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PubMed2002

Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study.

The objective of the study was to evaluate the contraceptive performance, acceptability, side effects, and adverse events of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) releasing 14 microg of LNG/day, in perimenopausal women. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss in women with or without fibroids. The study, consisting of 109 women, suggests that FibroPlant-LNG IUS is an effective contraceptive. No pregnancies occurred with the FibroPlant-LNG IUS. The total use-related discontinuation rate at 1 year is low (1.9) and results in a high rate of continuation of use (98.1). In addition, the FibroPlant-LNG IUS demonstrated a high level of effectiveness in reducing bleeding in women with excessive menstrual flow even when medium or large fibroids were present. However, an effect on the size of the fibroids could not be demonstrated. Patient satisfaction with the method is high, which is a prerequisite for continuance of the method, and may be linked with the advantageous design characteristics of the FibroPlant-LNG IUS, the virtual absence of hormonal side effects, and the low incidence of irregular bleeding and spotting even during the first 3 months after insertion of the FibroPlant IUS. Counseling remains important though to explain to women about the possible occurrence of changes in their menstrual pattern that may sometimes be annoying but harmless. It is concluded that many women over age 40 years could substantially benefit from the advantages of this intrauterine drug delivery technology which provides contraception and treatment of a possible associated condition such as menorrhagia. The treatment also creates the opportunity to pass through the transitional perimenopausal period smoothly and to benefit fully from the advantages hormone replacement therapy offers in terms of treatment of short-term symptoms and long-term prevention by gradually replacing the waning estrogens.

Adult↗
PubMed1998

[Rationale for prescribing oral contraceptives].

Strategies for prescribing oral contraceptives (OC) are explained with particular emphasis on individual conditions which can be helpful to optimize the selection process out of the numerous on the market. While contraceptive efficacy unequivocally is regarded as high additional non-contraceptive benefits become substantial criteria for an individual decision. Antiandrogenic properties of progestogens like cyproteroneacetate clearly determine their preference in the presence of unwanted clinical signs and symptoms of hyperandrogenism. In most of the non androgen-related conditions the estrogenicity of a preparation as a result of the dose of ethinylestradiol and dose as well as antiestrogenic potency of the progestogen accounts for the majority of non contraceptive effects. Different progestogens are evaluated with respect to their antiestrogenic property. It is suggested to start treatment after selection of an appropriate progestogen with the lowest daily dose of both hormonal components and to continue intake at least for 3 to 4 cycles as long as no serious adverse events occur. In cases of persisting problems i.e. bleeding irregularities doses or dosing-schemes should be altered preferentially without switching to another gestagen.

Androgen Antagonists↗
PubMed2001

Progesterone and ovulation.

The role of progesterone (P) in the mechanism of ovulation is controversial at best. The contraceptive application of P was established in rodents in 1936 and with orally absorbed progestogenes was put to human use. There were hints on the proovulatory actions of P administered before the time of ovulation in rats by 1948. Similarly, in 1954 the observation of high P level in the preovulatory follicle pointed to a role in ovulation. Neither of these two observations was further investigated and the positive feedback effect of P exerted on gonadotropins was described in 1968. Still the positive feedback between P and gonadotropins were not recognized as a physiologic mechanism, much less utilized pharmacologically. The apparent contradiction between these two different actions of P continues upto now. The paper sets out to expose this controversy and tries to resolve it using extensive literary data and the author's experiences with synthetic progestogenes in contraception, in the treatment of infertility and with the antigestagen mifepristone in blocking ovulation. The precise mechanisms lying behind these applications are explored and discussed in detail. The putative role of oestradiol (E2) in the mechanism of eliciting the gonadotropin surge is extensively discussed but refuted as the ovulatory signal. The time sequence between the rise of P and gonadotropins contradicts the common wisdom of LH causing luteinization. The positive feedback effect of P on the E2 sensitized ovulatory axis on the hypothalamic and pituitary level is discussed and its local role in the mechanism of follicular rupture is also taken into account. The final proof seems to be the antiovulatory effect of mifepristone, which blocked both GnRH pulsatility, pituitary sensitivity to GnRH and follicular rupture in several experiments. Thus, the dogma of LH peak causing follicular rupture and subsequent luteinization seems questionable, the putative role of E2 to initiate the ovulatory cascade has to be discarded and P's role as a trigger of the physiological mechanisms leading to ovulation should be firmly recognized.

Animals↗
PubMed1978

Oral contraceptive pills and clinical otosclerosis.

Clinical otosclerosis is a familial disease which is more frequent among women in their reproductive years. The condition usuallly is aggravated by pregnancy. Endocrinologic variables may influence the time of onset and the course of the disease. It is suspected that oral contraceptives (OCs) might stimulate the onset of the disease. Six hundred nulliparous women between the ages of 16 and 30, who used a variety of OCs for 12-36 months, were examined. The hearing of these women was thoroughly investigated. The first audiometric examination of the 600 women revealed three cases (0.5%) of clinical otosclerosis. This incidence is equal to that of the population as a whole, but lower than the incidence found in previously parous women. Audiometric examinations were normal in the remaining 597 women, and repeated examinations revealed no new cases of clinical otosclerosis, despite continuous OC use.

Adolescent↗
PubMed1984

Effect of cimetidine on the hepatic extraction of indocyanine green, the portal pressure and the systemic circulation in patients with cirrhosis of the liver.

The effect of cimetidine on hepatic and systemic haemodynamic parameters was studied in seven patients with portal hypertension due to alcohol-induced cirrhosis of the liver and in one patient with peliosis hepatis following oral contraceptive steroids. The intravenous administration of cimetidine (350 mg as bolus, followed by 2 mg/min over 60 min) reduced the hepatic extraction of continuously infused indocyanine green (ICG) by 27%; this was statistically significant (P less than 0.01). Since the ICG clearance, calculated independently of hepatic perfusion, was lowered by 19%, this effect seems to be mainly due to a reduced capacity of the liver to remove the dye from the blood, rather than due to changes in perfusion. Cimetidine did not influence the elevated portal pressure in the patients with cirrhosis, or the normal pressure in the patient with peliosis hepatis. No significant effect was observed on heart rate, mean arterial pressure, pulmonary artery pressure, pulmonary capillary pressure and cardiac output. These studies indicate that the reduction of the hepatic ICG extraction following cimetidine is more the result of an inhibited capacity of the liver to remove the dye than of changes in the hepatic perfusion or in the systemic circulation.

Adult↗
PubMed1979

A three-year clinical trial with levonorgestrel silastic implants.

Silastic implants containing the progestin, levonorgestrel, were tested as long-term contraceptives in 101 women. After three full years of exposure and 2,998 woman-months of use, no pregnancies had occurred. The continuation rates were 87% at 12 months, 79% at 24 months and 66% at 36 months. The most important side effect was excessive or irregular bleeding during the first year. No treatment was offered for this side effect other than vitamins and iron or change of method, with the exception of 3 cases where ethinyl estradiol was used one time for 2 weeks each. Bleeding disturbances led 8 patients to ask for removal of implants. Other side effects were headache, acne and lower abdominal pain. Blood and urine analysis tested 17 different parameters and all but plasma cortisol remained within normal limits throughout the study. A general tendency toward lowered cortisol values was observed and two subjects had more than one value below the normal limit for the population during the study. Glucose tolerance tests during the second year were abnormal in two women with familial diabetes but they returned to normal values spontaneously at the next test. It is concluded that levonorgestrel implants offer effective protection against pregnancy during the first three years of continuous use. Their acceptability and few side effects justify larger trials, especially if treatment of bleeding irregularities is introduced.

Abdomen↗
PubMed1993

Evaluation of the clinical performance of a levonorgestrel-releasing IUD, up to seven years of use, in Campinas, Brazil.

The clinical performance of a levonorgestrel IUD, releasing 20 mcg/day, used by 293 women at the Family Planning Clinic of the State University of Campinas, was evaluated up to the end of the seventh year of use. No pregnancies occurred in 899 women-years of observation. The cumulative removal rate for amenorrhea or severe hypomenorrhea was 15.7 per 100 women at seven years. The expulsion rate was within ranges observed with copper IUDs in the same clinic. The continuation rate was 49.5% at three years and 23.7 at seven years. The cumulative loss to follow-up rate was 13.7% at seven years. The effectiveness, good continuation rate, and reduction of the amount of blood loss make this device appropriate to be offered to Brazilian women, as an additional contraceptive option.

Adult↗
PubMed1978

Determination of menstrual prostaglandin levels in non-dysmenorrheic and dysmenorrheic subjects.

We have developed a method which can measure the menstrual prostaglandin (PG) activity in a single tampon specimen by bioassays. This method makes it possible to monitor the menstrual PG activity continuously during menstruation. Using this technique, we determined the menstrual PG patterns of two normal non-dysmenorrheic subjects, one subject on oral contraceptives (OC) and one subject with moderate to severe dysmenorrhea. Two to four cycles were studied per subject. We observed three mentrual patterns among the four subjects studied. Compared to the two normal controls, the subject on OC had a significantly lower menstrual fluid total and menstrual PG activity. The mean values +/- S.E. per menstrual period were 33.4 g +/- 1.5 vs 21.5 g +/- 2.0 and 28.6 microgram (PGF2alpha equivalent) +/- 1.5 vs 11.3 microgram +/- 4.2 respectively (control vs OC). The dysmenorrheic subject had a menstrual fluid total of 37.0 g +/- 1.9 similar to the two normal controls. Her menstrual PG activity (49.8 microgram +/- 7.7), however, was nearly two times higher than the normal controls. In one cycle studied, the dysmenorrheic subject was treated with a PG synthetase inhibitor, ibuprofen (Motrin). Remarkable relief was achieved. The alleviation of symptoms was accompanied by a concomitant marked reduction in the menstrual PG activity.

Adult↗
PubMed1997

Multicenter study of the Lactational Amenorrhea Method (LAM): II. Acceptability, utility, and policy implications.

A multicenter study of the Lactational Amenorrhea Method (LAM) was carried out to determine acceptability, satisfaction, and utilization in 10 different populations, and to confirm the efficacy of the method. Efficacy data are presented in a companion paper. A protocol was designed at the Institute for Reproductive Health (IRH), Department of Obstetrics and Gynecology, Georgetown University Medical Center, and reviewed and modified in collaboration with the co-sponsors, the World Health Organization, the South-to-South Cooperation for Reproductive Health, and the principal investigators from each site. Data were gathered prospectively on LAM users at 11 sites. Data were entered and cleaned on-site, and further cleaned and analyzed at IRH, using country-level and pooled data to produce descriptive statistics. The overall satisfaction with LAM was 83.6%, and continuation with another method of family planning was shown to be 67.6% at 9 months postpartum, in most cases exceeding previous use of contraception prior to use of LAM. Knowledge and understanding of the method at discontinuation were high, ranging from 78.4 to 88.6% for the three criteria. LAM can be used with a high level of satisfaction and success by women in a variety of cultures, health care settings, socio-economic strata, and industrial and developing country settings. The results confirm that LAM is acceptable and ready for widespread use, and should be included in the range of services available in maternal and child health, family planning, and other primary health care settings.

Adult↗
PubMed1997

Type I hereditary angio-oedema. Variability of clinical presentation and course within two large kindreds.

OBJECTIVES: Hereditary angio-oedema (C1-inhibitor deficiency) is a disease with protean manifestations which is often misdiagnosed initially. The purpose of this study was to delineate the clinical spectrum and course of this potentially life-threatening disease. SETTING: Ten members of two unrelated affected kindreds were repeatedly hospitalized in our service with attacks of angio-oedema. Among the 271 members of the two kindreds 69 were identified who reported typical attacks. DESIGN AND SUBJECTS: Detailed information on the clinical course and laboratory data (C1-inhibitor concentration and activity, C4 concentration) were obtained from 59 of the 69 affected subjects. RESULTS: C1-inhibitor concentration and activity were low in all affected patients. The disease had become manifest by age 30 years in 98%. Most patients suffered from attacks of subcutaneous swellings and abdominal pain, and half of the patients have had attacks affecting the airways. The frequency of attacks ranged from less than one to over 26 per year. Forty-two per cent had to be hospitalized at least once. Four have died of acute airway obstruction. Thirty-eight attacks in 10 patients hospitalized in our service were all treated successfully with fresh frozen plasma or with C1-inhibitor concentrate. Trauma, stress, insect stings and foodstuff were triggering factors, but the majority of attacks occurred without an identifiable trigger. Oral contraceptives and pregnancy led to worsening of symptoms. Nonetheless, all 36 pregnancies reported were carried to term. Twenty-five patients were on continuous treatment with attenuated androgens or tranexamic acid, but only seven were free of attacks in the year preceding the survey. CONCLUSION: Hereditary angio-oedema is an autosomal dominant disease with great variability of clinical expression and severity, even within a single kindred. It often goes unrecognized over years, and it may lead to death if, in case of impending airway obstruction, specific therapy is not instituted.

Acute Disease↗
PubMed1999

Quality of epilepsy treatment and services: the views of women with epilepsy.

In three focus group discussions, 18 women with epilepsy were asked about their experiences of and satisfaction with care and treatment at both primary and secondary care, and for views on how epilepsy services might be improved. A fourth focus group was held with six epilepsy nurse specialists to seek their opinions on the service needs of women with epilepsy. Criticisms of services identified by both the women and nurses typically concerned four areas of care; organisation of services, technical competence, information provision and interpersonal skills, and health outcomes. Specific criticisms in each area included: lack of continuity of care and shared care; poor provision of information about side-effects of antiepileptic drugs (AEDs) and their effect on the contraceptive pill; and apparently haphazard prescribing of AEDs with consequent serious side-effects. Recommendations for improvements in services and treatment for people with epilepsy are suggested.

Adult↗
PubMed1994

Dietary fat intake and risk of epithelial ovarian cancer.

BACKGROUND: Evidence exists that dietary fat may be a contributory factor in the development of hormone-related cancers such as ovarian cancer. Previous studies have demonstrated significantly higher circulating-estrogen levels among nonvegetarian women than among vegetarian women; the increase correlated directly with consumption of saturated fat. However, the contribution that dietary fat plays in the development of hormone-related cancers remains unresolved. PURPOSE: Our purpose was to evaluate whether saturated fat intake increases the risk of ovarian cancer development. METHODS: Population-based sampling was used to acquire cases and controls over a 3-year period from the study area, which included the highly populated region surrounding the western end of Lake Ontario, Canada. From the Ontario Cancer Registry, all histologically confirmed, primary malignant or borderline malignant epithelial ovarian tumors first diagnosed from November 1989 through October 1992 among study-area residents aged 35-79 years were determined. In total, 631 eligible case subjects were identified, of whom 450 (71.3%) were interviewed concerning reproduction and diet; 564 randomly selected population control subjects were similarly interviewed. From the quantitative diet-history information, average daily intakes of macronutrients and micronutrients were calculated. Unconditional continuous logistic regression methods were used for analysis, with adjustment for age at interview, number of full-term pregnancies, years of oral contraceptive use, and total daily caloric intake. RESULTS: Saturated fat consumption was associated with increasing risk of ovarian cancer (odds ratio [OR] = 1.20 for each 10 g/day of intake; 95% confidence interval [CI] = 1.03-1.40; one-sided P = .0082). No relationship was seen with intake of unsaturated fats. Egg consumption also appeared related to increased risk (OR = 1.42 for each 100 mg of egg cholesterol per day; 95% CI = 1.18-1.72; two-sided P = .0002), though this association may have resulted from disease-related changes in the dietary practices of case subjects prior to diagnosis. Consumption of vegetable fiber (but not fruit or cereal fiber) was associated with decreased risk (OR = 0.63 for each 10 g/day; 95% CI = 0.49-0.80; two-sided P = .0001). All three nutrients (saturated fat, egg cholesterol, and vegetable fiber) remained statistically significant when included in the same regression model. CONCLUSION: Diet may contribute to risk of ovarian cancer development. IMPLICATION: If confirmed in further studies, this association may allow women to appreciably lower their risk of ovarian cancer through dietary modifications: reducing the intake of saturated fats and eating more vegetables.

Adult↗
PubMed2003

Perforation with the GyneFix intrauterine implant: is there a common factor?

This report describes an asymptomatic perforation with the GyneFix intrauterine contraceptive implant. A review of all other reports of this complication has been performed. Analysis of these reports suggests prolonged amenorrhoea secondary to continuous progestogen use as a possible common predisposing factor.

Adult↗
PubMed1996

Transition from high to replacement-level fertility in a Kerala village.

This paper uses a micro-approach to examine the motivation and processes of rapid fertility decline in a Kerala village. Fertility declined in the village substantially during the 1970s and continued to decline to reach replacement level at the time of study. The proximate determinants are postponement of marriage and extensive use of contraceptives. However, the changes in these factors were the result of changing socio-economic conditions. At the time of study the singulate age at marriage was 29 years for males and 23 years for females, higher than elsewhere in India. Delayed age at marriage was a combined effect of favourable attitudes to education and economic changes. Smaller families became advantageous because of decreasing agricultural opportunities, expanded education and mortality decline. Contraceptives were available with the implementation of the family planning program. Higher use of contraceptives can be attributed to favourable conditions resulting from socio-economic changes.

Adolescent↗
PubMed1998

Contraception: a review.

Recent years have seen a dual development in contraception: on the one hand, advances in technology have widened the choice for women; on the other, the right of women to informed and free choice has been reaffirmed. The need to provide contraceptive users with impartial and up-to-date advice was highlighted by the pill scare of 1995. The extreme safety of the pill when used by low risk women was confirmed in several reports. However, interest in long-acting systemic non-oral methods continues to increase as providers seek methods with minimal compliance requirement and therefore higher efficacy which, in the case of the hormone releasing intrauterine system (IUS) and injectable progestogens, approach the efficacy of female sterilisation. Globally the intrauterine device (IUD) had topped the league of reversible contraceptives for many years but had had mixed fortunes in some developed countries, especially the US. A revival of the IUD is on the way, mainly because of the impressive performance of the IUS and the recent introduction of a frameless device, the GyneFix.

Contraception↗
PubMed1980

Precancerous mastopathie: structural and biological considerations.

The clinical and biological correlates of specifically classified non invasive breast lesions were compared with those of invasive breast cancer. Lesions classified as precancerous mastopathy and in situ carcinoma were shown to be related to invasive cancer, structurally, temporally, antigenically and in terms of some, but not all risk factors. Mammary carcinogenesis seems to be a discontinous step wise process in which the development of precursor lesions and the precursor to invasive progression are separable phenomena. It appears that different constellations of risk factors may selectively influence one or the other of these steps. Of particular interest are data which suggest that oral contraceptives (OC) favor the precursor to invasive transition in women whose grandmothers and/or aunts had breast cancer but impede this step in women without a family history of breast cancer. There is need for registries of breast diseases which routinely collect data on the clinical and analytical characteristics of specifically classified non invasive as well as invasive breast lesions, derived from the same population over the same time period. Our ability to specifically reduce morbidity and mortality from breast cancer may be more dependant on a better understanding of the development and progression of precursor lesions than on a continued preoccupation with already invasive breast cancers.

Breast Diseases↗
PubMed2000

Acceptability and performance of the levonorgestrel-releasing intrauterine system (Mirena) in Campinas, Brazil.

The objectives of this study were to evaluate the acceptability of the LNG-IUS Mirena(R), when offered as an additional option in a free choice context, and to evaluate the possibility of using this method in women with increased bleeding wanting an IUD and in copper IUD users requesting removal of the device for bleeding problems. A total of 256 women chose Mirena and were accepted into the study during the enrollment period. This represents 23.3% of all new acceptors of contraceptive methods in the clinic during the same period. Discontinuations were fairly evenly distributed among expulsion, bleeding changes, pain, and personal reasons. Bleeding changes were decreased bleeding, oligomenorrhea or amenorrhea. Comparing the performance in the group of women who chose the LNG-IUS as a first option with those having heavy bleeding, the only difference found was a higher expulsion rate in the group with bleeding problems. No pregnancies occurred and continuation rate was slightly over 75% in the total sample and in both groups. The characteristics of the LNG-IUS (Mirena) allow predicting that this method can effectively contribute to the increase in contraceptive options when introduced to family planning programs in Brazil.

Brazil↗
PubMed1993

Safety and efficacy of a triphasic oral contraceptive containing desogestrel: results of three multicenter trials.

This report combines the data obtained in three multicenter efficacy studies with a new triphasic oral contraceptive combination containing desogestrel (DSG) and ethinyl estradiol (EE). The studies were conducted at 40 investigational sites in the United States (38 centers) and Canada (2 centers) in support of the FDA approval of the product. In total, 1,095 subjects were exposed to the study medication for 11,231 cycles, corresponding to approximately 864 woman-years of use. Of these subjects, 414 completed at least 13 cycles of treatment. Contraceptive efficacy was high; six pregnancies occurred during the in-treatment period (two due to method failure and four due to user failure), corresponding to Pearl Indices of 0.23 and 0.46, respectively. The incidence of irregular bleeding was low, and the acceptability was excellent as evidenced by the low incidence of drug-related drop-outs. No drug-related serious adverse experiences were reported, and the incidence of other drug-related adverse experiences was generally low and decreased with continued use. No effects were seen on blood pressure, body mass index, laboratory parameters, cervical cytology and breast nodularity. These studies demonstrate that triphasic DSG/EE is an effective and acceptable triphasic oral contraceptive preparation with excellent cycle control and no significant physiologic effects.

Adolescent↗