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Treatment of bleeding problems associated with progestin-only contraceptives: survey results.

Simple, well-documented, effective and inexpensive management approaches are needed for the short-term control of bleeding in progestin-only contraceptive (POC) users. Long-term continuation may improve if acceptable approaches are found to ameliorate these short-term bleeding problems. Family planning providers and researchers were surveyed on the treatment regimens they used for POC-associated bleeding disturbances. Results from this limited survey indicate that no clear indication exists regarding the duration and, severity of bleeding and spotting requiring pharmacologic intervention. Counseling was seen as a critical factor when considering treatment for these problems. This report presents the results of this survey on the different treatment regimens being used by providers throughout the world to treat POC-associated bleeding disturbances.

Anti-Inflammatory Agents, Non-Steroidal↗

[Residual function in the ovary during low-dose oral contraceptive treatment].

Development in oral contraceptives during the past 20 years has involved continued reduction in the total quantity of hormone and alterations in the oestrogen/gestagen ratio and in the steroid structure for the gestagens employed. These changes have been undertaken primarily to counteract metabolic side effects and influence on the haemostatic system. Inhibition of the mechanism of ovulation is, however, also dependent on the steroid dosage and in cases where low-dosage oral contraception is employed, ultrasound investigations have demonstrated a risk of continued ripening of follicles during treatment. Correspondingly, hormone measurements during the pill-free week have demonstrated increase in the follicle-stimulating hormone, luteinizing hormone and the oestrogen concentration. The permissible margin of error in employing oral contraception has therefore diminished and is more dependent on the dosage and potency, particularly of gestagens. As the critical phase for failure of treatment is the first week of intake of oral contraceptives, it is important that treatment is commenced at the correct time not only at the commencement of treatment but also after the pill-free periods. If a pill is forgotten during the preovulatory oestrogen level and two pills are then taken, this may be interpreted by the organism as a positive oestrogen feed-back and, theoretically, this may result in increased gonadotropin production and thus further increase the risk of ovulation. In cases with the risk of malabsorption on account of gastro-intestinal disease and in cases with interaction with other medicaments, employment of alternative forms of contraception is recommended.(ABSTRACT TRUNCATED AT 250 WORDS)

Contraceptives, Oral, Combined↗

The Nova-T 200 intrauterine contraceptive device: a 12 year study.

AIM: To evaluate the long term clinical performance of the Schering Nova-T 200 intrauterine contraceptive device. METHOD: From 1982 to 1990, 446 women were fitted with their first Nova-T IUD's and followed up until December 1994. By this cut off data, 21 (4.7%) were lost to follow up. These were excluded to simplify analysis. RESULTS: Of the remaining 425 women, there were 383 multipara and 42 nullipara. Thirty one percent were fitted with a new Nova-T after 4 years of use. The method was uncomplicated in 70% of multiparous women, but in nulliparous users, the removal rate for unacceptable bleeding and/or pain was found to be 40% compared to 19% for the multipara. An expulsion rate of 4.9% was recorded. The overall cumulative accidental pregnancy rate was 3.5% with a Pearl Index of 1.2 per hundred woman years, a lower rate in older users being the only age related event in the study. Possible pelvic inflammatory disease was recorded in 2.8% with a Pearl index of 0.96. There was no evidence of subfertility after removal in any of the 53 women where a pregnancy was desired. CONCLUSION: The Nova-T 200 IUCD is safe and cost effective and should continue to be offered as a contraceptive option for properly selected women. Although poorly tolerated by nullipara, it proved to be very satisfactory for multiparous women, particularly nursing mothers and those over 40 years of age.

Adult↗

Outcomes of extended oral contraceptive regimens with a shortened hormone-free interval to manage breakthrough bleeding.

OBJECTIVE: To evaluate in a clinical practice setting the acceptance, continuation and variability of extending the active interval of oral contraceptives (OCs) with introduction of a shortened hormone-free interval (HFI) to manage breakthrough bleeding. METHODS: A retrospective review was undertaken of patients seen by one obstetrician/gynecologist and counseled on extending the active interval of OCs with a shortened HFI of 3-4 days to manage bleeding. Electronic medical records were searched for the phrase "extending the number of active pills" for patients counseled between January 1, 2000, and January 31, 2003, with follow-up through January 31, 2004. A structured query of each patient's initial and follow-up records was performed. RESULTS: The 220 patients counseled on the extended regimen were 14-52 years of age (mean 36.4, SD 9.3 years). At initial counseling before extending, the majority of patients cited more than one reason for using OCs in the standard fashion with 59% using OCs for noncontraceptive reasons. Reasons for extending the active interval of OCs included premenstrual symptoms (45%), dysmenorrhea/pelvic pain (40%), heavy withdrawal bleeding (36%), menstrual associated headaches (35%), convenience (13%), acne associated with menses (10%) and other (15%). Of the 181 patients with follow-up data, 174 (96%) attempted an extended regimen with 121 (67%) continuing to do so at last follow-up. Follow-up intervals ranged from 0.3 to 3.8 years (mean 1.6 years). Using Kaplan-Meier product limit survival analysis, 60% of patients continued using extended patterns of OCs for more than 2 years. For 121 currently extending, the HFI varied from 0 to 7 days with 88% utilizing a 0 to 4 day HFI. CONCLUSIONS: Sixty percent of patients offered extending the active interval and shortening the HFI of OCs initiate and continue this pattern for more than 2 years without serious sequelae or pregnancy while individually directing both the number of days of continuous pills and the length of the HFI.

Adolescent↗

Effects of progestins on cardiovascular diseases: the haemostatic system.

The effect of progestin-only therapy on the haemostatic system has mainly been studied in premenopausal women. Although these studies are difficult to compare, most authors agree that there is no consistent pattern of effects on haemostasis. Oestrogen-progestin combinations have been extensively studied in pre- (combined oral contraceptives) and postmenopausal women (sequential and continuous combined hormone replacement therapy), but mostly with emphasis on the effects of oestrogens. Comparative studies into the differential effects of progestins in combined preparations are scarce. Based on these studies, there is evidence for modifying effects of progestins on oestrogen-induced changes, particularly on fibrinogen, factor VII and the fibrinolytic system. The modifying effects appear to vary among certain progestins, the variation being most likely due to differential effects on lipid metabolism. The clinical interpretation of steroid-induced effects on the haemostatic system is difficult. Retrospective analyses linking certain patterns of haemostatic regulation to the risk of venous or arterial vascular diseases are subject to bias, and no interventional studies are yet available. In the absence of such prospective studies and well-designed comparative studies, the available data do not support the notion of a superiority of certain progestins with regard to cardiovascular risks of combined preparations.

Cardiovascular Diseases↗

Selection of oral contraceptives or hormone replacement therapy: patient communication and counseling issues.

Oral contraceptives and combination hormone replacement therapy are underused by most women. Among users, lack of compliance/adherence to oral contraceptive or hormone replacement therapy regimens can lead to discontinuation and deprive women of the full range of benefits achieved through hormone continuity. To prevent unintended pregnancy and to improve the health outcomes of women of all ages and the overall quality of life, adherence and continuation rates need to be improved for oral contraceptive and hormone replacement therapy use. Effective communication and counseling during the oral contraceptive and hormone replacement therapy regimen selection process and subsequent follow-up interactions are essential. Patients need to be informed in a clear and concise manner that, for most women, the benefits of oral contraceptives and hormone replacement therapy outweigh any associated health risks. Data should be presented without epidemiologic jargon and in terms that are easily understood. It is recommended that realistic expectations concerning the possible side effects, especially during the initial use of hormones, are established before use; furthermore, the selection of a formulation should take into account the unique needs of each patient.

Contraceptives, Oral↗

Contraceptive use and discontinuation: findings from the contraceptive history, initiation, and choice study.

OBJECTIVE: The purpose of this study is to provide insight on the continuing high rate of unintended pregnancy among adult women. STUDY DESIGN: Contracepting women were recruited while they waited for primary care appointments. A total of 369 completed the baseline questionnaire, and 145 oral contraceptive (OC) users were enrolled in a 5-week, diary-based study of adherence and sexual activity. RESULTS: Most women who reported having discontinued OCs did so because of medical side effects, and most had switched to less effective methods. Among OC users, 26.4% had sexual intercourse on days they missed pills just before or after their placebo week. Nonadherence did not differ by socioeconomic factors or obesity. CONCLUSION: Clinicians may need to encourage their patients to discuss their reasons for wanting to discontinue the use of an effective contraceptive method and assist them with their concerns or to switch to other effective methods to protect themselves from unintended pregnancy.

Adult↗

Interception by post-coital IUD insertion.

After the development of postcoital hormonal interception, the postcoital use of IUDs to prevent pregnancy was proposed by Tatum. The major advantage of this treatment is that it avoids the use of the usual massive dose of estrogens (a very effective postcoital method) which is associated with nausea and vomiting. This is the 1st method to be effective up to 5 days after exposure, 3 days more than the estrogen treatment. It may also provide long-term contraception in women who wish to continue using the IUD. A major disadvantage of postcoital IUD use is that IUD insertion can produce serious complications if a patient has a vaginal or venereal infection or an asymptomatic cervicitis or even pelvic inflammatory disease (PID). After proper physical examination, suitable patients are selected from those requesting postcoital treatment. Cases involving rape are mostly excluded from these services; but, if they present early, proper work up and treatment can be performed within the time span of 5 days available for this method and it will still be possible to fit a postcoital IUD. The potential risk of future infertility should be considered as PID rates in nulliparous IUD users are up to 7 times higher than in nonusers. Young nulliparous, sexually active women--especially of the lower socioeconomic strata--are identified as high-risk patients. Over 70% of women requesting interception are nulliparous. Clients asking for postcoital insertion should be informed of its potential risk, as women under 25 years of age are more prone to infection. The risk of septic abortion exists if an IUD is inserted into a gravid uterus due to pregnancy resulting from unreported previous sexual intercourse. Septic abortion is a life-threatening condition. Out of several series, no pregnancies are reported in the month of treatment. The IUD preferred is the Multiload copper IUD or the copper T; the highest expulsion rate proved the Copper-7 Gravigard (Cu-7) inefficient. In suitable circumstances, the IUD can be the 1st choice in postcoital interception.

Age Factors↗

[Contraception at 40].

During forty, fertility decreases but the risk of spontaneous pregnancy is not negligible, so contraception for forty years old women remains necessary. Several contraceptive methods are available: local contraception, intra-uterine devices, hormonal contraception. Progestogen-only pills, microdosed and continuously administered are to be avoided at this time of life because they can result in hyperestrogenic adverse events. Progestin implants are interesting if the woman presents contraindication with estrogens or if she is non compliant with oral contraceptives. Oral contraceptive use is associated with numerous benefits during forty: it controls properly cycles and menstruations, it decreases bone loss and it decreases gynaecological disorders and risk of endometrial and ovarian cancer... But cardiovascular risk (venous and arterial thrombo-embolism) remains increased, whatever oral contraceptive is used, second or third generation, and in spite of lower dose of ethinylestradiol, even if a trend towards the decrease of this risk is observed. Contraindication for one kind of oral contraceptive means contraindication for all oral contraceptives and necessarily bare respect of this. These contraindications led to contraceptive use of progestin with antigonadotropic activity; however if pregnane derivatives are devoid of any deleterious metabolic effects, they have no indication for contraception in their marketing authorization.

Adult↗

Gossypol blood levels and inhibition of spermatogenesis in men taking gossypol as a contraceptive. A multicenter, international, dose-finding study.

The safety and efficacy of gossypol continues to be controversial. The aim of this study was to evaluate gossypol as a contraceptive pill for men at doses lower than those previously prescribed and in men from various ethnic origin. A total of 151 men from Brazil, Nigeria, Kenya, and China were divided into two groups. Both groups received 15 mg gossypol/day for 12 or 16 weeks to reach spermatogenesis suppression. Subjects were then randomized to either 7.5 or 10 mg/day for 40 weeks. In addition, 51 men were enrolled as a control group. In all, 81 subjects attained spermatogenesis suppression. Only one man discontinued treatment because of tiredness. Potassium levels fluctuated within the normal range. FSH increased consistently. Testicular volume decreased, but after discontinuation, values returned to levels not statistically different from admission. Of 19 subjects on the 7.5 mg/day dose group, 12 recovered sperm counts >20 million/mL within 12 months of discontinuing gossypol. In the 10 mg/day group, sperm counts recovered in only 10 of 24 subjects. Eight of the 43 patients remained azoospermic 1 year after stopping gossypol. All men diagnosed with varicocele failed to reverse spermatogenesis suppression. Gossypol blood levels indicated that sperm suppression occurs independently of concentration, whereas spermatogenesis recovery appears to be concentration-dependent. Gossypol may become a medical alternative to surgical vasectomy when the delay in onset of infertility is acceptable. When taken for 1 year, gossypol causes no reduction in sexual desire or frequency of intercourse. The possibility of reversal, occurring in 51% of the men on this regimen within 1 year after stopping gossypol, is an advantage of this compound as compared with surgical sterilization in many parts of the world.

Adult↗

Use of levonorgestrel implants versus oral contraceptives in adolescence: a case-control study.

OBJECTIVE: We compared continuation rates, effectiveness, satisfaction with method, side effects, and condom practices among adolescents using levonorgestrel implants (Norplant, Wyeth-Ayerst Laboratories, Philadelphia) as compared with oral contraceptives. STUDY DESIGN: We conducted a case-control study comparing 94 adolescents < or = 18 years old who received Norplant between March 1, 1992, and Nov. 1, 1993 (cases), with 94 age-matched controls who selected oral contraceptives during this same time period. By use of a structured questionnaire, information was obtained on pregnancy status, duration of use, patient satisfaction, side effects, and condom practices 6 months after initiation. Objective measures included weight on Norplant and oral contraceptive users and hematocrit on implant patients. RESULTS: Forty (43%) oral contraceptive patients compared with no Norplant patients discontinued their selected method before the 6-month interview (p = 0.00). Six patients prescribed oral contraceptives became pregnant. Ninety-three percent of Norplant users expressed overall satisfaction despite experiencing menstrual irregularity and cramping, amenorrhea, nervousness, abnormal hair growth or loss, rashes, and an increase in appetite more often than oral contraceptive users. Although Norplant patients also reported an increase in the duration of menstrual flow and number of days of spotting more often than oral contraceptive users, evaluation of hematocrits in these patients demonstrated a significant increase over the 6-month period (p = 0.00). Assessment of condom practices since initiation demonstrated that Norplant patients used condoms less often than oral contraceptive users (p = 0.00). CONCLUSION: Use of levonorgestrel implants may cause more side effects than oral contraceptives in the early months after initiation but provide superior protection against unintended pregnancy. We concluded that Norplant is a reasonable alternative for adolescents, especially when compliance is an issue.

Adolescent↗

Fertility regulation in nursing women: IV. Long-term influence of a low-dose combined oral contraceptive initiated at day 30 postpartum upon lactation and infant growth.

The study was designed to test the long-term influence of a low-dose combined oral contraceptive upon lactation and infant growth when treatment was initiated at day 30 postpartum. The contraceptive tested contained ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg. Two control groups were formed by women who received an injectable placebo or a Copper T at day 30 postpartum. Women in the injectable placebo group received non-hormonal contraceptives at day 90 postpartum. An exacting list of requirements for admission and continuation in the study was applied to all groups. The oral contraceptive group had a significantly lower percentage of cases in full nursing from the 4th through the 10th postpartum month when compared to both control groups. The average absolute weight of infants in the oral contraceptive group was significantly lower at several ages when compared to the placebo group but not when compared to the Copper T group. No adverse side effects upon infant's health were detected. It was concluded that the oral contraceptive tested showed a moderate inhibitory influence upon lactation when treatment was initiated at the beginning of the second postpartum month.

Adult↗

Training: an integral adjunct to the introduction of newer methods of fertility regulation.

The provision of new technologies of fertility control that are known to be safer, simpler, and more effective may at first result in higher complication rates, particularly if training in the new techniques is inadequate. This was illustrated by analysis of data on several fertility control methods collected by the International Fertility Research Program. Various studies showed significantly higher complication rates earlier in the series than later, including one study in which complication rates fell dramatically after clinical training was provided. Another study showed the highest complication rate among the physicians performing the fewer number of cases. Finally, one analysis documented greater variability in several clinical criteria among the participating physicians than between the two pieces of equipment being compared. These data document that it is essential to train physicians and other staff members in the proper use of new equipment and techniques if the potential improvements offered by new technologies in fertility regulation are to be realized.

Allied Health Personnel↗

The effect of ethinyl estradiol 20 mcg and levonorgestrel 250 mcg on the pituitary-ovarian function during normal tablet-taking and when tablets are missed.

A new combined pill containing 20 micrograms of ethinyl estradiol and 250 micrograms of levonorgestrel has been developed. The safety margin of this type of low-dose preparation needed to be assessed and this was done by evaluating daily levels of LH, FSH, estradiol, progesterone, 1-NG and EE2 as well as cervical mucus characteristics in six patients when one and then two consecutive pills were deliberately omitted mid-way through the cycle. Results demonstrated that there was no evidence of breakthrough ovulation, although there was some continued ovarian steroidogenesis, a feature consistent with previous studies using combined preparations. Existing instructions to patients regarding missed pills should continue in order to ensure maximal contraceptive safety.

Adolescent↗

Tamoxifen and benign breast problems.

The agent tamoxifen plays an important part in the treatment of breast cancer. Although it acts as an antioestrogen by binding to oestrogen receptors, it also has oestrogen agonistic effects on the liver. Recent toxicity studies in rats have revealed that after high dosages both cataracts and hepatocellular carcinomas develop. For these reasons it has been suggested that use of tamoxifen be discontinued for the treatment of benign conditions such as severe cyclical mastalgia and also for trials on the prevention of breast cancer. It is argued that the development of hepatocellular carcinomas in rats is the result of the known oestrogen agonist activity of tamoxifen, with similar results being found in a few women receiving oral contraceptives, the use of which still continues. Studies of the use of the agent for benign conditions should evolve in the context of controlled clinical trials in order that important new indications for tamoxifen are not overlooked.

Aged↗

Reproductive health services for adolescents. Critical legal issues.

The contemporary legal and policy environment has increased the challenges associated with providing health care services to the adolescent population. The issue of reproductive health care services is particularly intense because of the controversial nature of services for contraception and abortion. As the debates continue, one must remember the background against which they are occurring. The current legal framework, developed over nearly 40 years, enables adolescents who are minors to give their own consent for care in numerous circumstances and provides them with a significant level of confidentiality protection, particularly for reproductive health services. Laws have been enacted to expand adolescents' financial access to health care, through targeted publicly funded service programs and expanded health insurance coverage. This background provides the foundation for addressing the current challenges and for protecting and expanding adolescents' access to care.

Abortion, Induced↗