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PubMed2005

Mechanistic pharmacokinetic modelling of ephedrine, norephedrine and caffeine in healthy subjects.

AIM: The combination of ephedrine and caffeine has been used in herbal products for weight loss and athletic performance-enhancement, but the pharmacokinetic profiles of these compounds have not been well characterized. This study aimed to develop a mechanistic model describing ephedrine, norephedrine, and caffeine pharmacokinetics and their interactions in healthy subjects. METHODS: The pharmacokinetic model was developed based on the simultaneous modelling using plasma samples gathered from two clinical trials. The treatments consisted of single-doses of pharmaceutical caffeine and ephedrine, given alone or together, and an herbal formulation containing both caffeine and ephedrine. We used a mixed-effect statistical model and the program NONMEM to take account of intersubject variability. RESULTS: Three hundred and seventy-nine ephedrine, 352 norephedrine, 417 caffeine plasma concentrations and 40 ephedrine urine concentrations were obtained from 24 subjects. A one-compartment model with first-order absorption described the caffeine data. Caffeine clearance was 0.083 l min(-1) (CV 38%) and decreased to 0.038 l min(-1) in presence of oral contraceptive therapy, its volume of distribution was 38.6 l (CV 20%) and its absorption rate constant was 0.064 l min(-1) (CV 50%). A four-compartment model described the pharmocokinetics of ephedrine and norephedrine. Ephedrine was eliminated mostly renally, with a clearance of 0.34 l min(-1) (CV 11%), and a volume of distribution of 181 l (CV 19%). Nonlinearity in the conversion of ephedrine to norephedrine was observed. Different models showed that the simultaneous administration of caffeine, or the amount of caffeine in the absorption compartment, was associated with a slower rate of absorption of ephedrine. A 32% greater relative bioavailability of herbal compared with pharmaceutical ephedrine administration was observed. CONCLUSIONS: We describe a mechanistic model for ephedrine, norephedrine and caffeine pharmacokinetics and their interactions. The relative bioavailability of ephedrine differed between the herbal supplement compared with the pharmaceutical formulation. Concomitant ingestion of caffeine slowed the absorption rate of ephedrine, which is mainly related to the amount of the former in the absorption compartment. A saturable process appears to be involved in the metabolism of ephedrine to norephedrine.

Administration, Oral↗
PubMed1987

Heterogeneous distribution of serum prolactin values in apparently healthy young women, and the effects of oral contraceptive medication.

Controversy over effects of oral contraceptives (OCs) on serum prolactin (PRL) levels from retrospective studies suggested performing a prospective study. Statistical analyses of PRL levels in 552 reproductive-age, nonmedicated women indicated a provisionally lognormal distribution of values less than 15 ng/ml, contaminated by a small number of abnormally high values less than or equal to 90 mg/ml. Truncated samples were used to estimate a "normal range" of PRL levels for three subsets of the study sample, classified according to number of weeks after pregnancy. Fifty-microgram estrogen-containing OCs doubled basal PRL levels at 5 to 8 weeks in those whose initial control values fell below 15 ng/ml, but the PRL elevation was no longer evident at 6 months of drug use. These OCs induced a small but significant lowering of PRL at 5 to 8 weeks in those with control levels of 15 ng/ml or higher. Thirty-five-microgram estrogen-containing OCs failed to alter PRL levels at 5 to 8 weeks in those with control values less than 15 ng/ml.

Age Factors↗
PubMed1982

IUD and salpingitis: a prospective study of pathomorphological changes in the oviducts in IUD-users.

A prospective study on pathomorphological changes in the oviducts in 253 women who underwent voluntary sterilization via posterior colpotomy performed at the Catharina Ziekenhuis, Eindhoven, was performed in order to investigate the effect of the intrauterine device (IUD). Some form of salpingitis was found in 54% of the IUD-group and in only 6% of the control group (P less than 10(-6), four-fold table, chi-squared test.) Microbiological study in 51 patients did not explain the pathoanatomical changes. As the IUD-and control-groups were comparable in all investigated parameters, the inflammatory reaction must be caused by the method of contraception.

Adult↗
PubMed1997

Ovarian volume in gynecologically healthy women using no contraception, or using IUD or oral contraception.

OBJECTIVE: The aim of this study was to determine the ovarian volume by transvaginal ultrasonography in a gynecologically healthy population of women using no contraception, using intrauterine contraceptive device, or using oral contraceptive. MATERIALS AND METHOD: The study had a cross-sectional design. The ovaries of 428 women aged 1445 who contacted the family planning clinic in the county of Funen were examined. Most of the statistical analyses were carried out using standard techniques. However polynominal regression analysis was used to model ovarian volumes as a function of the day of cycle. RESULTS: No differences between the volumes of the right and the left ovary were found in any of the groups. Significant differences were found between the ovarian volumes of the three groups. The ovarian volumes were found to be largest in women using intrauterine contraceptive device, lesser in women using no contraception and smallest in women using oral contraception. A significant difference was found of the ovarian volumes throughout the menstrual cycle in women who were not using oral contraception. The ovarian volumes did not change throughout the menstrual cycle in women using oral contraception. In women not using oral contraception the largest ovary increased in volume from the start of the cycle to day 19, thereafter the volume declined. No evidence of any change of volume over the menstrual cycle was found in the smallest ovary and, for women using oral contraception, both ovaries. There was no correlation between age, height, weight, parity, and ovarian volume in any of the groups. CONCLUSION: The ovarian volumes, in gynecologically healthy women using intrauterine contraceptive device, are larger than in women using no contraception. It appears that oral contraception reduces the volumes of both ovaries in all phases of the menstrual cycle to equal levels.

Adult↗
PubMed2002

Abortion requests among adolescents in comparison with young adults in a Swiss region (1990-1998).

AIM: To examine the recent evolution of abortion request rates among adolescents and young adults in the Canton of Vaud (Switzerland) and to describe the circumstances of the abortion requests and sociodemographic characteristics by age subgroups and nationality. METHOD: Data for women aged 14 to 24 y living in Vaud were selected from the 12,358 abortion requests from residents aged 14-49 y between 1990 and 1998. RESULTS: Overall, abortion request rates by age were stable over the study period. However, rates for non-Swiss women were two to three times higher than those for Swiss women, at 4.5 [95% confidence interval [CI]: 3.8-5.2] vs 2.4 [95% CI: 2.1-2.7] per 1000 adolescents below the age of 18, 18.1 [95% CI: 17.2-18.9] vs 8.0 [95% CI: 7.1-8.8] per 1000 women aged 18-19 and 30.5 [95% CI: 29.1-32.0] vs 10.2 [95% CI: 9.6-10.8] per 1000 women aged 20-24. The ratio of abortions to live births was greatest for women under 20 y of age. at 1.9, in comparison with the ratio observed among adult women aged 20-24 (at 0.4). The abortion rate per 1000 conceptions >6 wk remained stable; this rate was 590 per 1000 among 14-19-y-olds in 1997. CONCLUSION: The abortion request rate among youths in this Swiss region has not increased between 1990 and 1998. Efforts must be intensified to ensure universal access to family planning services and contraception, especially for young foreign women and adolescents.

Abortion Applicants↗
PubMed2004

Contraception continuation rates and reasons for discontinuation in Zahedan, Islamic Republic of Iran.

We evaluated contraception continuation rates and discontinuation reasons in Zahedan among 1741 women from 1998-2000. By Kaplan-Meier technique continuation rates were 92% for low dose combined hormonal oral contraceptives (OC), 86% for a levonorgestrel-releasing implant, 82% for intrauterine devices (IUD) and 53% for medroxyprogesterone acetate at the first year. After 3 years, continuation was 78% for levonorgestrel implant, 70% for OC, 60% for IUD and 44% for medroxyprogesterone acetate. The commonest reason for discontinuing OC and medroxyprogesterone acetate was changing method; for IUD and levonorgestrel-releasing implant, the commonest reason was side-effects. By Cox regression model, continuation rate and contraceptive type were significantly related to health centre.

Adult↗
PubMed2001

Release of progestin-only emergency contraception.

Progestin-only emergency contraception has been available in a prepackaged product since 1999. In a multicenter randomized trial, the levonorgestrel-only regimen was better tolerated and significantly more effective than the previous standard of care, the Yuzpe regimen. The levonorgestrel-only regimen prevented 85% of unintended pregnancies compared with 57% in the Yuzpe regimen. Emergency contraception is more effective the earlier the treatment begins. With the emergence of specifically prepackaged kits, emergency contraception appears to be more accessible and convenient to providers and to women. However, substantial barriers still exist to women who wish to obtain emergency contraceptive within the recommended initiation of 72 hours after unprotected intercourse. More recent information that emergency contraception is more effective the sooner it is initiated underscores the need for effective educational and distribution strategies.

Contraception↗
PubMed1998

A distribution study of CYP1A2 phenotypes among smokers and non-smokers in a cohort of healthy Caucasian volunteers.

OBJECTIVE: To analyse distributions of a urinary ratio of caffeine metabolites (MRc) representative of cytochrome P450 (CYP) 1A2 activity in a cohort of Caucasian German healthy volunteers and to re-assess the effects of smoking and oral contraceptives on the range and type of MRc distribution. METHODS: A cohort of volunteers comprising 192 individuals (96 males, 96 females) was divided into subgroups according to smoking and/or use of oral contraceptives. The CYP1A2 substrate caffeine was administered, and urine was collected for 6 h and analysed for representative caffeine metabolites. Distribution of a CYP1A2-dependent MRc was analysed using cumulative distribution (probit) plots and Rosin-Rammler-Sperling-Weibull (RRSW) functions. RESULTS: Cumulative distribution curves for males, and females, without further subgrouping for smoking habits and/or oral contraceptive steroid (OCS) consumption, showed slightly higher MRc values, i.e. slightly higher CYP1A2 activities, in males. Significantly higher MRc values were found in smokers of both sexes than in non-smokers. The distributions among female non-smokers or smokers with and without OCS were nearly super-imposible, however. For the two male subgroups, the sum of two RRSW functions resulted in a better adjustment to the data than a unimodal skewed distribution. A weak correlation between MRc and the number of cigarettes smoked per day was found. CONCLUSION: The inducing effect of smoking on CYP1A2 activity was confirmed, whereas no significant inhibitory effect of oral contraceptives was observed. The finding that the data are compatible with bimodal distributions in non-smokers suggests a significant impact of genetic factors on MRc. Among smokers, data were also compatible with bimodal distributions, i.e. with the existence of a "non-responder" phenotype concerning CYP1A2 induction by compounds present in tobacco smoke.

Adult↗
PubMed1984

The oral contraceptive PPI: its effect on patient knowledge, feelings, and behavior.

The distribution of the PPI by pharmacists is at best controversial. Although most health professionals agree that the patient has a right to receive information about drugs, they disagree on the best way to provide that information. Since the oral contraceptive PPI has been in routine use for approximately 10 years, a large data base exists that can be used to determine not only patient acceptance of the PPI, but also knowledge, feelings, and behavior secondary to the PPI. In this study, 50 women of childbearing age completed a questionnaire, and it was learned that 84 percent had taken or were currently taking oral contraceptives, and 90 percent of those received a PPI; however, only 61 percent of these women read all of it. The women performed poorly on the knowledge exam (mean +/- SD, 44.5 +/- 21.2, range, 0-83 percent); those who read all of the PPI or who were white had higher scores (p less than 0.02 and p less than 0.001, respectively). Thirty-eight percent of the women thought that the PPI information was inadequate, suggesting that it needs to be rewritten and/or supplemented with information from pharmacists. After reading the PPI, 12 percent contacted their pharmacist for additional information. Pharmacists are in a unique position to provide oral contraceptive information that enables women to make informed judgments regarding benefit:risk ratios on a personal basis.

Adult↗
PubMed1998

Men's views on male hormonal contraception-a survey of the views of attenders at a fitness centre in Bristol, UK.

The last three decades have seen a significant move in Western society away from traditional gender roles. How do these role changes extend to the area of family planning? Family planning researchers and service providers have focused almost exclusively on women. Scientific research is being undertaken to develop a hormonal contraceptive for men. Service providers should be asking the question: How will UK men respond to a reversible hormonal contraceptive method for males? The aim of the study is to begin answering this question. A descriptive survey explored the view of a sample of UK men towards a future, hormonal contraceptive method. Self-administered questionnaires were distributed through convenience sampling to 250 men. The response rate was 46 per cent (115). In terms of preference of contraceptive methods, the 'male pill' ranked third as a first choice and ranked first as the second choice. The results indicate that couples in an established relationship may be the appropriate target group for a 'male pill'. The tablet form was the preferred delivery method for a future male hormonal contraceptive. Perceived side effects were not well tolerated with 71 per cent (81) of respondents not prepared to tolerate any. The majority (94 per cent) expected health monitoring and 38 per cent of men were willing to pay between 5-10 per month. The results indicate a potential uptake of a future 'male pill', with couples in an established relationship as an appropriate target group. However, the study was based on a sample which was small and biased towards middle-class professionals. Further research is needed which covers a wider geographical area representing all social groups and includes women.

Adult↗
PubMed1979

Sexual behavior among university students in Nigera.

Sexual behavior patterns among Nigerian university students and factors influencing them were studied. While permarital cohabitation is common, a large percentage (48%) had their first coital experience between the ages of 22 and 27. Religion does not appear to have a strong inhibiting influence on premarital sex, although it does affect the frequency of changing partners. Contraceptives, although known to almost all the respondents, are not widely used. The use of contraceptives had little influence on premarital cohabitation. Oral-genital, male-male, and female-female sexual practices are very uncommon.

Adolescent↗
PubMed2001

Body piercing: lifestyle indicator or fashion accessory?

A study was undertaken to assess the prevalence of body piercing (BP) in women attending a sexually transmitted disease (STD) clinic, and any associated demographic, socioeconomic and sexual indicators. One hundred and fifty-two new female patients attending the Southampton clinic were the subjects of the study; of these 52 (32%) had BP, the most common site being the navel (25%). BP was more common in women who had their ears pierced more than once (35:71, 49%). It was less common in women who were non-smokers, being present in 17:77 (22%), and in older women, only one of 18 (6%) women aged 35 or older having had BP done. The presence of BP was not associated with socioeconomic class, method of contraception, multiple partners, or the presence of any genital infection. The study supports the suggestion that most BP is done for fashion reasons.

Adolescent↗
PubMed1996

Emergency contraceptive pills: a survey of use and experiences at College Health Centers in the mid-Atlantic United States.

The authors conducted a telephone survey to investigate the availability of the emergency contraceptive pill (ECP) at college health centers in the mid-Atlantic region of the United States. Related issues, such as distribution procedure, existence of an ECPs protocol, personnel involved, contraindications, follow-up procedures, methods of advertising, and staff attitudes were examined. Of the 124 completed responses, 43 schools (35%) reported distributing ECPs. The major reasons the schools listed for not distributing ECPs (n = 81, 65%) were inadequate staffing, religious convictions, no perceived need, and the service was available from a source in the local community.

Attitude of Health Personnel↗