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PubMed1989

A multicenter clinical evaluation of a new monophasic combination: Minulet (gestodene and ethinyl estradiol).

The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.

Adolescent↗
PubMed1997

Attitudes of female college students toward over-the-counter availability of oral contraceptives.

STUDY OBJECTIVE: To determine female college students' beliefs about oral contraceptive pill (OCP) availability and use, and to examine significant factors associated with these beliefs. DESIGN: Cross-sectional survey. SETTING: Urban women's liberal arts college. PARTICIPANTS: Two hundred ninety female undergraduates who completed surveys. INTERVENTION: An anonymous survey was placed in all undergraduate mailboxes. Surveys were returned to a locked collection box in the mailroom. Within 4 weeks after distribution. 290 surveys were completed. MAIN OUTCOME MEASURES: Sexual and contraceptive practices and students' beliefs regarding whether OCPs should be made available without prescription. RESULTS: The respondents' average age was 20.9 +/- 3.3 years; 84% reported previous sexual intercourse with the mean age of first intercourse at 16.6 +/- 2.2 years. Seventy-five percent of the sexually active women reported use of OCPs and 52% had used OCPs at their last intercourse. Sixty-five percent of all respondents felt OCPs should not be available without prescription. The two most commonly cited reasons for not wanting OCPs to be available over the counter (OTC) were that (1) side effects might occur that a health care provider could have prevented (59%), and (2) people would not go to their providers for regular check ups (56%). The most commonly cited reason for believing that OCPs should be available OTC was that there would be fewer unwanted pregnancies (74%). Race, previous OCP use, previous sexual activity, and perceived risk of pregnancy were not significant predictors of believing OCPs should be available OTC. Having had a previous pregnancy was a significant predictor of believing OCPs should be available OTC (p = 0.047). Those who believed OCPs should be available only with a prescription were willing to pay more for OCPs (p = 0.033). Logistic regression controlling for race revealed that both younger age (p = 0.03) and previous pregnancy (p = 0.002) were independent predictors of believing OCPs should be available OTC. CONCLUSIONS: The majority of our sample believe that OCPs should remain as a prescription medication. Previous pregnancy and younger age are important factors in determining beliefs regarding OCP availability. Further studies in a more diverse population are needed to explore the relationship between age, previous pregnancy, and desire for contraceptive availability without prescription.

Adolescent↗
PubMed2002

Magnetic resonance imaging to determine the distribution of a vaginal gel: before, during, and after both simulated and real intercourse.

To provide effective contraception and protection against sexually transmitted disease, vaginal gels should maximally cover the cervical os and the vaginal epithelium before, during and after intercourse. To non-invasively monitor the intravaginal distribution of an applied intravaginal gel, we performed high-resolution magnetic resonance imaging (MRI) of the female pelvis before, during and after both real and simulated sexual intercourse. We sought to determine whether simulated intercourse with a plastic phallus could be used as a surrogate for real intercourse for such experiments. Dilute gadolinium chelate solution was mixed with Gynol-II gel and introduced intravaginally to volunteer female human subjects using a conventional applicator. MRI was performed at 1.5 Tesla with a surface coil. Imaging of the female pelvis was performed: (1) immediately after insertion of the gel; (2) during real intercourse with a male partner (2 subjects) or simulated intercourse with a plastic phallus (4 subjects); and (3) after completion of real or simulated intercourse. Subjects were studied after application of both 3 mL and 5 mL of vaginal gel. Measurements of gel thickness covering the vaginal mucosa were made digitally using electronic calipers. The bolus of gel is initially located in the upper vaginal canal, superior to the urogenital diaphragm. Both real and simulated intercourse dramatically increases the spread of gel to the lower vagina. The cervix appears to be adequately covered with gel both before and after intercourse. Increasing the volume of the gel increases initial vaginal mucosal coverage but also increases leakage from the introitus. No statistically significant differences in vaginal mucosal coverage were found between patients having undergone real vs. simulated intercourse, or on post-intercourse scans of 3 mL versus 5 mL. MRI is a sensitive, reproducible means of tracking the spread of intravaginal medications.

Administration, Intravaginal↗
PubMedDate not supplied

Family planning clinic services in the United States: patterns and trends in the late 1990s.

CONTEXT: Publicly funded family planning clinics are a vital source of contraceptive and reproductive health care for millions of U.S. women. It is important periodically to assess the number and type of clinics and the number of contraceptive clients they serve. METHODS: Service data were requested for agencies and clinics providing publicly funded family planning services in the United States in 1997. The numbers of agencies, clinics and female contraceptive clients were tabulated according to various characteristics and were compared with similar data for 1994. Finally, county data were tabulated according to the presence of family planning clinics and private physicians likely to provide family planning care and according to the number of female contraceptive clients served compared with the number of women needing publicly funded care. RESULTS: In 1997, 3,117 agencies offered publicly funded contraceptive services at 7,206 clinic sites. Forty percent of clinics were run by health departments, 21% by community health centers, 13% by Planned Parenthood affiliates and 26% by hospitals or other agencies. Overall, 59% of clinics received Title X funding. Agencies operated an average of 2.3 clinics, and clinics served an average of 910 contraceptive clients per year. Altogether, clinics provided contraceptive services to 6.6 million women-approximately two of every five women estimated to need publicly funded contraceptive care. The total number of providers and the total number of women served remained stable between 1994 and 1997; at the local level, however, clinic turnover was high. Some 85% of all US counties had one or more publicly funded family planning clinics; 36% had one or more clinics, but no private obstetrician-gynecologist. CONCLUSIONS: Publicly funded family planning clinics are distributed widely throughout the United States and continue to provide contraceptive care to millions of US women. Clinics are sometimes the only source of specialized family planning care available to women in rural counties. However, the high rate of clinic tumover and the lack of significant growth in clinic numbers suggest that limited funding and rising costs have hindered the further expansion and outreach of the clinic network to new geographic areas and hard-to-reach populations.

Adolescent↗
PubMed1991

[Use of contraception among women applying for abortion].

During a period of one year (1988-89), a questionnaire was distributed to women applying for legal abortion at Frederikssund Hospital in Denmark. Two hundred and eight-eight answered the questions about why they had become pregnant. 84% of the women had used contraceptive methods. The remainder included women who regretted a planned pregnancy and women who believed they were infertile. 50% of the women had at least one intercourse without using contraceptives. Women using barrier-methods who forgot the contraceptive once or women who had stopped using the pill were mainly concerned. 23% of the women said they had used contraceptives correctly and consistently. After the abortions 75% intended to use IUD, oral contraceptives or sterilization. Suggestions to reduce the number of unwanted pregnancies are discussed. Eg. spread of the knowledge of postcoital contraception as an extraordinary measure after an unprotected coitus is suggested. This will not replace other contraceptives, but should be used in a emergency.

Abortion Applicants↗
PubMedDate not supplied

Educational needs of adults with congenital heart disease.

Adults with congenital heart disease represent a new and growing population of patients who pose a challenge to both medicine and nursing. The purpose of this study was to identify the educational needs of adults with congenital heart disease. The study used a prospective, cross-sectional, case-control study design and enrolled 124 adults with congenital heart disease and 124 matched healthy controls. Adults with congenital heart disease were more likely to report living at home with parents and less likely to be employed compared with healthy controls. When those adults with acyanotic and cyanotic congenital heart disease were compared, acyanotic adults were twice as likely to be employed. Additionally, several areas of educational needs were identified in this study for adults with congenital heart disease.

Adult↗
PubMed2000

Breast carcinoma etiology: current knowledge and new insights into the effects of reproductive and hormonal risk factors in black and white populations.

BACKGROUND: A crossover in breast carcinoma incidence at ages 45-49 years has been observed between black and white women, with blacks experiencing higher incidence at younger ages and lower incidence after age 50 years. Can this phenomenon be partially explained by the differences in the distributions of reproductive risk factors? This article focuses on the effects and distributions of age at first full term pregnancy (FFTP), parity, and oral contraceptive (OC) use in younger versus older and black and white populations. Effects of hormone replacement therapy (HRT) are also summarized. METHODS: A literature review was conducted and information integrated on the effects and distributions of reproductive and hormonal risk factors in black and white populations, the crossover effect of parity, and the Pike model of "breast tissue age." RESULTS: Overall, early age at FFTP and higher parity decreased risk for both races. Distributions of age at FFTP and parity varied widely between the two races. Based on the effects and distributions of age at FFTP and parity, the authors formulated the hypothesis that a crossover in incidence curves between the two races would be expected, rather than be considered an anomaly. Regarding OC use, generally a stronger increase in risk was observed for younger women than for older women. Regarding HRT, a recent meta-analysis observed an increased risk of 1.35 for 5 years of use or more. CONCLUSIONS: To promote public health in diverse populations, and to provide further insight into breast carcinoma etiology, research needs to focus on multicultural differences and similarities in the relation of hormonal risk factors and breast carcinoma.

Black or African American↗
PubMed2003

Recurrent episodes of skin angioedema and severe attacks of abdominal pain induced by oral contraceptives or hormone replacement therapy.

PURPOSE: Recurrent angioedema, characterized by skin swelling, colicky attacks of abdominal pain, and life-threatening laryngeal edema, can be either hereditary or acquired. According to anecdotal reports, it may be associated with use of oral contraceptives and hormone replacement therapy. We investigated potential interactions between these medications and various types of recurrent angioedema in a large cohort of women. METHODS: Women with recurrent angioedema (n = 516) underwent a thorough medical evaluation. They were then classified by type of angioedema, using standard criteria. RESULTS: Of the 516 women, 228 (44%) had used oral contraceptives or hormone replacement therapy, including 103 (45%) with urticaria-related angioedema, 50 (22%) with idiopathic angioedema, 39 (17%) with hereditary angioedema type III, 32 (14%) with hereditary angioedema type I, and 4 (2%) with angioedema induced by angiotensin-converting enzyme inhibitors. Oral contraceptives or hormone replacement therapy led to angioedema attacks in 46 women (20%), including 20 (63%) of the women with hereditary angioedema type I, 24 (62%) of those with hereditary angioedema type III, and 2 (4%) of those with idiopathic angioedema. These 46 women included 26 in whom symptoms occurred for the first time after use of these medications and 20 in whom pre-existing recurrent angioedema worsened considerably. CONCLUSION: Oral contraceptives or hormone replacement therapy can either induce or exacerbate symptoms of hereditary angioedema type I or type III, or idiopathic angioedema. However, many women with these diseases tolerate these medications without having any effects on their angioedema.

Abdominal Pain↗
PubMed1991

Oral contraceptives and neoplasia of the uterine corpus.

Effects of oral contraception on neoplasia of the uterine corpus are reviewed on the basis of epidemiologic studies reported to date. A duration-related protective effect against endometrial cancer occurs from use of combined oral contraceptives, those in which each active pill contains both estrogen and progestogen. The risk before age 60 years is reduced by about 38% with two years of use; use of combined OCs for 4, 8, and 12 years, respectively, confers an estimated 51%, 64%, and 70% reduction in endometrial cancer risk. The protective effect appears not to be diminished by discontinued use, even 15 or more years after stopping. Whether protection continues throughout the entire postmenopausal period, even in the presence of long-term hormone replacement therapy, remains to be seen. Use of combined OCs may protect against uterine leiomyomas ("fibroids"), but the evidence is not conclusive. The few findings about effects of oral contraception on the risk of adenomatous hyperplasia are of uncertain validity. Only one study, with few patients, has considered oral contraception in relation to uterine sarcomas.

Contraceptives, Oral↗
PubMed1984

The use of cervical caps at the University of California, Berkeley: a survey.

A survey of cap use and efficacy of women who initially purchased a cervical cap at the University of California at Berkeley Student Health Service is described. It reports the follow-up of 65 U.C. women students who purchased either Vimule or Cavity-rim cervical caps from May, 1978 through June, 1981 and raises questions about cervical cap use and efficacy. Participants were divided into two groups: regular and irregular users. Of the 33 regular users, 16 experienced unplanned pregnancy during the study. Survival probabilities were 80% at 6 months, 73% at one year and 52% after 2 years. Life table analysis of the 33 regular users indicated a 20% probability of pregnancy in the first 6 months of use, 27% by 1 year and 48% by the end of 2 years.

Adolescent↗
PubMed2000

No sex-related differences but significant inhibition by oral contraceptives of CYP2C19 activity as measured by the probe drugs mephenytoin and omeprazole in healthy Swedish white subjects.

BACKGROUND: Although it is known that the use of oral contraceptives inhibits oxidative drug metabolism, there is little information regarding their effect on CYP2C19 activity. Moreover, earlier reports suggest that there may be differences in CYP2C19 activity between men and women. OBJECTIVE: We sought to assess the effect of sex and intake of oral contraceptives on CYP2C19 activity as measured by the probe drugs mephenytoin and omeprazole. METHODS: To determine CYP2C19 activity in white Swedish subjects, 644 subjects previously phenotyped with mephenytoin and 175 subjects phenotyped with omeprazole were investigated. The 8-hour urinary mephenytoin S/R ratio after ingestion of 100 mg mephenytoin and the plasma concentration ratio of omeprazole/hydroxyomeprazole at 3 hours after ingestion of 20 mg omeprazole were used as measures of CYP2C19 activity. Differences in these ratios and in their frequency distributions were then examined among women with and without oral contraceptives and men. In addition, nearly all subjects in the omeprazole group had been genotyped with regard to the CYP2C19*2 (ml) allele. Subjects homozygous for the CYP2C19*2 allele were excluded from the study. RESULTS: The median mephenytoin S/R ratio was 2.5-fold higher in the subgroup of women taking oral contraceptives compared with either women not taking oral contraceptives (P < .001) or men (P < .001). Similarly, the mean omeprazole/hydroxyomeprazole ratio was twice as high in the oral contraceptive group compared with women not taking oral contraceptives (P < .001) or men (P < .001). However, no differences were evident between women not taking oral contraceptives and men in either the mephenytoin group (P = .48) or the omeprazole group (P = .77). The oral contraceptive-induced inhibitory effect on CYP2C19 activity was similar between the CYP2C19*1/*1 and *1/*2 genotypes, and they were independent of age. CONCLUSIONS: Intake of oral contraceptives significantly inhibits CYP2C19 activity, but there is no true sex-related difference in CYP2C19 activity in healthy, white, Swedish subjects.

Adolescent↗
PubMed2004

Combination estrogen-progestin contraceptives and body weight: systematic review of randomized controlled trials.

OBJECTIVE: Many women and clinicians believe that combination estrogen-progestin contraceptive use can lead to weight gain. This concern can deter women from starting hormonal contraception or lead to premature quitting. This review evaluated the association between combination contraceptive use and change in body weight. DATA SOURCES: The computerized databases CENTRAL, MEDLINE, EMBASE, Popline, and LILACS (from their inception to 2002) were used to conduct this review. Known investigators and manufacturers were contacted for information about other trials not discovered in the database search. METHODS OF STUDY SELECTION: All English-language, randomized controlled trials measuring weight change that were at least 3 treatment cycles in duration and that compared a combination contraceptive to a placebo or to a combination contraceptive that differed in drug, dosage, regimen, or study length were eligible for inclusion. Of the 570 reports of randomized controlled trials of eligible interventions that were identified, 42 trials were included in the systematic review. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently abstracted data from the eligible trials using a standard form. Depending on the data available, the weighted mean difference using a fixed effect model with 95% confidence intervals was calculated for the mean change in weight between baseline and posttreatment measurements or the Peto odds ratio with 95% confidence intervals was calculated by using the proportion of women who gained or lost more than a specified amount of weight. The 3 placebo-controlled, randomized trials did not find evidence supporting a causal association between combination oral contraceptives or a combination skin patch and weight gain. Most comparisons from the 40 trials that compared 2 or more combination contraceptives showed no substantial difference in weight. In addition, discontinuation of combination contraceptives because of weight gain did not differ between groups when this factor was studied. CONCLUSION: Available evidence is insufficient to determine the effect of combination contraceptives on weight, but no large effect is evident.

Adult↗
PubMed1985

Are there adverse effects of periconceptional spermicide use?

Recent studies have suggested that spermicide exposure around conception may cause congenital malformations, reduced birth weight, or spontaneous abortion. This large, prospective study examined the risk for multiple malformation, patterns of malformations, low birth weight, preterm delivery, and spontaneous abortion in infants whose mothers used spermicides only before or after their last menstrual period, compared with a control group using other contraceptive methods. The multiple malformation rates in women using spermicides only before or after their last menstrual period were 3.8 and 4.8 per thousand, respectively. For the control groups, the corresponding rates were 5.4 and 6.4 (not significant). No pattern of malformations was found in spermicide-exposed infants. The risk of preterm delivery, the risk for producing a low-birth-weight (less than 2500 gm) infant, and the risk of spontaneous abortion were no higher in women exposed to spermicides than in women using other methods of contraception. This study finds no evidence that spermicide exposure around the time of conception is dangerous to the fetus.

Abnormalities, Drug-Induced↗
PubMed1991

Postponement of withdrawal bleeding with a monophasic oral contraceptive containing desogestrel and ethinylestradiol.

This study investigated the ability of a monophasic sub-50 oral contraceptive, containing desogestrel and ethinylestradiol, to postpone withdrawal bleeding in normal healthy women. In the analyzed group of 105 regular users of Marvelon, about 75% did not experience any vaginal bleeding during the 21 days of postponement. A 95% confidence interval was calculated which suggests that the percentage of women able to postpone their withdrawal bleeding successfully for 19 days ranges between 67.0% and 83.5%. Women with no vaginal blood loss in the postponement period were more willing to try this method of postponement again, compared to women who experienced vaginal blood loss in the postponement period. This difference was statistically significant. Nevertheless, the majority of women with vaginal blood loss were also willing to try this method again if necessary. The study results suggest that Marvelon offers an effective and acceptable method of postponing withdrawal bleeding for three weeks for most regular users of this contraceptive.

Adolescent↗
PubMed2001

The naturalness of the artificial and our concepts of health, disease and medicine.

This article isolates ten prepositions, which constitute the undercurrent paradigm of contemporary discourse of health disease and medicine. Discussion of the interrelationship between those prepositions leads to a systematic refutation of this paradigm. An alternative set is being forwarded. The key notions of the existing paradigm are that health is the natural condition of humankind and that disease is a deviance from that nature. Natural things are harmonious and healthy while human made artifacts are coercive interference with natural balance. It is suggested that the current paradigm is influenced by the world of finances and by instrumental reason. The alternative model suggests that human nature cannot be delineated. Humans fashion their own selves and nature by artificial means, medicine among them. The article discusses the implications of the paradigm adapted in various scholarly and popular debates such as the use of sex hormones for contraception, the care of the elderly, holistic medicine and distributive justice in health care. Medicine is not an isolated or a privileged realm. There is no unique entitlement to healthcare. It is always part of a broader agenda of social values and institutions. A open view of human societies, values and practices as they are situated within concrete material conditions is the platform required for an integrative and creative discourse of health care.

Disease↗
PubMed1983

Imipramine serum protein binding in healthy subjects.

Imipramine serum protein binding was measured by equilibrium dialysis in healthy subjects (88 women and 57 men; age 21 to 79 yr) who were relatively evenly distributed according to age, sex, smoking habits, and oral contraceptive use. Average free fraction was 10.9 +/- 1.4%. Interindividual variation in degree of binding was less than 100%, the free fraction varying from 8% to 14.7%. Women age 30 to 39 yr had significantly lower binding than all other female age groups and lower binding than men age 30 to 39 yr. Oral contraceptive use and smoking habits did not correlate to degree of binding. Serum concentrations of 12 proteins were measured in subjects with the highest binding (n = 17) and lower binding (n = 18). The concentration of orosomucoid, complement C3c, and apolipoprotein B was higher in the high-binding group than in the low-binding group. Since covariation among concentrations of these three proteins was modest, the data indicate a separate significance of the three proteins. The binding of 3H-imipramine did not correlate with the albumin concentration.

Adult↗
PubMed1988

Candida concentrations in the vagina and their association with signs and symptoms of vaginal candidosis.

Among 106 women harbouring yeasts in the vagina and with other causes of genital pathology excluded, there was a statistically significant association between numbers of yeasts recovered semi-quantitatively from vaginal swabs and symptoms of pruritus and signs of abnormal vaginal discharge but no association between yeast numbers and other individual symptoms or signs of vaginal candidosis, including patients' own subjective assessment of abnormal vaginal discharge. The presence of yeasts detectable by direct microscopic examination was statistically associated with pruritus, discharge and vaginitis. There was no relationship between numbers of vaginal yeasts and histories of antibiotic or oral contraceptive usage or the stage of the menstrual cycle. Distributions of Candida species and Candida albicans biotypes were not statistically related to any symptoms, signs or other factors. The results of this study suggest that vaginal pathology caused by Candida species may be related to the quantity of the fungus in the vagina and that only pruritus and objectively assessed vaginal discharge are firm clinical indicators of Candida infection.

Candida↗