1% of patients included abdominal pain, acne, breast pain, dysmenorrhea, emotional lability, headache, nausea, and weight increase. CONCLUSIONS: Estradiol valerate/dienogest is a new contraceptive formulation. It offers efficacy, tolerability, and an acceptable safety profile with a potentially better bleeding pattern than levonorgestrel-containing COCs. This COC may be especially useful for older women of reproductive age who are adherent to therapy and looking for shorter and/or lighter menstrual cycles. Studies will need to be performed to determine whether clinically significant differences in outcomes exist among E2V/DNG and other available COCs.

Quantification of the adverse effect of ethinylestradiol containing oral contraceptive pills when used in conjunction with growth hormone replacement in routine practice.

OBJECTIVE: Oestrogen antagonizes the action of growth hormone (GH). For women with combined GH and oestrogen deficiency, transdermal oestradiol is more favourable in this regard compared to oral oestradiol. Oral contraceptive pills containing ethinylestradiol (EE) are commonly used in young women with GHD and there is little information on the impact of this form of oestrogen. DESIGN: A case note review of women with growth hormone deficiency (GHD) attending a tertiary endocrine clinic comparing the dose of GH and serum insulin-like growth factor 1 concentrations and the type of exogenous oestrogen. METHODS: All women with GHD between the ages of 18 and 47 attending University College London Hospitals (UCLH) were included and grouped according to type of oestrogen replacement. Weight, GH dose and serum IGF-I concentrations were recorded at 121 visits in 88 women. RESULTS: The daily dose of GH was significantly higher and the GH responsivity was significantly lower in the EE group compared to those taking no oestrogen and transdermal oestrogen. The additional cost of GH for women using EE compared to transdermal oestradiol was £6016 per patient per year. Effectiveness of GH improved in all women changing from EE to another form of oestrogen. CONCLUSION: Use of oral contraceptive pills containing EE should be avoided in women receiving treatment with GH. Alternative options include oral or transdermal hormone replacement therapy (HRT) preparations for those that require oestrogen replacement or a progesterone-based regimen for contraceptive purposes.

Economic evaluation of the levonorgestrel-releasing intrauterine system for the treatment of dysfunctional uterine bleeding in Spain.

OBJECTIVE: To compare the cost and effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) versus combined oral contraception (COC) and progestogens (PROG) in first-line treatment of dysfunctional uterine bleeding (DUB) in Spain. STUDY DESIGN: A cost-effectiveness and cost-utility analysis of LNG-IUS, COC and PROG was carried out using a Markov model based on clinical data from the literature and expert opinion. The population studied were women with a previous diagnosis of idiopathic heavy menstrual bleeding. The analysis was performed from the National Health System perspective, discounting both costs and future effects at 3%. In addition, a sensitivity analysis (univariate and probabilistic) was conducted. RESULTS: The results show that the greater efficacy of LNG-IUS translates into a gain of 1.92 and 3.89 symptom-free months (SFM) after six months of treatment versus COC and PROG, respectively (which represents an increase of 33% and 60% of symptom-free time). Regarding costs, LNG-IUS produces savings of € 174.2-309.95 and € 230.54-577.61 versus COC and PROG, respectively, after 6 months-5 years. Apart from cost savings and gains in SFM, quality-adjusted life months (QALM) are also favourable to LNG-IUS in all scenarios, with a range of gains between 1 and 2 QALM compared to COC and PROG. CONCLUSIONS: The results indicate that first-line use of the LNG-IUS is the dominant therapeutic option (less costly and more effective) in comparison with first-line use of COC or PROG for the treatment of DUB in Spain. LNG-IUS as first line is also the option that provides greatest health-related quality of life to patients.

The menstrual disorder of teenagers (MDOT) study: determining typical menstrual patterns and menstrual disturbance in a large population-based study of Australian teenagers.

OBJECTIVE: The aim of this study was to: (1) establish the typical experience of menstruation for senior high school girls and (2) determine how many experience considerable menstrual disturbance that could require further investigation and management of underlying pathology. DESIGN: Cross-sectional study. SETTING: Senior High Schools in the Australian Capital Territory (ACT), Australia. POPULATION: A total of 1051 girls aged between 15 and 19 years. METHODS: Data based on a quantitative survey. MAIN OUTCOME MEASURES: Self-reports of menstrual bleeding patterns, typical and atypical symptoms and morbidities. RESULTS: Typical menstruation in adolescence includes pain (93%), cramping (71%), premenstrual symptoms (96%) and mood disturbance (73%). Highly significant associations were found between increasing severity of menstrual pain, number of menstrual-related symptoms, interference with life activities and school absence. These associations indicate that approximately 25% of the sample had marked menstrual disturbance: 21% experienced severe pain; 26% school absence; 26% suffering five or more symptoms; > or =24% reporting moderate to high interference with four out of nine life activities. Approximately 10% reported atypical symptoms associated with menstruation. Diagnosis of menstrual pathology in the sample was low, even though 33% had seen a GP and 9% had been referred to a specialist. CONCLUSIONS: Menstrual pain and symptoms are common in teenagers. Girls indicating moderate to severe pain in association with a high number of menstrual symptoms, school absence and interference with life activities should be effectively managed to minimise menstrual morbidity. Those girls who do not respond to medical management should be considered for further investigation for possible underlying pathology, such as endometriosis.

A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment.

OBJECTIVE: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris. METHODS: Healthy females (14-45 years old) with moderate facial acne were randomized to 3 mg drsp/20 microg EE 24/4 (n = 270) or placebo (n = 268) for six cycles. The secondary efficacy variables measured included change from baseline to endpoint (cycle 6) in individual lesion count for nodules, papules, pustules, open and closed comedones. RESULTS: There were significantly greater reductions in individual lesion counts from baseline to endpoint in the 3 mg drsp/20 microg EE group than in the placebo group (P < 0.05 from parametric model). CONCLUSION: The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions.

A combined oral contraceptive containing 3-mg drospirenone/ 20-microg ethinyl estradiol in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled study evaluating lesion counts and participant self-assessment.

This study compared the efficacy of a low-dose combined oral contraceptive (COC) containing 3-mg drospirenone and 20-microg ethinyl estradiol (3-mg DRSP/20-microg EE) administered in a 24-day active pill/4-day inert pill (24/4) regimen and placebo in women with moderate acne vulgaris during 6 treatment cycles. A total of 534 participants were randomized and dispensed study medication (n = 266 [3-mg DRSP/20-microg EE 24/4 regimen COC group]; n = 268 [placebo group]). Women of reproductive age were eligible for inclusion in the study. Treatment with the 3-mg DRSP/20-microg EE 24/4 regimen COC was associated with a greater reduction from baseline to end point in individual lesion counts (papules, pustules, open and closed comedones) compared with placebo. The mean nodule count remained essentially constant throughout the study and was low in both treatment groups. There was a significantly higher probability that a participant had an improved assessment on the investigator's overall improvement rating scale (odds ratio [OR], 4.02; 95% CI [confidence interval], 2.29-7.31; P < .0001) and participant's overall self-assessment rating scale (OR, 2.82; 95% CI, 1.60-5.13; P = .0005) in the 3-mg DRSP/20-microg EE 24/4 regimen COC group than in the placebo group. The COC 3-mg DRSP/20-microg EE 24/4 regimen is a suitable option for women with moderate acne vulgaris who require contraception.

Oral contraceptives in polycystic ovary syndrome: risk-benefit assessment.

Combined oral contraceptive pills (OCPs) have been a key component of the chronic treatment of polycystic ovary syndrome (PCOS) by improving androgen excess and regulating menstrual cycles. Earlier epidemiologic studies with second- and third-generation OCPs in the general population have raised important questions regarding long-term cardiometabolic effects of these agents. In PCOS, there are only a few short-term studies with contradictory results evaluating potential adverse effects of OCPs on cardiovascular risk factors and glucose homeostasis. These studies included a small number of participants and did not take into account several confounding factors that might influence the outcome. Nevertheless, limited available data support the benefits of long-term OCP use in PCOS. By contrast, solid evidence for cardiometabolic adverse outcome with the use of these agents, especially with newer OCPs containing antiandrogenic progestins, is lacking. More studies are needed to resolve controversies regarding the safety of long-term OCP use in PCOS. Meanwhile, assessment of each PCOS patient's personal cardiometabolic risk profile should be an essential component of the evaluation before prescribing OCPs and also during follow-up.