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PubMed2000

Blocking effect of antisera to recombinant zona pellucida proteins (r-ZPA) on in vitro fertilization.

PROBLEM: The zona pellucida is a good target antigen for contraceptive vaccines due to its strong immunogenicity and high tissue specificity. However, this contraceptive effect is inevitably associated with ovarian failure. Therefore, it is necessary to define an epitope of the zona antigen to which the antibody produced inhibits fertilization without any undesirable side effects. METHOD OF STUDY: The DNA fragment coding for the NH2-terminal region of porcine zona pellucida proteins (ZPA) (1-198 amino acids) and human ZPA (1-206 amino acids) was prepared to produce recombinant porcine ZPA (r-ZPA), r-pZPA1-198 and r-hZPA1-206. Using Freund's complete adjuvant. antisera against these proteins were raised in rabbits. RESULTS: The resultant antisera to r-pZPA1-198 and r-hZPA1-206 were cross-reacted with each other on enzyme-linked immunosorbent assay and immunofluorescent staining. The antiserum to r-pZPA1-198 inhibited in vitro fertilization in pigs, but not human sperm binding to the zona pellucida, while the antiserum to r-hZPA1-206 inhibited the human sperm-binding assay. CONCLUSIONS: Antiserum to r-ZPA inhibited fertilization in the animal species possessing a homologous amino-acid sequence as an immunogen. The recombinant protein, r-hZPA1-206 seems to be a feasible candidate for the development of contraceptive vaccines for humans.

Animals↗
PubMed1993

Protein S levels during the normal menstrual cycle and during estrogen therapy for premature ovarian failure.

Protein S levels have been reported to be decreased in pregnancy and with oral contraceptive use. This study monitored the effects of estrogen shifts on protein S levels. Four patients with premature ovarian failure were treated with either oral or transdermal patch estrogen replacement. Blood drawn on days 1, 14, and 28 of therapy was analyzed for estradiol, estrone, free and total protein S, and C4b-binding protein (C4b-BP) levels. Similar studies were performed on six normally cycling control patients and seven postmenopausal women. In healthy females, total levels of protein S fell from 22.1 +/- 0.73 micrograms/mL on day 1 to 19.2 +/- 1.29 micrograms/mL on day 14 (p < 0.023). Free protein S levels declined from 6.45 +/- 0.70 micrograms/mL to 5.59 +/- 0.69 micrograms/mL (p < 0.016). C4b-BP levels did not change during the normal menstrual cycle. Baseline total protein S (44.1 +/- 7.0 micrograms/mL) and C4b-BP (193 +/- 18%) levels were elevated in patients with premature ovarian failure. On oral therapy, there was a strong, negative correlation (r = -0.979, p < 0.021) between C4b-BP and estradiol levels. C4b-BP levels did not change in patients with the patch. Both estrogen therapies produced similar declines (44 to 26 micrograms/mL) in total protein S levels. In all cases, total protein S levels changed as a reciprocal function of estradiol. C4b-BP (128 +/- 6.5%) and total protein S (32.2 +/- 3.0 micrograms/mL) levels were higher in postmenopausal women than in nonmenopausal females. Free protein S levels in postmenopausal women (9.6 +/- 0.6 micrograms/mL) were normal.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1982

[Porphyria cutanea tarda or praematura as a symptom of the hepatotoxicity of hormonal contraception].

It is reported on an evident increase in female patients with porphyria cutanea tarda, seen in dermatological department of Halle/S. since 1975. Our female patients were much younger than patients with p.c.t. usually. 8 women, younger than 40 years in time of manifestation of disease have got contraceptive drugs for many years. Only one women under 40 didn't take contraceptive drugs, but she suffers from a thalassaemia minor. The combination of these diseases we have seen never before. P.c.t. as a follow of orale contraception should be included in calculations of the internal medicine, especially, if females suffer from preceding or coexisting hepatic failures.

Adult↗
PubMed1987

Monitoring the menstrual cycle of humans and lowland gorillas based on urinary profiles of bioactive follicle-stimulating hormone and steroid metabolites.

A sensitive and specific in vitro granulosa cell aromatase bioassay was adapted to measure bioactive FSH (bio-FSH) levels in urine samples. Urinary levels of bio-FSH, immunoreactive LH, estrone conjugates, and pregnanediol-3-glucuronide (PdG) were measured in first morning urine samples during the menstrual cycle in six cycling women and four lowland gorillas. The cycle length of women was relatively constant [28 +/- 1 (+/- SD) days], but varied from 28-38 days for lowland gorillas; the length of the luteal phases was relatively constant for both. All subjects had a midcycle LH peak and a luteal phase elevation in PdG. In addition, urinary estrogen excretion displayed a midcycle elevation that preceded the LH peak and a luteal phase increase similar to that of PdG. The bio-FSH levels in urine of cycling women, although at almost 100-fold higher concentrations, exhibited a pattern that closely resembled that of serum bio-FSH levels reported earlier, with an early follicular phase rise and a midcycle peak. Statistical analysis indicated a highly significant correlation (r = 0.90) between serum and urinary bio-FSH levels during the human menstrual cycle and in women in several hypo- and hypergonadotropic states, including oral contraceptive pill users, hypothalamic amenorrhea, premature ovarian failure, and postmenopause. Although a midcycle bio-FSH surge was also detected in lowland gorillas, two peaks of bio-FSH levels were consistently found during the follicular phase. The late follicular phase increase in bio-FSH levels was presumably involved in follicle selection and preceded the midcycle FSH peak by about 6 days, whereas the timing of the early follicular phase peak was variable, suggesting the involvement of complex regulatory mechanisms. These findings suggest that measurement of urinary bio-FSH levels in humans reflects serum bio-FSH in subjects in several physiological and pathological states. Studies of urinary bio-FSH levels in humans and nonhuman primates are useful in monitoring menstrual cycles, and the gorillas may be a model for understanding human reproductive cycles. The urinary granulosa cell aromatase bioassay should be useful for future assessment of bio-FSH levels in situations where serum measurements are impractical or in animal species for which specific FSH RIAs are not available.

Amenorrhea↗
PubMed1994

Cardiac and neurologic complications in malignant hypertension due to oral contraceptive use.

Malignant hypertension is a rare consequence of contraceptive use. We report here on two young women with malignant hypertension secondary to contraceptive use whose main symptomatology was neurological. Both patients had renal failure, severe left ventricle hypertrophy, and hemorrhagic stroke, all reversible after control of blood pressure and discontinuation of the contraceptive pill.

Acute Kidney Injury↗
PubMed2001

Spinal manipulation for primary and secondary dysmenorrhoea.

BACKGROUND: Dysmenorrhoea refers to the occurrence of painful menstrual cramps of uterine origin and is a common gynaecological condition. The efficacy of medical treatments such as nonsteroidal anti-inflammatories (NSAIDs) or oral contraceptive pills (OCPs) is considerable, however the failure rate can still be as high as 20-25% and there are also a number of associated adverse effects. Many women are thus seeking alternatives to conventional medicine. One popular treatment modality is spinal manipulation therapy. There are several rationales for the use of musculoskeletal manipulation to treat dysmenorrhoea. The parasympathetic and sympathetic pelvic nerve pathways are closely associated with the spinal vertebrae, in particular the 2nd-4th sacral segments and the 10th thoracic to the 2nd lumbar segments. One hypothesis is that mechanical dysfunction in these vertebrae causes decreased spinal mobility. This could affect the sympathetic nerve supply to the blood vessels supplying the pelvic viscera, leading to dysmenorrhoea as a result of vasoconstriction. Manipulation of these vertebrae increases spinal mobility and may improve pelvic blood supply through an influence on the autonomic nerve supply to the blood vessels. Another hypothesis is that dysmenorrhoea is referred pain arising from musculoskeletal structures that share the same pelvic nerve pathways. The character of pain from musculoskeletal dysfunction can be very similar to gynecological pain and can present as cyclic pain as it can also be altered by hormonal influences associated with menstruation. OBJECTIVES: To determine the safety and efficacy of spinal manipulative interventions for the treatment of primary or secondary dysmenorrhoea when compared to each other, placebo, no treatment, or other medical treatment. SEARCH STRATEGY: Electronic searches of the Cochrane Menstrual Disorders and Subfertility Group specialised register of controlled trials, CCTR, MEDLINE, EMBASE, CINAHL, Bio extracts, Psyclit and SPORTDiscus were performed to identify relevant randomised controlled trials (RCTs). The Cochrane Complementary Medicine Field's Register of controlled trials (CISCOM) was also searched. Attempts were also made to identify trials from the National Research Register, the Clinical Trial Register and the citation lists of review articles and included trials. In most cases, the first or corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: Any RCTs including spinal manipulative interventions (e.g. chiropractic, osteopathy or manipulative physiotherapy) vs each other, placebo, no treatment, or other medical treatment were considered. Exclusion criteria were: mild or infrequent dysmenorrhoea or dysmenorrhoea from an IUD. DATA COLLECTION AND ANALYSIS: Five RCTs were identified that fulfilled the inclusion criteria for this review. Four trials involving high velocity, low amplitude manipulation (HVLA), and one involving the Toftness manipulation technique were included. Quality assessment and data extraction were performed independently by two reviewers. Meta analysis was performed using odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes. Data unsuitable for meta-analysis were reported as descriptive data and were also included for discussion. The outcome measures were pain relief or pain intensity (dichotomous, visual analogue scales, descriptive) and adverse effects. MAIN RESULTS: Results from the four trials of high velocity, low amplitude manipulation suggest that the technique was no more effective than sham manipulation for the treatment of dysmenorrhoea, although it was possibly more effective than no treatment. Three of the smaller trials indicated a difference in favour of HVLA, however the one trial with an adequate sample size found no difference between HVLA and sham treatment. There was no difference in adverse effects experienced by participants in the HVLA or sham treatment. The Toftness technique was shown to be more effective than sham treatment by one small trial, but no strong conclusions could be made due to the small size of the trial and other methodological considerations. REVIEWER'S CONCLUSIONS: Overall there is no evidence to suggest that spinal manipulation is effective in the treatment of primary and secondary dysmenorrhoea. There is no greater risk of adverse effects with spinal manipulation than there is with sham manipulation.

Dysmenorrhea↗
PubMed1994

Sex hormones regulate ABR latency.

In an effort to characterize more completely the influence of sex hormones on auditory brainstem response (ABR) latency, we evaluated the ABRs of normal male and female subjects and women with previously diagnosed endocrinologic syndromes. We describe ABR latency results from the following subjects: five normal males, nine normally cycling females on no hormonal therapy, nine females using oral contraceptive pills, five females with premature ovarian failure (POF) undergoing cyclic estrogen-progesterone replacement therapy, and five hyperandrogenized females with polycystic ovarian disease (PCOD) treated with the gonadotropin-releasing hormone agonist, Lupron depot, to suppress ovarian steroid production. All subjects were between 23 and 40 years of age. Serum levels of estradiol, progesterone, testosterone, prolactic, and gonadotropins (lutienizing hormone and follicle stimulating hormone) were measured to document the hormonal status of each of the subjects at the time of the ABR evaluation. Normal cycling females and females with POF underwent ABR testing during different phases of the same cycle. Male subjects and females using birth control pills were studied four times in the same month at 1-week intervals. Females with PCOD were also studied four times; baseline and then at 2-week intervals after the initiation of Lupron depot therapy. Increased ABR wave V peak latencies were found to be associated with elevated levels of estrogen or testosterone. We have previously reported a lengthening of ABR wave V peak latencies coincident with peak estrogen levels during the female cycle.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2003

Assessment of sperm functional competence and sperm-egg interaction.

A precise understanding in the functional competence of mammalian sperm is essential to generate clinical advances for the treatment of infertility and novel contraceptive strategies. The fundamental knowledge on the controlling parameters for spermatozoal activation process will help in the identifying the causes in fertilization failure due to male factor as well as in developing male contraceptive methodologies. The defects in the sperm-egg interaction seem to be one of the controlling mechanisms, however, none of the presently available methods for the evaluation of the fertilizing ability of sperm precisely indicates the reason for the failure or the success of sperm entry into egg. Adequate number of motile spermatozoa with normal morphology and timely occurrence of acrosome reaction are presumably the major prerequisites for the penetration through the egg investments. The present communication briefly reviews some of the main features of mammalian sperm which control the success or the failure of fertilization and existing clinical methods indicating the lack of fundamental knowledge on the sub-cellular and molecular aspects of this unique and species-specific cell-cell interaction.

Acrosome Reaction↗
PubMed2001

Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorders.

DL-Centchroman (67/20; INN: Ormeloxifene) synthesized at the Central Drug Research Institute, Lucknow, is a nonsteroidal once-a-week oral contraceptive. It was introduced in Delhi in July, 1991, marketed in India in 1992 as Saheli and Choice-7 (Hindustan Latex Ltd., Thiruvananthapuram) and Centron (Torrent Pharmaceuticals India Ltd., Ahmedabad), and included in the National Family Welfare Programme in 1995.5 According to post-marketing surveillance, approximately 100,000 women were using this pill and approximately 1100,000 menstrual cycles were covered until 1996. It is a unique need-oriented contraceptive being effective when taken immediately after coitus or routinely as a weekly pill and has the advantage of less frequent administration. Its contraceptive action is quickly reversible. It has long terminal serum halflife of 168 hr in women and exhibits duration of anti-implantation/estrogen antagonistic action of 120 hr, despite a short (24.1 hr) serum halflife, in the rat. In lactating women, it is excreted in milk in quantities considered unlikely to cause any deleterious effect on suckling babies. In phase II and III multicentric trials as a contraceptive, children born of method-and-user failure pregnancies showed normal milestones, without any congenital anomaly. Reports of its promising action in the management of certain hormone-related clinical disorders are available. It has an excellent therapeutic index and is considered safe for chronic administration.

Animals↗
PubMed2001

[The best in 2000 on clinical pharmacology].

The year 2000 provided many new articles in clinical pharmacology and therapeutics in the different fields of cardiology. The authors present some of them in this review. In the field of prevention, the statins were the object of complementary studies showing their value in high cardiovascular risk patients with benefits not only in the reduction of coronary but also cerebrovascular events. These benefits are maintained at long-term. The debate about the value of Vitamin E is still on-going with divergent results (HOPE, SPACE studies...). The absence of secondary coronary prevention by post-menopausal hormone replacement therapy seems to be confirmed. The arrhythmogenic risk of neuroleptic drugs is of increasing concern. New data also suggests the possibility of a venous thromboembolic risk. The NSAIDs are an important factor in the first episode of cardiac failure. The risk of thromboembolism with the 3rd generation of contraceptives has been confirmed. Some data has been published about the safety of drugs used in cardiology: the haemorrhagic risk of LMW heparin in renal failure and of aspirin, even at low doses, drug interactions, aspirin-ACE inhibitors interaction. Future perspectives include the potential value of vasopeptidase inhibitors, of cerebral natriuretic peptide and of therapeutic approaches to induce angiogenesis in ischaemic heart disease (gene therapy, recombining factors).

Aspirin↗
PubMed2002

[Who are the users of emergency contraception?].

INTRODUCTION: A user profile is necessary in order to direct future campaigns for emergency contraception (EC). MATERIAL AND METHODS: Over a three-month period, 423 women with prescriptions for EC were consecutively entered in the study, which was carried out in four inner-city pharmacies in Copenhagen, Denmark. RESULTS: The median age was 24 years (range 13-50 years). Most women (73%) were first-time users of EC. The reason for the current need for EC was most often condom failure (54%) or non-use of any contraceptive method (41%). Only six women (1.4%) reported non-use of contraception because of their knowledge of EC and only four women (0.9%) reported EC as the usual method of contraception. Knowledge about EC more often came from family or friends (51%) and advertising (47%), than from general practitioners (26%) or through sex education in schools (3%). Altogether 282 women (69%) received EC from a doctor in the medical emergency service or a casualty ward. DISCUSSION: Overall, EC is used as recommended. Its availability does not seem to reduce the use of safer contraceptive methods. The mandatory sex education in school should include information on EC.

Adolescent↗
PubMed1984

Comparative evaluation of contraceptive efficacy of norethisterone oenanthate (200 mg) injectable contraceptive given every two or three monthly. Indian Council of Medical Research Task Force on Hormonal Contraception.

A total of 2388 subjects, 1181 for 60 +/- 5-day and 1207 for 90 +/- 5-day treatment regimen with norethisterone oenanthate (NET OEN) 200 mg injection, were observed for 24 months, constituting 28,513 woman-months. This clinical trial represents the largest clinical trial undertaken on NET OEN. The observations indicated that NET OEN given at 60 +/- 5-day intervals provides adequate contraceptive protection. However, as compared to the published studies elsewhere, higher method failures were seen during the first six months of NET OEN usage, when all women were receiving the drug at 60 +/- 5-day intervals. The reasons for this discrepant observation in the present study cannot be explained. The higher method failures reported with 90 +/- 5-day regimen were mainly during the third month following the injection, suggesting reduced contraceptive efficacy of the drug during this period. Thin build women (body weight less than or equal to 40 kg) were at higher risk of involuntary pregnancy. Disrupted menstrual pattern was the major reason for discontinuation ranging between 42-43 per 100 users at the end of 24 months. Amongst these, amenorrhoea was the commonest reason for discontinuation. No change in blood pressure was observed during contraceptive usage. The majority of NET OEN users did not show any change in body weight. The overall continuation rates with NET OEN were lower than those observed in similar conditions with Cu-T 200 mm2 IUCD.

Adult↗
PubMed1989

[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↗
PubMed2003

Premature ovarian failure: frequency and risk factors among women attending a network of menopause clinics in Italy.

OBJECTIVE: To determine the frequency and causes of preterm ovarian failure (menopause before 40 years of age) and early menopause (menopause between 40 and 45 years). DESIGN: Cross sectional study. SETTING: Menopause clinics in Italy. POPULATION: Women attending menopause clinics in Italy. METHODS: Between 1997 and 1999 we conducted a large cross sectional study on the characteristics of women around menopause attending a network of first-level outpatient menopause clinics in Italy for general counselling about menopause or treatment of menopausal symptoms. Eligible for the study were all women aged 45-75 years consecutively observed for the first time at the participating centres on randomly selected days during the study period. MAIN OUTCOME MEASURE: Factors associated with preterm ovarian failure. RESULTS: Out of 15,253 women aged 55 years or more with spontaneous menopause who entered the study, 269 (1.8%) reported preterm ovarian failure, and 1085 (7.1%) reported spontaneous menopause at age 40-45 years. The risk of preterm ovarian failure and of early menopause was higher in women reporting lifelong irregular menstrual cycles: in comparison with women reporting menopause at age > or =45 years, the OR (irregular vs regular menstrual cycles) of preterm ovarian failure was 1.3 (95% CI 1.0-1.7) and of early menopause of 1.2 (95% CI 1.0-1.5). Parous women reported less frequently preterm ovarian failure (chi(2) trend P < 0.05) and early menopause (OR 0.8, 95% CI 0.7-1.0). No significant association emerged between risk of preterm ovarian failure or menopause at age 40 to <45 and education, age at menarche, oral contraceptive use and smoking habits. CONCLUSION: Nulliparity and lifelong irregular menstrual cycles are associated with an increased risk of preterm ovarian failure.

Age Factors↗
PubMed2003

Further investigation on meloxicam contraceptivity in female rabbits: luteinizing unruptured follicles, a microscopic evidence.

Meloxicam, a selective cyclooxygenase-2 inhibitor, was administered orally or intravaginally, to sperm-positive female rabbits to assess its effect on ovulation. A single oral dose (20 mg/kg), administered 5 h postcoitus resulted in 100% contraceptive rate. On the other hand, for females receiving meloxicam suppositories (14.9 mg/kg), 5 h postcoitus, the contraceptive rate was 62.5% compared to placebo. The decrease in the contraceptive effect of meloxicam suppository may be due to the rejection of the dose by some females. Corpora lutea, maternal plasma progesterone, ovary fresh weight and maternal body weight gain were not affected by meloxicam treatment compared to placebo. Histopathologically, the surface of the ovary of meloxicam-treated females appears irregular and dilated due to the presence of different-sized cysts. Some of the cystic follicles were retained ova. Further, immunohistochemical stains for estrogen and progesterone receptors showed positive staining in granulosa cells and the wall of the unruptured follicle. It is concluded that contraceptive effect of meloxicam in female rabbits resulted in a failure of follicular rupturing.

Administration, Intravaginal↗
PubMed1999

Estimating the efficacy of medical abortion.

Comparisons of the efficacy of different regimens of medical abortion are difficult because of the widely varying protocols (even for testing identical regimens), divergent definitions of success and failure, and lack of a standard method of analysis. In this article we review the current efficacy literature on medical abortion, highlighting some of the most important differences in the way that efficacy has been analyzed. We then propose a standard conceptual approach and the accompanying statistical methods for analyzing clinical trials of medical abortion and to explain how clinical investigators can implement this approach. Our review reveals that research on the efficacy of medical abortion has closely followed the conceptual model used for analysis of surgical abortion. The problem, however, is that, whereas surgical abortion is a discrete event occurring in the space of a few minutes or less, medical abortion is a process typically lasting from several days to several weeks. In this process, two events may occur that are not possible with surgical abortion. First, the woman can opt out of the process before a fair determination of efficacy can be made. Second, the process of medical abortion allows time for surgical interventions that may be convenient for the clinician but not strictly necessary from a medical perspective. Another difference from surgical abortions is that, for medical abortions, different medical abortion protocols specify different waiting periods, giving the drugs less time to work in some studies than in others before a determination of efficacy is made. We argue that, when analyzing efficacy of medical abortion, researchers should abandon their close reliance on the analogy to surgical abortion. In fact, medical abortion is more appropriately analyzed by life table procedures developed for the study of another fertility regulation technology; contraception. As with medical abortion, a woman initiating use of a contraceptive method can change her mind after some period of exposure and opt out. Also, as with medical abortion, a contraceptive can fail, usually with the risk of failure depending heavily on whether or not the woman follows the protocol for that method precisely. Finally, as with medical abortion, medical conditions may arise that necessitate discontinuing use of the contraceptive method. In both cases, these medical conditions are sometimes open to interpretation or subject to the skill, judgment, or experience of the clinician involved. The appropriate information to collect for a multiple decrement life table analysis of medical abortion includes data on compliance with the protocol, timing of the event of interest (abortion) when it is observable, and, because we argue that these should be regarded as events of interest, a typology of any surgical interventions that are conducted during the woman's participation in the study.

Abortion, Incomplete↗