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[Male hormonal contraception].

Human reproduction is a complex phenomenon remaining at the center of interest of many medical and extra-medical disciplines and the search for new contraceptive methods is an important part of research effort. The development of effective forms of male hormonal contraception (MHC) is one of the priorities of the World Health Organization (WHO Task Force on Methods of Regulation of Male Fertility). The principle of MHC consists in the suppression of spermatogenesis while preserving all other functional aspects of the male glands (especially the sexual functions, bone metabolism and lean muscle mass). It is possible to stop spermatogenesis by blocking gonadotrophin (FSH and LH) secretion by testosterone administration (isolated or in combination with other hormones). The currently existing variants of MHC are based on testosterone application (which has in the same time the role of substitutive treatment--the so-called androgen "add-back") either in monotherapy (oral, intramuscular, transdermal and subcutaneous form) or in combination with various progestins (levonorgestrel, norethisterone, desogestrel, eronogestrel, medroxyprogesterone), antiandrogens or GnRH analogues. The most promising, at present, seem to be the methods which use a combination of depot testosterone preparations with long-acting progestins. To what extent will the role of MHC be important in the future--this can only be judged after establishing their effectiveness, full reversibility, safe application, acceptability, and financial accessibility in clinical practice.

Contraceptive Agents, Male↗

[Incidence of ectopic pregnancy in Beijing area].

The incidence of ectopic pregnancy (EP) was studied through the 3 level monitoring network of maternal and child health care (MCH) in the whole Beijing area, including 82 hospitals, 19 MCH centers and 2 institutes for family planning. 1,420 cases of EP were collected in a sample of 2.7 million women of reproductive age (15-49) during one year period from January 1 to December 31 1990. The cases were confirmed by pathological examination or laparoscopy, and method of epidemiological surveillance was used. The results showed that the overall incidence of EP was 0.52 per thousand women of reproductive age in Beijing area, 0.60/1,000 in urban districts and 0.41/1,000 in rural area; 0.67/1,000 in married women, and 0.05/1,000 in the unmarried; for married women the incidence was 0.54/1,000 in women using various contraceptive measures and 1.80/1,000 in women using no contraceptive methods, while women after sterilization had the lowest incidence (0.18/1,000) and women using natural contraceptive measures (rhythm or withdrawal method) had the highest (2.43/1,000). It was 0.65/1,000 in IUD users, 0.21/1,000 in OC users and 0.57/1,000 in couples using condom or spermicides. The ratio of EP to delivery was 1:90 or 11.41/1,000 delivery.

Adult↗

Association of contraceptives and HIV-1 infection in Thai female commercial sex workers.

We conducted a case-control study to evaluate the association between contraceptive methods and HIV infection among Thai female commercial sex workers in Khon Kaen and Lumpang provinces, Thailand; 118 cases of HIV-1 infected sex workers were eligible for inclusion and 258 HIV-1 negative women were recruited as controls during the period of October 1, 1993 to December 31, 1994. Cases and controls were matched by age, education, parity, age at first exposure to commercial sex, number of clients per night, duration of work and sexual practice during menstruation. The ratio of case per control was 1:2. Both cases and controls were interviewed and underwent blood testing by a team of investigators. The study revealed no significant association between oral pill, injection, other contraceptives and HIV-1 infection. However, condom usage showed a significant protective effect. It is suggested that these contraceptives in this high-risk group of women do not increase the risk of HIV infection. In contrast, the use of condoms could reduce the risk of HIV infection.

Adult↗

Women's satisfaction with birth control: a population survey of physical and psychological effects of oral contraceptives, intrauterine devices, condoms, natural family planning, and sterilization among 1466 women.

User satisfaction and the physical and psychological effects of five commonly used contraceptive methods were investigated in a population survey among 1466 West German women. The focus was on effects attributed by current and past users to these methods, rather than objectively assessed effects, to shed further light on personal experiences that are highly relevant to the user but often remain unknown to prescribers and unreported in the medical literature. Within the overall sample, 1303 women were surveyed concerning their current or past use of oral contraceptives (OC), 996 regarding condoms, 342 with respect to intrauterine devices (IUD), 428 in regard to natural family planning (NFP), and 139 in relation to sterilization (respondents completed questions about each method used). It emerged that satisfaction was greatest with sterilization (92% of users), followed by OC (68% of ever users), IUD (59%), NFP (43%), and condoms (30%). Almost one in three NFP users had experienced an unwanted pregnancy during use of this method, as compared with one in 20 OC and condom users. The majority of users reported no mood changes during use of the methods studied. The percentages reporting negative mood changes (various items were scored) were up to 16% among OC users, 23% among condom users, and 30% among NFP users. The latter observations suggested that subjective side effects of a contraceptive agent on mood generally reflected, at least in part, the user's sense of confidence in the method concerned (notably, with regard to efficacy and safety). Oral contraceptives, IUD, and sterilization had a broadly positive impact on sex life, whereas that of condoms was often negative. Whereas OC users often reported less heavy and painful menstruation (in up to 56% of cases), IUD were associated with heavier, prolonged, and more painful menstruation (in up to 65% of cases), as also was sterilization, although to a lesser extent (in up to 32% of cases). Overall, the study findings indicated that OC and sterilization had less negative impact on physical and psychological functioning than the other methods studied, in contrast to what the general public often believes.

Adult↗

Ectopic pregnancy risk when contraception fails. A review.

OBJECTIVE: To alert clinicians to the risk of ectopic pregnancy when certain contraceptive methods fail by summarizing data from trials reviewed by the U.S. Food and Drug Administration (FDA). STUDY DESIGN: The review focuses on 7 contraceptive drug products with an increased risk of ectopic pregnancy when the method fails. Data were extracted from reviews of clinical trials submitted to the FDA to support marketing applications and from the medical literature. Data on 6 other contraceptive drug products and published data for tubal ligations are used for comparison. This review does not include medroxyprogesterone acetate injections because the FDA reviews for this method did not include any pregnancy outcome information. RESULTS: The results are presented in a table and are compared to postmarketing surveillance reports and published literature, when available. The proportion of ectopic pregnancies among all pregnancies ranged from 1:2 to 1:21 for intrauterine devices, tubal ligations, progestin-only implants and progestin-only oral contraceptives. Although the confidence intervals for the proportions were large in trials with few pregnancies, both postmarketing surveillance reports and published literature support proportions calculated from clinical trial data. CONCLUSION: Pregnancies in women using progestin-only oral contraceptives, progestin-only implants, intrauterine devices and tubal ligations are more likely to be ectopic than pregnancies in the general population.

Clinical Trials as Topic↗

Oral contraceptives, depression, and libido.

Depression, headaches, and libido were rated in 272 women before starting a contraceptive method and at intervals during the first year of use-54 were fitted with an intrauterine device (I.U.D.) and 218 used one of three oral contraceptives. Side effects caused 25% of the oral contraceptive group and 13% of the I.U.D. group to stop the method. Depression, headaches, and loss of libido were the most common reasons for stopping oral contraceptives and breakthrough bleeding was the most common reason for stopping the I.U.D.The group of women who stopped or changed their oral contraceptives during the survey were compared with the group who remained on the same oral contraceptive throughout. The former had higher mean depression and neuroticism scores at the first clinic visit and contained more women with a history of premenstrual weepiness, depression during pregnancy, outpatient psychiatric treatment, and treatment with antidepressants. Changes in the depression, headache, and libido ratings throughout the survey are presented.

Adult↗

Commentary: the quest for women's prophylactic methods--hopes vs science.

The companion article by Rosenberg and Gollub in this issue summarizes data from 10 observational studies and concludes that female-controlled contraceptive methods, under typical conditions, are comparable to condoms in preventing sexually transmitted diseases and should be merchandized as such. While we agree that chemical and mechanical contraceptives provide protection against some sexually transmitted diseases, we think the authors have overstated the scientific case for these methods, especially in comparison with the condom. We think the current data remain inconclusive regarding the absolute protection of spermicides against the human immunodeficiency virus and their level of protection--relative to that of the condom--against other sexually transmitted diseases. Three reasons account for our differences: the limitations in the comparative data; the reported adverse effects of spermicides on vaginal conditions, including genital ulcers; and the relative value of condoms, even under typical conditions, in preventing sexually transmitted diseases. For these reasons, we would currently counsel both women and men who practice high-risk sexual behaviors to use condoms as their first line of defense. If this is unacceptable, the female barriers become a fallback position to protect against bacterial sexually transmitted diseases.

Condoms↗

The effects of sex education on adolescent behavior.

By age 18, according to the 1982 National Survey of Family Growth, 68 percent of 15-19-year-old women have received formal instruction about pregnancy and contraceptive methods, 16 percent have had instruction about pregnancy only, and another 16 percent have received neither type of education. The age at which formal contraceptive education is first provided has been declining; among 15-year-olds, for example, 47 percent have had instruction by their 15th birthday, compared with 33 percent of 17-year-olds and 26 percent of 19-year-olds. Forty-six percent of adolescent women have had premarital intercourse. Exposure to formal sex education appears to have no consistent effect on the subsequent probability that a teenager will begin to have intercourse. Sex education does influence contraceptive knowledge and behavior, however. Sexually active teenagers who have had formal instruction report knowing how to use more methods than do adolescents who have had no instruction. The former group is also significantly more likely to have practiced contraception at some time. And among ever-users, those who have received pregnancy and contraceptive education before first coitus are significantly more likely to have used a method at first intercourse. Nearly one-third of premaritally sexually active adolescents have had at least one premarital pregnancy. The NSFG data reveal no significant relationship between exposure to sex education and the risk of premarital pregnancy among sexually active teenagers.

Adolescent↗

[Effects of mifepristone of different doses on emergency contraception, a randomized double-blind study].

OBJECTIVE: To compare the effects of mifepristone of different doses on emergency contraception. METHODS: 3,052 healthy women with regular menstrual cycle who visited the 10 family planning institutes and hospitals in Beijing, Shanghai, Shangdong, Sichuan, Tianjin, Guangdong, and Liaoning for emergency contraception within the period of 120 hours after a single act of unprotected sex were given a single dose of 10 mg or 25 mg mifepristone randomly and double-blindly. They were asked to record the vaginal hemorrhage that would occur and not to have unprotected sex until the next menstrual onset when they were followed up. The trial for a specific subject ended when she menstruated. If the menstruation was irregular or a specific subject failed to menstruate on time a blood or urine human chorionic gonadotropin (hCG) test was made. If the hCG test was negative, an appointment was made to follow up once one week later. If the hCG test was positive ultrasound examination was made to detect pregnancy. If the subject still failed to menstruate and the hCG test was still negative follow-up for this subject could be finished. RESULTS: Twenty-two of the 3,052 subjects were lost to follow up. Among the remaining 3,030 women 1,516 were in the 10 mg group and 1 514 in the 25 mg group. Seventeen pregnancies occurred in each group, with a pregnancy rate of 1.1% for both groups. The relative risk of pregnancy of treatment of 25 mg mifepristone in comparison with treatment of 10 mg mifepristone was 1.0 (95% CI: 0.51-1.95). Both doses prevented about 85% approximately 86% of the anticipated pregnancy if no measure had been adopted. The pregnancy rate nearly doubled in the women who had unprotected sex after treatment of mifepristone. The efficacy of mifepristone decreased along with the delay of mifepristone administration. Side effects were uncommon and mild. Delay of 7 days or more in the onset of next menstruation occurred in 9%-10% of the women. CONCLUSION: Mifepristone of the dose of 10 mg is safe and effective for emergency contraception. Earlier administration is preferable, although the method can be used effectively up to five days after the unprotected sex.

Adult↗

Changing men's involvement in reproductive health and family planning.

The shift in focus on men's reproductive health was influenced by the 1994 Cairo (ICPD) Action Plan to promote gender equality and equity, empower women, and improve family health in society. Changing and improving the way in which men are involved in reproductive health can only have a positive impact on women's, men's, and children's health. Educating and counseling men about contraceptive choices is essential if they are to be supportive of women's reproductive health. Research on new male contraceptive methods must continue if the bias of women shouldering the major responsibility for contraception is to be eliminated.

Attitude to Health↗

A 1-year randomized study to evaluate the effects of a dose reduction in oral contraceptives on lipids and carbohydrate metabolism: 20 microg ethinyl estradiol combined with 100 microg levonorgestrel.

OBJECTIVES: To evaluate the impact on lipid and carbohydrate variables of a combined one-third ethinyl estradiol (EE)/levonorgestrel (LNG) dose reduction in oral contraceptives. METHODS: In an open-label, randomized study, a dose-reduced oral contraceptive containing 20 microg EE and 100 microg LNG (20 EE/100 LNG) was compared with a reference preparation containing 30 microg EE and 150 microg LNG (30 EE/150 LNG). One-year data from 48 volunteers were obtained. RESULTS: We found a decrease of HDL2 cholesterol and increases of low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol and total triglycerides in both treatment groups from baseline to the 13th treatment cycle. Although for four of six variables, the changes in the 20 EE group were lower compared with the 30 EE group, none of the differences between the two treatments were statistically significant. The median values for the fasting levels of insulin, C-peptide and free fatty acids slightly increased or remained unchanged while the fasting glucose levels slightly decreased after 13 treatment cycles. While the glucose area under the curve (AUC) (0-3 h) was similar in both groups during the OGTT, the insulin AUC(0-3 h) was less increased in the 20 EE/100 LNG group compared with the 30 EE/150 LNG group. None of the differences between the treatment groups for any of the carbohydrate metabolism variables were statistically significant at any time point. Both study treatments were safe and well tolerated by the volunteers. CONCLUSION: Similar effects on the lipid and carbohydrate profiles were found for both preparations. The balanced one-third EE dose reduction in this new oral contraceptive caused slightly lower, but insignificant, changes in the lipid and carbohydrate variables compared with the reference treatment.

Adult↗

Contraceptive prevalence among young women in Nigeria.

In almost all societies in the world there is an increase in sexual activity among young persons (10-24 years). There is a need for contraceptive use among them to prevent high risk unintended pregnancies. This study was carried out to determine the contraceptive prevalence among young women in Nigeria. The study population was 832 young women between the ages of 15 and 24 years. Only 11.1% of the respondents had ever used contraceptives although 63.2% of them had had sexual intercourse. Contraceptive usage was significantly higher (p<0.05) among the single sexually active women (38.5%) than among the married women (7.7%). Only 7.3% of respondents are currently using a contraceptive method. The main methods in use were condoms and pills. There is an unmet need for contraceptives among young women in Nigeria. It is necessary to improve these young women's abilities to protect themselves against unwanted pregnancies.

Adolescent↗

Early teenage pregnancies in Hull.

OBJECTIVES: To determine the pattern, obstetric outcome and factors that predispose to pregnancies in young teenagers in Hull. DESIGN: Retrospective study of case records of pregnancies from 1977 to 1988 in girls aged 16 years or less and in a control group of nulliparous women aged 20-24 years. SETTING: Hull health district hospitals. SUBJECTS: 1,660 pregnant teenagers and 3,576 nulliparas aged 20-24 years. MAIN OUTCOME MEASURES: Ages at pregnancy, number of pregnancies per year, gestational age at booking and delivery, antenatal complications, mode of delivery, utilization of contraceptives and some social factors. RESULTS: Of the 1,660 pregnancies in the young adolescents, 59-6% were terminations. The youngest girl was 11. The average annual incidence of early teenage pregnancies was 10.5 per 1,000 girls aged 10-16 compared to 6.4 per 1,000 in England and Wales. Physical characteristics and pattern of antenatal care were similar in the study and control groups. Anaemia was 2.53 times as common in teenagers (95% CI 2.19-2.9; P < 0.0001) while hypertension alone was 1.7 times as frequent (95% CI 1.28-2.4; P = 0.002). Pre-eclampsia and proteinuric disorders were similar in the two groups. Apart from prolonged pregnancy, which was significantly less common in the index group, other gestational ages at delivery and birthweights were the same in both groups. The caesarean section rate in the index group was 0.56 times that in the control group (95% CI 0.4-0.75; P < 0.0001) but forceps deliveries were 2.37 times as common in the index group (95% CI 1.80-3.12; P < 0.0001). The uncorrected perinatal mortality rates were 13.6/1000 and 15.7/1000 in the index and control groups respectively. CONCLUSION: Early teenage pregnancies are common in Hull and, contrary to previous reports, are physically well tolerated by the early adolescents who book early and attend antenatal clinics regularly. Ineffective utilization and ignorance of contraceptive methods are contributory factors. We recommend that emphasis should be placed on providing contraceptive services for teenagers and adopting a more purposeful and holistic approach to sex education.

Abortion, Legal↗

Effects of contraceptive use on bone biochemical markers in young women.

The purpose of this study was to compare biochemical markers of bone resorption and formation in young women using different hormonal contraceptive methods. Women aged 18-39 yr who were using depot medroxyprogesterone acetate (DMPA) contraception were recruited for the study; comparison women were matched by age and clinic location. There were 116 women using DMPA, 39 using oral contraceptives containing estrogen and progestin, and 72 not currently using hormonal contraceptives. Biochemical measurements were serum calcium, PTH and osteocalcin, and urine N-telopeptide. Bone density was measured using dual-energy x-ray absorptiometry. The N-telopeptide levels, adjusted for age and other risk factors, were 42.4 +/- 2.3 nmol/mmol creatinine in the DMPA group, 26.2 +/- 3.3 nmol/mmol in the oral contraceptive group, and 35.4 +/- 2.9 nmol/mmol in the nonusers; significant differences were seen in all pairwise comparisons. Osteocalcin levels showed the same pattern, although the difference between the DMPA users and nonusers was not statistically significant. There were no differences among groups in the PTH levels. The bone density at the spine was 1.086 +/- 0.085 g/cm(2) in the DMPA group, 1.103 +/- 0.095 g/cm(2) in the oral contraceptive group, and 1.093 +/- 0.090 g/cm(2) in nonusers (P = 0.051). The results suggest that in women using DMPA bone resorption exceeded bone formation.

Adult↗

Genitourinary medicine: an opportunity to reduce unwanted pregnancy.

We sought to investigate contraceptive use in women attending a genitourinary medicine (GUM) clinic, and to assess the need for a contraceptive service in this setting. Female attendees at Nottingham GUM clinic were invited to complete an anonymous questionnaire regarding past and present contraceptive use and whether a contraceptive service within GUM would be utilized. Four hundred and eighty-nine questionnaires were analysed. The majority had previously used condoms (89.8%) or the combined oral contraceptive pill (COCP) (74.6%), and 46.6% and 37.4%, respectively were currently using these methods. Contraception was frequently used for the dual aims of avoiding both pregnancy and infection (48.5%). General practitioners (GPs) and family planning clinics were most frequently cited as sources of regular contraceptive advice, 58.1% and 47.2% respectively, and emergency contraception 50.8% and 37.3%, respectively. If a contraceptive service was available within GUM 56.9% of respondents indicated they would use it.

Adolescent↗

Effect of oral and injectable contraceptives on serum calcium, magnesium and phosphorus in women.

BACKGROUND: This study aims at evaluating serum calcium, magnesium and phosphorus levels in women taking oral and injectable contraceptives. METHODS: Serum calcium, magnesium and phosphorus were measured in 50 women taking oral contraceptives (Lofeminal) and 50 women taking injectable contraceptive (Depo-medroxy progesterone acetate and Norigest). These women were used as controls before starting these contraceptives. RESULTS: There was significant decrease in serum levels of calcium, magnesium and phosphorus in women taking oral contraceptives but there was significant increase in these minerals in women taking injectable contraceptives. CONCLUSIONS: It is suggested that these contraceptives should be used with due care and with proper investigations of the women before and during the therapy.

Adult↗

Experiences with Yasmin: the acceptability of a novel oral contraceptive and its effect on well-being.

There are well over 100 million women using oral contraceptives world-wide; however, the number of women taking the pill differs from country to country. In the 1960s when 'the pill' was launched, most women wanted an effective, reversible contraceptive method. In the twenty-first century, they take these properties of oral contraceptives as given and now expect a number of non-contraceptive benefits including lighter and less painful periods, 'clear skin' and an overall improvement in well-being. Many oral contraceptives fall short of this ideal, with women discontinuing their pills because of perceived side-effects including weight gain, mood changes and breast tension. A new oral contraceptive has been developed to help fill this need. It contains 3 mg drospirenone, a progestogen resembling endogenous progesterone, and 30 microg ethinylestradiol (DRSP/EE, Yasmin, Schering AG, Berlin, Germany). It has been shown to be highly effective in preventing pregnancies as well as providing good cycle control. Studies have suggested that rates of dysmenorrhea improved in women taking DRSP/EE as well as in women using an oral contraceptive containing 30 microg ethinylestradiol and desogestrel, but symptoms were more often mild or less often severe in the DRSP/EE group. Drospirenone is quite unique as it is derived from 17alpha-spirolactone and has antimineralocorticoid as well as antiandrogenic properties. The effect of DRSP/EE on skin has been evaluated in women with mild to moderate facial acne. A positive effect on acne and seborrhea was observed, with the median acne lesion count decreasing by 62.5% from baseline to cycle 9, whilst seborrhea decreased by 25.1%. Further areas of research are focusing on premenstrual symptoms. A very recent European study has been completed to assess the effect of DRSP/EE on the general well-being and fluid-related symptoms over six treatment cycles in women desiring contraception. Overall, these results suggest that women who report premenstrual symptoms, including psychological and/or somatic problems, before starting DRSP/EE, have improved scores when their Psychological General Well-Being Index is measured and suffer fewer somatic symptoms. In conclusion, the combination ofdrospirenone with ethinylestradiol provides an effective and well-tolerated oral contraceptive with positive effects on body weight, skin and premenstrual symptoms. These unique features of DRSP/EE may improve well-being and have a positive effect on oral contraceptive continuation.

Adolescent↗