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The Cochrane Database of Systematic... Jun 2023Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC),... (Review)
Review
BACKGROUND
Premenstrual syndrome (PMS) is a common problem. Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syndrome. Combined oral contraceptives (COC), which provide both progestin and oestrogen, have been examined for their ability to relieve premenstrual symptoms. A combined oral contraceptive containing drospirenone and a low oestrogen dose has been approved for treating PMDD in women who choose combined oral contraceptives for contraception.
OBJECTIVES
To evaluate the effectiveness and safety of COCs containing drospirenone in women with PMS.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility Group trial register, CENTRAL (now containing output from two trials registers and CINAHL), MEDLINE, Embase, PsycINFO, LILACS, Google Scholar, and Epistemonikos on 29 June 2022. We checked included studies' reference lists and contacted study authors and experts in the field to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCT) that compared COCs containing drospirenone with placebo or with another COC for treatment of women with PMS.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. The primary review outcomes were effects on premenstrual symptoms that were prospectively recorded, and withdrawal due to adverse events. Secondary outcomes included effects on mood, adverse events, and response rate to study medications.
MAIN RESULTS
We included five RCTs (858 women analysed, most diagnosed with PMDD). The evidence was very low to moderate quality; the main limitations were serious risk of bias due to poor reporting of study methods, and serious inconsistency and imprecision. COCs containing drospirenone and ethinylestradiol (EE) versus placebo COCs containing drospirenone and EE may improve overall premenstrual symptoms (standardised mean difference (SMD) -0.41, 95% confidence interval (CI) -0.59 to -0.24; 2 RCTs, N = 514; I = 64%; low-quality evidence); and functional impairment due to premenstrual symptoms in terms of productivity (mean difference (MD) -0.31, 95% CI -0.55 to -0.08; 2 RCTs, N = 432; I = 47%; low-quality evidence), social activities (MD -0.29, 95% CI -0.54 to -0.04; 2 RCTs, N = 432; I = 53%; low-quality evidence), and relationships (MD -0.30, 95% CI -0.54 to -0.06; 2 RCTs, N = 432; I = 45%; low-quality evidence). The effects from COCs containing drospirenone may be small to moderate. COCs containing drospirenone and EE may increase withdrawal from trials due to adverse effects (odds ratio (OR) 3.41, 95% CI 2.01 to 5.78; 4 RCT, N = 776; I = 0%; low-quality evidence). This suggests that if you assume the risk of withdrawal due to adverse effects from placebo is 3%, the risk from drospirenone plus EE will be between 6% and 16%. We are uncertain of the effect of drospirenone plus EE on premenstrual mood symptoms, when measured by validated tools that were not developed to assess premenstrual symptoms. COCs containing drospirenone may lead to more adverse effects in total (OR 2.31, 95% CI 1.71 to 3.11; 3 RCT, N = 739; I = 0%; low-quality evidence). This suggests that if you assume the risk of having adverse effects from placebo is 28%, the risk from drospirenone plus EE will be between 40% and 54%. It probably leads to more breast pain, and may lead to more nausea, intermenstrual bleeding, and menstrual disorder. Its effect on nervousness, headache, asthenia, and pain is uncertain. There was no report of any rare but serious adverse effects, such as venous thromboembolism in any of the included studies. COCs containing drospirenone may improve response rate (OR 1.65, 95% CI 1.13 to 2.40; 1 RCT, N = 449; I not applicable; low-quality evidence). This suggests that if you assume the response rate from placebo is 36%, the risk from drospirenone plus EE will be between 39% and 58%. We did not identify any studies that compared COCs containing drospirenone with other COCs.
AUTHORS' CONCLUSIONS
COCs containing drospirenone and EE may improve premenstrual symptoms that result in functional impairments in women with PMDD. The placebo also had a significant effect. COCs containing drospirenone and EE may lead to more adverse effects compared to placebo. We do not know whether it works after three cycles, helps women with less severe symptoms, or is better than other combined oral contraceptives that contain a different progestogen.
Topics: Female; Humans; Contraceptives, Oral, Combined; Drug-Related Side Effects and Adverse Reactions; Estrogens; Premenstrual Dysphoric Disorder; Premenstrual Syndrome; Progestins
PubMed: 37365881
DOI: 10.1002/14651858.CD006586.pub5 -
PloS One 2023Data regarding the use and effect of hormonal contraceptives on bone mass acquisition during adolescence are contradictory. The present study was designed to evaluate... (Clinical Trial)
Clinical Trial
OBJECTIVE
Data regarding the use and effect of hormonal contraceptives on bone mass acquisition during adolescence are contradictory. The present study was designed to evaluate bone metabolism in two groups of healthy adolescents using combined oral contraceptives (COC).
METHODS
A total of 168 adolescents were recruited from 2014 to 2020 in a non-randomized clinical trial and divided into three groups. The COC1 group used 20 μg Ethinylestradiol (EE)/150 μg Desogestrel and the COC2 group used 30 μg EE/3 mg Drospirenone over a period of two years. These groups were compared to a control group of adolescent non-COC users. The adolescents were submitted to bone densitometry by dual-energy X-ray absorptiometry and measurement of bone biomarkers, bone alkaline phosphatase (BAP), and osteocalcin (OC) at baseline and 24 months after inclusion in the study. The three groups studied were compared at the different time points by ANOVA, followed by Bonferroni's multiple comparison test.
RESULTS
Incorporation of bone mass was greater in non-users at all sites analyzed (4.85 g in lumbar Bone mineral content (BMC)) when compared to adolescents of the COC1 and COC2 groups, with a respective increase of 2.15 g and loss of 0.43g in lumbar BMC (P = 0.001). When comparing subtotal BMC, the control increased 100.83 g, COC 1 increased 21.46 g, and COC 2 presented a reduction of 1.47 g (P = 0.005). The values of bone markers after 24 months are similar for BAP, being 30.51 U/L (± 11.6) for the control group, 34.95 U/L (± 10.8) for COC1, and 30.29 U/L for COC 2 (± 11.5) (P = 0.377). However, when we analyzed OC, we observed for control, COC 1, and COC 2 groups, respectively, 13.59 ng/mL (± 7.3), 6.44 ng/mL (± 4.6), and 9.48 ng/mL (± 5.9), with P = 0.003. Despite loss to follow-up occurring in the three groups, there were no significant differences between the variables in adolescents at baseline who remained in the study during the 24-month follow-up and those who were excluded or lost to follow-up.
CONCLUSION
Bone mass acquisition was compromised in healthy adolescents using combined hormonal contraceptives when compared to controls. This negative impact seems to be more pronounced in the group that used contraceptives containing 30 μg EE.
CLINICAL TRIAL REGISTRATION
http://www.ensaiosclinicos.gov.br, RBR-5h9b3c. "Low-dose combined oral contraceptive use is associated with lower bone mass in adolescents".
Topics: Female; Adolescent; Humans; Ethinyl Estradiol; Contraceptives, Oral, Combined; Bone and Bones; Bone Density; Absorptiometry, Photon; Control Groups
PubMed: 37289781
DOI: 10.1371/journal.pone.0285885 -
Journal of Affective Disorders Jan 2024The link between oral contraceptive pill (OCP) and depression is still unclear. This work analyses the prevalence and correlates of major depression in US women using...
BACKGROUND
The link between oral contraceptive pill (OCP) and depression is still unclear. This work analyses the prevalence and correlates of major depression in US women using OCP.
METHODS
This study used the National Health and Nutrition Examination Survey (NHANES) 2005-2012 data to provide the prevalence and correlates of major depression in women using OCP. Major depression was defined as a score of ≥10 using the Patient Health Questionnaire-9 (PHQ-9).
RESULTS
A total of 6239 women aged 18-55 years were included in the present analysis. Current OCP users had a lower prevalence of major depression (4.6 %; 95 % CI, 3.2 to 6.6) compared to former users of OCP (11.4 %; 95 % CI, 10.1 to 12.9) and never users of OCP (10 %; 95 % CI, 8.3 to 12.1). Current users of OCP were significantly less likely to report major depression compared to former users of OCP (OR 0.59; 95CI%, 0.39 to 0.90) after adjusting for potential confounders. The prevalence of major depression was higher in women who were: black or Hispanic, widowed/divorced/separated, those with a low and middle income, current smokers, current users of antidepressants, and with history of cancer and thyroid problems.
LIMITATIONS
This is a cross-sectional study.
CONCLUSION
The prevalence of major depression among women using OCP may be lower than in former users of OCP, however, the burden of depression remains high. Further research with longitudinal follow-up for depression in women using OCP is needed to understand real world effect of the OCP on depression.
Topics: Humans; Female; Contraceptives, Oral; Nutrition Surveys; Depression; Cross-Sectional Studies; Depressive Disorder, Major
PubMed: 37832730
DOI: 10.1016/j.jad.2023.10.041 -
Ugeskrift For Laeger Jun 2020Hormonal contraception is widely used among young women, and mood changes are common side effects. Little focus has been drawn towards more serious mood disorders.... (Review)
Review
Hormonal contraception is widely used among young women, and mood changes are common side effects. Little focus has been drawn towards more serious mood disorders. Recent investigations have shown an association between hormonal contraceptive use and depression, suicide attempt and suicide. The highest relative risks for those side effects have been reported among adolescents. All types of hormonal contraceptive methods seem to influence women's mood. In this review, we recommend a greater focus on potential psychological side effects and increased attention when prescribing hormonal contraceptive products.
Topics: Adolescent; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Depression; Female; Humans; Mood Disorders; Risk; Suicide, Attempted
PubMed: 32584759
DOI: No ID Found -
Women's Health (London, England) 2023Despite all efforts in Jordan to increase the demand and use of family planning services, many challenges have likely influenced fertility and contraceptive use... (Review)
Review
BACKGROUND
Despite all efforts in Jordan to increase the demand and use of family planning services, many challenges have likely influenced fertility and contraceptive use outcomes. Improving accessibility and availability of family planning services and interventions to married women and their spouse is essential to improve pregnancy outcomes.
OBJECTIVES
This study reviewed the gray and peer-reviewed literature published between January 2010 and June 2022 that described family planning interventions implemented in Jordan and highlighted the gaps identified in the literature.
ELIGIBILITY CRITERIA
For inclusion, primary studies that included information regarding family planning interventions implemented in Jordan were retained.
SOURCES OF EVIDENCE
PubMed database was searched between 2010 till June 2022, as well as bibliographies of the retrieved literature were screened for the relevant literature.
CHARTING METHODS
Information extracted from the interventions included author, publication year, study design and purpose, intervention name, aim of the intervention, population descriptor and sample size of the intervention, and impact of the intervention.
RESULTS
A total of 10 studies that met the inclusion criteria were reviewed. The studies described/assessed 10 different interventions including communication interventions, child preparation programs, evidence-based educational program, counseling interventions, pharmacist booklet on effective use of oral contraceptive pills and Village Health Center project. Five family planning interventions targeted women and five targeted health care providers. Three interventions targeted men, two targeted religious leaders, and two targeted community health committees. Many of the interventions suffered from a lack of a robust methodological framework.
CONCLUSION
This scoping review showed that there is scarce information on the implementation of High Impact Practices in Family Planning in Jordan. The review identified a lack of robust evidence on the impact and effectiveness of family planning interventions on the access to and use of family planning services and methods. There is a need for developing, implementing, and evaluating family planning interventions that elicit a positive environment and encourage the use of family planning services.
Topics: Child; Female; Humans; Male; Pregnancy; Contraception; Contraceptives, Oral; Counseling; Family Planning Services; Jordan
PubMed: 37119031
DOI: 10.1177/17455057231170977 -
Gynecological Endocrinology : the... Dec 2023In recent years, new combined oral contraceptives (COCs) have become available, representing an advance in terms of individualization and compliance by users. To... (Review)
Review
In recent years, new combined oral contraceptives (COCs) have become available, representing an advance in terms of individualization and compliance by users. To provide recommendations regarding COCs: formulations, use, efficacy, benefits and safety. For these recommendations, we have used the modified Delphi methodology and carried out a systematic review of studies found in the literature and reviews performed in humans, published in English and Spanish in Pubmed, Medline and advanced medicine and computer networks until the year 2021, using the combination of terms: 'oral contraceptives', 'estroprogestins' and 'combined oral contraceptives'. Regarding the estrogen component, initially switching from mestranol (the pro-drug of ethinylestradiol) to ethinylestradiol (EE) and then reducing the EE dose helped reduce side effects and associated adverse events. Natural estradiol and estradiol valerate are already available and represent a valid alternative to EE. The use of more potent 19-nortestosterone-derived progestins, in order to lower the dose and then the appearance of non-androgenic progestins with different endocrine and metabolic characteristics, has made it possible to individualize the prescription of COC according to the profile of each woman. Advances in the provision of new COCs have improved the risk/benefit ratio by increasing benefits and reducing risks. Currently, the challenge is to tailor contraceptives to individual needs in terms of safety, efficacy, and protection of female reproductive health.
Topics: Female; Humans; Contraceptives, Oral, Combined; Progestins; Latin America; Ethinyl Estradiol; Estrogens; Women's Health
PubMed: 37857350
DOI: 10.1080/09513590.2023.2271072 -
Drug Metabolism and Disposition: the... Jun 2023Combined oral contraceptives (COCs) are widely used in women of reproductive age in the United States. Metabolism plays an important role in the elimination of estrogens... (Review)
Review
Combined oral contraceptives (COCs) are widely used in women of reproductive age in the United States. Metabolism plays an important role in the elimination of estrogens and progestins contained in COCs. It is unavoidable that a woman using COCs may need to take another drug to treat a disease. If the concurrently used drug induces enzymes responsible for the metabolism of progestins and/or estrogens, unintended pregnancy or irregular bleeding may occur. If the concurrent drug inhibits the metabolism of these exogenous hormones, there may be an increased safety risk such as thrombosis. Therefore, for an investigational drug intended to be used in women with reproductive potential, evaluating its effects on the pharmacokinetics of COCs is important to determine if additional labeling is necessary for managing drug-drug interactions (DDIs) between the concomitant product and the COCs. It is challenging to determine when this clinical drug interaction study is needed, whether an observed exposure change of progestin/estrogen is clinically meaningful, and if the results of a clinical drug interaction study with one COC can predict exposure changes of unstudied COCs to inform labeling. In this review, we summarize the current understanding of metabolic pathways of estrogens and progestins contained in commonly used COCs and known interactions of these COCs as victim drugs and we discuss possible mechanisms of interactions for unexpected results. We also discuss recent advances, knowledge gaps, and future perspectives on this important topic. The review will enhance the understanding of DDIs with COCs and improve the safe and effective use of COCs. SIGNIFICANCE STATEMENT: This minireview provides an overview of the metabolic pathways of ethinyl estradiol and progestins contained in commonly used combined oral contraceptives (COCs) and significant drug interactions of these COCs as victims. It also discusses recent advances, knowledge gaps, future perspectives, and potential mechanisms for unexpected results of clinical drug interaction studies of COCs. This minireview will help the reader understand considerations when evaluating the drug interaction potential with COCs for drugs that are expected to be used concurrently.
Topics: Female; Humans; Contraceptives, Oral, Combined; Progestins; Ethinyl Estradiol; Estrogens; Drug Interactions
PubMed: 36963837
DOI: 10.1124/dmd.122.000854 -
Contraception Mar 2023To synthesize published literature on POP effectiveness and efficacy. (Review)
Review
OBJECTIVES
To synthesize published literature on POP effectiveness and efficacy.
STUDY DESIGN
We searched PubMed Central, PubMed, and the Cochrane library through March 07, 2022. We included articles written in English reporting a Pearl Index or life table rate for pregnancy. We excluded articles only assessing formulations that: were never marketed globally, are only sold in combination with estrogen, are currently sold only for noncontraceptive purposes, or were not given to participants continuously. Four researchers independently extracted data and two analyzed data using Excel and R.
RESULTS
We included 54 studies. Among studies at low or moderate risk of bias, the median Pearl Index rate (the failure rate during typical use) was 1.63 (range 0.00-14.20, IQR 4.03) and the median method failure Pearl Index rate (the failure rate during perfect use) was 0.97 (range 0.40-6.50, IQR 0.68). Excluding the newer formulations, Desogestrel and Drospirenone, which are closer to combined oral contraceptives in that they prevent pregnancy by inhibiting ovulation, the median Pearl Index rate is 2.00 (range 0.00-14.12, IQR 2.5) and the median method failure Pearl Index rate is 1.05 (range 0.00-10.90, IQR 1.38).
CONCLUSIONS
Among studies at low or moderate risk of bias, the median Pearl Index rate during typical POP use was much lower than currently estimated (7.00), while the median perfect use rate was similar to current estimates.
IMPLICATIONS
Future research should investigate the possibility that POPs may be much more effective during typical use than currently believed.
Topics: Pregnancy; Female; Humans; Desogestrel; Progestins; Contraceptives, Oral, Combined; Estrogens; Ovulation
PubMed: 36535414
DOI: 10.1016/j.contraception.2022.109925 -
Journal of the National Cancer Institute Apr 2022
Topics: Contraceptives, Oral; Female; Genes, BRCA1; Genes, BRCA2; Humans; Neoplasms
PubMed: 35048983
DOI: 10.1093/jnci/djac006 -
Bulletin of the World Health... Aug 2022Self-care interventions include over-the-counter contraceptives, which enable individuals to make informed, autonomous decisions about fertility management. As there is... (Review)
Review
Self-care interventions include over-the-counter contraceptives, which enable individuals to make informed, autonomous decisions about fertility management. As there is a substantial unmet need for contraception in many countries, increasing access by establishing sound, affordable and effective regulation of over-the-counter contraceptives could help reduce unintended pregnancies and improve maternal health. We performed a review of 30 globally diverse countries: (i) to assess national regulatory procedures for changing oral contraceptives, emergency contraceptives and injectable contraceptives from prescription-only to over-the-counter products; and (ii) to determine whether national lists of over-the-counter medicines included contraceptives. Of the 30 countries, 13 (43%) had formal regulatory procedures in place for changing prescription-only medicines to over-the-counter medicines, 11 (36%) had national lists of over-the-counter medicines, and four (13%) included contraceptives on those lists. Changing from prescription-only to over-the-counter medicines presents challenges for national medicines regulatory authorities and manufacturers, involving, for example, reporting side-effects, quality control and the often poorly-defined process of switching to over-the-counter products. To facilitate the over-the-counter availability of contraceptives, countries should consider adopting a formal regulatory procedure for reclassifying prescription-only contraceptives as over-the-counter contraceptives. Although the availability of over-the-counter contraceptives can increase users' independence and anonymity and improve access, there may also be disadvantages, such as higher out-of-pocket costs and the need for accurate self-assessment. Basic remedial actions to improve, harmonize and standardize regulatory procedures for the reclassification of contraceptives are proposed with the aim of enabling national medicines regulatory authorities to manage the switch to over-the-counter contraceptives and to control their quality.
Topics: Contraception; Contraceptives, Oral; Female; Health Expenditures; Humans; Nonprescription Drugs; Pregnancy; Pregnancy, Unplanned
PubMed: 35923274
DOI: 10.2471/BLT.21.287561