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PubMed2003

Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms.

Oral contraception is the most widely used reversible contraceptive method. Continuous research over the past decades has led to a range of highly reliable, effective and safe oral contraceptives. Newly developed progestogens may also provide additional non-contraceptive health-related benefits that differentiate the products from each other. Women desiring contraception may thus choose from a wide range of oral contraceptives according to their individual needs. A variety of physical and emotional changes have been linked to hormonal fluctuations during the menstrual cycle. To date, only very few studies have been performed on the impact of fluid retention-related symptoms on well-being and few data are hence available on suggested methods of measurement. This open, multicenter, uncontrolled study evaluated the effects of a combined preparation containing 3 mg drospirenone and 30 microg ethinylestradiol (Yasmin, Schering AG, Berlin, Germany) on general well-being and fluid-related symptoms in women experiencing psychological, behavioral and somatic premenstrual symptoms. The study was conducted over six 28-day cycles, with 336 subjects enrolled. A significant beneficial effect on psychological general well-being, as measured by the Psychological General Well-Being Index (PGWBI), was evident by cycle 3 and maintained at cycle 6. There was a significant reduction in both the incidence and severity of somatic symptoms associated with the menstrual cycle (abdominal bloating and breast tension) during treatment. Assessment by the investigator showed that 80% of subjects had improved on study treatment and 75% of subjects considered themselves satisfied with the study treatment. There was good agreement between the clinician and subject in their assessment of the treatment. Cycle control was very good and body weight remained stable or decreased slightly during the study. In conclusion, 3 mg drospirenone in combination with 30 microg ethinylestradiol has been shown to have a beneficial effect on psychological general well-being, as measured by the PGWBI. Reductions in the incidence and severity of somatic symptoms associated with the menstrual cycle were also observed, suggesting a beneficial effect due to the antimineralocorticoid nature of drospirenone. To our knowledge, this is the first study on oral contraceptives which has used the PGWBI in this population. As quality of life is one of the least explored segments in oral contraceptive users, more studies should investigate the impact of oral contraceptives on quality of life and general well-being in this overall healthy population.

Adolescent↗
PubMed2004

Ethinylestradiol + norelgestromin: new preparation. Transdermal contraception: no tangible progress.

(1) The reference hormone-based contraceptive for women is an oral contraceptive combining ethinylestradiol (about 30 micrograms) and a well-known progestin such as levonorgestrel or norethisterone. (2) A transdermal contraceptive patch delivering 20 micrograms of ethinylestradiol and 150 micrograms of norelgestromin over 24 hours, and designed to be left in place for a whole week, three weeks a month, has recently been marketed in France. (3) Norelgestromin is the active metabolite of norgestimate, which is already available in combined contraceptives but is less well evaluated than some other progestins. Norelgestromin is metabolised by the liver, notably into norgestrel. (4) The clinical evaluation dossier of the new transdermal contraceptive contains data from two comparative unblinded trials, one versus a triphasic combination of oral ethinylestradiol + levonorgestrel, and the other versus oral ethinyl estradiol (20 micrograms) + desogestrel. A third, non comparative trial offers weaker evidence. These three trials included about 3300 women in total, and lasted between 6 and 13 cycles. The patch was about as effective as the comparator contraceptives. (5) In the three main clinical trials, 4.7% of patches had to be replaced because they became unstuck, either completely (1.8%) or partially (2.9%). (6) More women dropped out of the groups using patches (19.9% of the patch group compared with 14.5% of the group taking oral contraceptives in one trial, 29.6% versus 24.3% in the other trial). Women using the patch were more likely than other women to stop their treatment because of adverse events (about 12% versus 5%). (7) Breast discomfort, breast tenderness or pain were reported by 22% of women using the patches and by 9% and 6% of women in the two comparator groups. Women using the patches had slightly longer menstrual periods (5.6 days versus 4.7 days). Reactions at the patch site were reported by 17% of women. (8) There is no evidence that the patch is any less likely than reference oral contraceptives to cause thromboembolism. The true thromboembolic risk associated with the new patches is unknown. (9) Used patches still contain large amounts of active substances, and must be placed in sachets (provided in the packet) and taken to a pharmacy for disposal. (10) In practice, the reference combined contraceptive for women is still oral ethinylestradiol (about 30 micrograms) plus a well-known progestin such as levonorgestrel or norethisterone. Ethinylestradiol + norelgestromin patches offer women no real benefits: they are probably less convenient and may be less safe.

Administration, Cutaneous↗
PubMed1987

The relationship of tubal infertility to barrier method and oral contraceptive use.

We studied past contraceptive use in 283 nulliparous infertile women who had a diagnosis of tubal adhesions or occlusion and in 3833 women admitted for delivery at seven collaborating hospitals from 1981 to 1983. The relative risk of tubal infertility associated with barrier contraceptive use or oral contraceptive use was calculated using multivariate logistic regression to control for confounding by region, age, religion, education, smoking, number of sexual partners, time since menarche, and use of other contraceptive methods. Women who had ever used barrier methods of contraception were at a significantly decreased risk of tubal infertility (relative risk = 0.6; 95% confidence limits, 0.5 and 0.8). When type of barrier method used for the longest time was evaluated, those who used the diaphragm or condoms plus spermicides were at lower risk than those who used condoms or spermicides alone. Overall, past use of oral contraceptives neither increased nor decreased a woman's risk of tubal infertility, but there was evidence that the association between oral contraceptives and tubal infertility may vary by the amount of estrogen and type of progestogen in the oral contraceptive used. We conclude that contraceptive users who use barrier methods that combine both a mechanical and chemical barrier, such as diaphragms, cervical caps, and condoms plus spermicides, have the clearest protection against tubal damage.

Adult↗
PubMed1998

Cardiovascular disease and steroid hormone contraception. Report of a WHO Scientific Group.

Over 90 million women worldwide, including over 44 million in developing countries, are now using oral contraceptives. Despite their advantages, there is concern about the links between combined oral contraceptives and the risk of cardiovascular disease. Although most contraceptive users are healthy with a low background incidence of major disease, the very large number of women using oral contraceptives throughout the world means that even modest elevations in risk have the potential to affect a large number of women. This report presents the conclusions of a WHO Scientific Group that met to discuss the association between use of steroid hormone contraceptives (including combined oral contraceptives) and the risk of cardiovascular disease in women. The Scientific Group evaluated the data available from case-control and cohort studies on acute myocardial infarction, ischaemic and haemorrhagic stroke, and venous thromboembolism. The Group also reviewed the data on possible biological mechanisms for the effects of combined oral contraceptives on cardiovascular disease, including the interplay between lipoprotein metabolism, humoral regulators such as insulin, coagulation and fibrinolysis, the products of the endothelium of blood vessels and the renin-angiotensin-aldosterone system. The Group identified factors which may predict, for individual women, an increased risk of cardiovascular effects with use of different hormonal contraceptives, and assessed whether the various compositions of combined oral contraceptives have different risk profiles for cardiovascular disease. The report presents the Group's conclusions relating to the various types of cardiovascular disease in women of reproductive age, together with a list of recommendations for further research.

Adolescent↗
PubMed1998

Effects of contraceptives on hemoglobin and ferritin. Task Force for Epidemiological Research on Reproductive Health, United Nations Development Programme/United Nations Population Fund/World Health Organization/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.

The effects of combined oral contraceptives (OC), depot medroxyprogesterone acetate injections (DMPA), levonorgestrel subdermal implant (Norplant), copper-containing intrauterine devices (copper IUD), and Chinese stainless steel ring IUD on hemoglobin and ferritin were studied in 18-40-year-old, nonpregnant, and nonlactating women in seven countries (Bangladesh, Chile, China, the Dominican Republic, Pakistan, Thailand, and Tunisia). Data from 2507 women were analyzed. The study had a cross-sectional component in which 1295 current users of the contraceptive methods were compared with 1212 women initiating use of contraceptives. The results of this component showed that the current users of hormonal contraceptive methods generally had higher hemoglobin and ferritin levels than the noncontraceptors. The differences between women using hormonal contraceptive and noncontraceptors in mean values for hemoglobin varied between 3 and 6 g/L and for ferritin between 2 and 18 g/L. The current users of copper IUD had higher hemoglobin levels (difference in mean levels of 3 g/L), but lower ferritin levels (difference of 10 g/L) than noncontraceptors. Current use of the stainless steel ring had an adverse effect on both hemoglobin and ferritin. In a longitudinal component of the study, 285 anemic women (hemoglobin between 80 and 120 g/L at the time of initiation of contraception)--a subgroup of the cross-sectional component--were followed-up at 3, 6, and 12 months after initiation. In this component, significant mean increases of hemoglobin at 12 months were observed among the users of oral contraceptives and DMPA, but not among users of copper or stainless steel ring IUD. It is concluded that hemoglobin and ferritin levels are influenced by the use of contraceptives and that the hormonal contraceptives included in the present study have a beneficial effect on these parameters. The effects of copper IUD on hemoglobin and ferritin should be studied further.

Adolescent↗
PubMed1993

Pilot trial of a gonadotropin hormone agonist with replacement hormones as a prototype contraceptive to prevent breast cancer.

Combination oral contraceptive (COC) users have reduced risks of ovarian and endometrial cancer, but COCs have not reduced breast cancer risk. We have previously argued that a hormonal contraceptive with substantially lower doses of sex-steroids should reduce breast cancer risk by decreasing the breast epithelial cell proliferation below usual premenopausal levels. We report here the preliminary results of a pilot trial with such a prototype contraceptive consisting of an agonist of gonadotropin releasing hormone (GnRHA) administered with low doses of an oral estrogen (0.625 mg of conjugated estrogen, CE, for 6 days every week) and intermittent oral progestogen (10 mg of medroxyprogesterone acetate, MPA, for 13 days every 4 months). Eighteen subjects at five-fold or greater increased breast cancer risk were entered and randomized -12 to the contraceptive arm and 6 to a control arm. The principal endpoints included tolerance of the regimen, vaginal bleeding patterns, and the regimen's effect on the endometrium, bone metabolism, and lipids. A symptom questionnaire was used to assess tolerance; the contraceptive subjects had fewer symptoms following initiation of the regimen. This results from the elimination of symptoms associated with the luteal phase of the menstrual cycle, commonly referred to collectively as premenstrual syndrome, PMS. The few occurrences of hot flushes or vaginal dryness that did occur were eliminated by small increases in estrogen dose (0.9 mg CE). Scheduled vaginal bleeding occurred associated with most periods of progestogen administration. Unscheduled bleeding or spotting was infrequent and decreased with time on the regimen. A beneficial rise in high-density lipoprotein cholesterol was evident in the contraceptive subjects. Despite the use of an estrogen dose which is known to prevent loss of bone mineral density in normal postmenopausal women, an annualized loss of 1.9% was seen in contraceptive subjects. It is hypothesized that this is secondary to inhibition of ovarian androgen production by the GnRHA, which may additionally account for changes in libido occasionally reported with GnRHA. The study continues with the addition of a small dose of androgen to replace that lost by the action of the GnRHA.

Adult↗
PubMed1996

Smoking and cycle control among oral contraceptive users.

OBJECTIVE: Because cigarette smoking has a variety of antiestrogenic actions, we investigated the possibility that smoking may adversely affect spotting and bleeding among women using oral contraceptives. STUDY DESIGN: Three open-label, randomized clinical trials involving 16,506 cycles among 2956 oral contraceptive users were performed. RESULTS: Smokers reported a consistently higher frequency of spotting or bleeding than did nonsmokers. After recency and consistency of oral contraceptive use and progestin component were controlled for, smokers were, on average, 47% more likely to have spotting or bleeding than nonsmokers were over six cycles of oral contraceptive use, with higher levels of smoking associated with a greater frequency of spotting or bleeding. By the sixth cycle women who smoked > or = 16 cigarettes per day were almost three times more likely to have spotting or bleeding than were nonsmokers. CONCLUSION: Cigarette smoking adversely affects cycle control among oral contraceptive users, possibly by increasing estrogen catabolism. Although these findings also raise the possibility that oral contraceptive efficacy may also be impaired in smokers, an immediate concern is that oral contraceptive users who have spotting and bleeding are more likely to discontinue their use, placing them at risk of unintended pregnancy.

Adolescent↗
PubMed1998

Bias versus causality: interpreting recent evidence of oral contraceptive studies.

Late in 1995 and early 1996, 4 epidemiologic studies were published that resulted in a crude mean weighted relative risk of approximately 2 when third-generation oral contraceptives were compared with second-generation oral contraceptives as risk factors for venous thromboembolism. This article reviews empirical evidence on bias or systematic error that may have influenced the estimates of association. The Bradford-Hill criteria to distinguish causality from an observed association were used to consider whether third-generation oral contraceptives cause an apparent excess in the occurrence of venous thromboembolism. Bias is more likely than a causal relationship to explain the associations observed for venous thromboembolism. For myocardial infarction, bias may mask the full benefit of third-generation oral contraceptives. For stroke, the question of causality is moot because statistically significant differences between third- and second-generation products have not been detected. The clinical importance and the public health significance of any differences among the various products with respect to adverse cardiovascular outcomes are trivial and undetectable because of the extremely low incidence of those disorders among users of oral contraceptives. The oral contraceptive pill is 99.9% effective when used correctly. All oral contraceptives on the market are safe and getting safer.

Bias↗
PubMed1996

Contraceptive use and attitudes in Italy 1993.

Surveys conducted between 1979 and 1991 indicated that contraceptive practice in Italy underwent rapid changes over that period. In order to assess current contraceptive use and attitudes, a survey was conducted among a random sample of 2000 Italian women aged 15-45 years. Replies were received from 1542 women (77.1%). Of the self-defined non-sterile, sexually active women who wished to avoid pregnancy, 30.3% were using oral contraceptives, 8.1% an intrauterine device, and 1.1% sterilization, while 29.6% were using traditional methods, principally coitus interruptus. In reply to questions about the relative advantages and disadvantages of various contraceptive methods, women expressed worries with respect to the safety of oral contraceptives, intrauterine devices and sterilization. Relatively high percentages of women answered 'do not know' with respect to the various aspects of intrauterine devices, periodic abstinence and sterilization that were investigated. In view of the findings of previous studies, the current data obtained suggested that traditional methods are being gradually displaced by modern methods in Italy. Nevertheless, the use of traditional contraceptive is widespread, the same probably being true of inconsistent use of condoms. Furthermore, lack of information on the contraceptive options available seems to be a central issue in Italy.

Adolescent↗
PubMed1982

The influence of oral contraceptives on the metabolism of methaqualone in man.

1 Oral contraceptives were shown to suppress the mid-cycle increase in methaqualone metabolism observed in premenopausal women not receiving oral contraceptive therapy. No women were identified in whom this suppression was not observed. 2 Combined oestrogen-progestogen contraceptives produced the effect in all nine women studied. The effect was also observed in one woman who was receiving progestogen-only contraceptives. 3 The effect of the combined contraceptives was observed within one month of the commencement of the contraceptive therapy. 4 The results emphasise the need to monitor the effect of the menstrual cycle in women not receiving oral contraceptive therapy when the effects of such therapy is studied. 5 These effects are more likely to be the consequence of an inhibition of hormonal control of hepatic metabolic activity by the synthetic steroids than they are to simple inhibition of hepatic metabolism.

Adult↗
PubMed1999

Knowledge of emergency contraception amongst female patients attending a department of genitourinary medicine.

The aim of the study was to assess the knowledge of emergency contraception amongst new female patients attending an inner-city department of genitourinary medicine. Information was also sought about use of regular contraception and demography. Three hundred and ninety nine questionnaires were suitable for analysis. Half of the sample answered that the latest a woman could take emergency contraception after unprotected sex was three days. None of the sample knew that emergency contraception could be obtained up to five days. Twenty nine per cent of the sample reported sex without contraception during the menstrual cycle preceding attendance. Women who had ever used regular contraception in the past were statistically less likely to have reported unprotected sex in the menstrual cycle preceding attendance (p=0.0000068). Professional women were statistically less likely to have reported unprotected sex in the menstrual cycle preceding the clinic visit. Fourteen per cent of the sample had genital warts at this first clinic visit, 10 per cent had Chlamydia trachomatis, seven per cent had herpes simplex infection, six per cent had gonococcal infection and five per cent had trichomonal infection. Women who reported unprotected sex during the preceding menstrual cycle were not statistically more likely to have a sexually transmitted infection at this first clinic visit. A large number of women attending departments of genitourinary medicine are at risk of both pregnancy and also sexually transmitted infection. Staff working in all areas of sexual health need to have a good knowledge of both contraception and sexually transmitted infections in order to educate the clients on both aspects of unprotected sex.

Adolescent↗
PubMedDate not supplied

Impact of social marketing on contraceptive prevalence and cost in Honduras.

In 1984, the Honduran Family Planning Association launched a contraceptive social marketing program by introducing the oral contraceptive, Perla. This report examines the impact of the program on overall oral contraceptive use, use by particular subgroups, source of supply, and costs. Although use of oral contraceptives increased only slightly over the period 1984-87 (from 12.7 percent to 13.4 percent among women in union aged 15-44), the social marketing program significantly increased its share of the oral contraceptive market (from 7 percent in 1984 to 15 percent in 1987, and from 20 percent to 40 percent of sales at pharmacies). For the Honduran Family Planning Association to have realized cost savings as a result of clients switching from community-based distribution programs and commercial supply sources to contraceptive social marketing programs, the association would have had to reallocate its resources. Instead, the number of distributors in the community-based distribution program increased, while the amount of couple-years of protection from oral contraceptives decreased.

Adolescent↗
PubMed1993

Oral contraceptive use and cigarette smoking in Crohn's disease.

Previous studies have consistently found strong positive associations between smoking and Crohn's disease. The association between oral contraceptive use and Crohn's disease remains, however, controversial. In order to analyze whether smoking and oral contraceptive use are independent risk factors, a case-control study was performed. In 90 women with Crohn's disease and 90 community controls information was assessed about their smoking habits and their use of oral contraceptives. Smoking and oral contraceptive use were associated with one another. After adjusting for oral contraceptive use, the relative risk for smokers compared with nonsmokers was 3.0 (1.3-6.8). After controlling for smoking, the relative risk estimates for oral contraceptive use were for no use, 1-3 years, and > 3 years of use 1.0, 2.5 (1.0-6.6), and 4.3 (1.3-14.4), respectively. When oral contraceptive use was stratified by smoking habits, the data show that oral contraceptives only increased the risk for Crohn's disease in nonsmokers. From the lack of increase in risk for combined exposure, it is concluded that both factors might act through a common mechanism.

Adult↗
PubMed1992

Bringing parents into school clinics: parent attitudes toward school clinics and contraception.

Prior to implementing a change in school clinic policy to allow dispensing of contraceptives, parents of school-based clinic (SBC) enrollees were surveyed regarding attitudes toward clinic quality of care, desired services, and contraceptive distribution. Telephone interviews were conducted with a systematic sample of 262 parents who normally are in charge of the adolescent's health care. Parental opinion was felt to be crucial in shaping Baltimore SBC contraception policy. Parents overwhelmingly endorsed current clinic services including family planning for sexually active teens, annual physicals, and drug and alcohol counseling. Most parents rated the SBC as excellent (25%) or very good (36%), although a substantial minority found it difficult to rate the clinics (27%, "don't know"). Parents with prior verbal contact (45%) were more likely to rate the clinic as excellent (35% versus 16%) and less likely to respond "don't know" (13% versus 38%, p less than 0.001). Parent attitudes toward contraception was context specific: 63% endorsed and 27-30% opposed prescribing and dispensing. If a boy (or girl) was already having sex, 76% (or 75%) of parents supported and 14% (or 17%) opposed providing birth control pills or condoms. With parental permission, 93% supported contraception and only 3% were opposed. No differences were found by age, race, gender, or grade of student. Prior verbal communication with the clinic did not affect parent attitudes toward contraception. Consideration of parent attitudes was critical to changing SBC contraceptive dispensing policy in Baltimore. Contraceptive distribution, after counseling and necessary medical care, was initiated in September 1990. The parent and community response has been very supportive.

Adolescent↗
PubMed2006

Contraception after medical abortion.

OBJECTIVES: This study's objectives were to examine current evidence on contraception after abortion and to formulate guidelines for the use of different contraceptives after medical abortion based on current evidence. METHODS: This study was based on review of published literature and guidelines on postabortion use of contraception. RESULTS: Contraception needs to be initiated early following a first-trimester abortion. Postabortion family planning is an integral part of comprehensive abortion care. Concurrent contraception with surgical abortion has been found to be practical and effective, with high contraception usage following abortion. Most methods can be safely used following medical abortion and can be initiated either on the day of misoprostol administration (oral pills, condoms and injectable contraceptives) or after the next menstrual cycle (intrauterine device and sterilization). CONCLUSION: With proper precautions, almost all contraceptive methods can be effectively used following medical abortion.

Abortion, Induced↗
PubMedDate not supplied

Current issues in emergency contraception: an overview for providers.

Emergency contraception has the potential to greatly reduce the number of unintended pregnancies occurring each year in the United States. Emergency contraception is a safe and effective intervention to which all women should have easy access in the event of an act of unprotected intercourse. Methods of emergency contraception include combined hormone oral contraceptive pills, progestin-only oral contraceptive pills, a dedicated progestin-only emergency contraceptive product, and insertion of a copper intrauterine device. Barriers exist to the increased use of emergency contraception, including the prescription-only status of all of the methods and lack of accurate knowledge on the part of health care providers and consumers. This article provides an overview of the clinical management of emergency contraception.

Contraception↗
PubMed1999

The use of nonhormonal methods of contraception in adolescents.

Although the 1990s have seen a reduction in unintended pregnancy rates and improved contraceptive-use rates, the negative consequences of unintended pregnancy and STD acquisition continue to plague our youth. Primary health care providers, including pediatricians, play an essential role in further reducing unintended teen pregnancy and STD acquisition rates through the promotion of effective and consistent contraception. Pediatricians need to be aware that now, more than ever, nonhormonal contraceptive methods should be used by every sexually active youth, and counseling of both boys and girls should be routine. Although not as effective at preventing pregnancy as hormonal methods of contraception, many nonhormonal methods provide excellent STD protection. Condoms plus spermicide continue to be a very popular and effective method of pregnancy and STD prevention. The newer polyurethane male and female condoms provide alternative, safe barrier protection, although their efficacy at preventing HIV in vivo needs further study. Diaphragms and cervical caps, in conjunction with spermicide, also provide pregnancy and STD prevention, but not as effectively as male condoms plus spermicide. Although most likely to use condoms in association with another birth control method, adolescents often find dual-method use cumbersome and difficult to comply with. Finally, although IUDs and periodic abstinence are safe methods of birth control for older women in monogamous relationships, they are unlikely to be appropriate for most adolescents. In many respects, we have come full circle back to our "nonhormonal contraceptive roots." As we enter the twenty-first century, we have found that no single "miracle" approach can be used to reduce adolescent pregnancy and STD rates. Rather, pediatricians are obliged to offer nonhormonal methods of contraception, often in conjunction with other birth control methods, as a means of preventing unwanted STDs and pregnancy. Through a comprehensive community approach that uses sex education, abstinence programs, condom-availability programs, and contraceptive-skills training, however, pediatricians can play a central role in the promotion of effective and consistent contraception by adolescents.

Adolescent↗
PubMed2000

Oral contraceptive use and glucose metabolism in a national sample of women in the united states.

OBJECTIVE: This study was undertaken to determine whether users of oral contraceptives in a nationally representative population of US women had elevated levels of measures of glucose metabolism. STUDY DESIGN: Cross-sectional data from the Third National Health and Nutrition Examination Survey (1988-1994) included hemoglobin A(1c) levels and fasting glucose, insulin, and C-peptide levels. Means were compared among those who had never used oral contraceptives, current users of oral contraceptives, and former users of oral contraceptives, with and without adjustment for potential confounders. RESULTS: The vast majority of current users of oral contraceptives were using low-dose estrogen formulations. The two most common preparations were a triphasic formulation containing 0. 035 mg ethinyl estradiol and 0.5, 0.75, and 1 mg norethindrone (23. 9%) and a monophasic formulation containing 0.035 ethinyl estradiol and 1 mg norethindrone (20.7%). Current users of oral contraceptives did not have elevated values for any of the four measures of glucose metabolism. Hemoglobin A(1c) level and fasting glucose, insulin, and C-peptide levels were not related to duration of current use, age at which use began, or major formulation type. Among women who were former users of oral contraceptives there was no evidence of higher values among those who had recently ceased use. CONCLUSION: Oral contraceptive formulations currently available in the United States are not associated with an adverse glucose metabolic profile.

Adult↗