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Supportive European data on a new oral contraceptive containing norgestimate.

Several European studies have been conducted to confirm the efficacy, tolerability, and safety of a new oral contraceptive (OC) combining 250 micrograms norgestimate with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). In a 12-month multicenter German study of 147 women, treatment with this formulation resulted in no pregnancies, a low incidence of side effects, and excellent cycle control. The drug had no effect on estrogen-mediated fibrin formation nor on the activity of coagulation inhibiting or promoting factors. Similarly, the documented low androgenicity of the highly selective progestational agent norgestimate results in a more positive metabolic profile. Glucose, insulin, and hemoglobin A1c concentrations measured before and after glucose loading were not adversely affected by treatment with the norgestimate-containing OC, and all changes were reversible on its discontinuation. In addition, lipid metabolism was positively influenced by the drug. Low-density lipoprotein cholesterol, a known risk factor for cardiovascular disease, was reduced while the cardioprotective lipid fraction, high-density lipoprotein cholesterol, was increased. Clinical trials to determine the OC's effects on coagulation, endocrine function, and carbohydrate and lipid metabolism are reviewed. Also discussed are several studies demonstrating the formulation's unique endometrial effects, which may possibly be related to its low androgenic activity and consequent low incidence of breakthrough bleeding and amenorrhea.

Adolescent↗

Measuring contraceptive effectiveness: a conceptual framework.

We present a conceptual model that outlines the four measures of how well a contraceptive method works: 1) efficacy, 2) effectiveness, 3) perfect-use pregnancy rate, and 4) typical-use pregnancy rate. Moreover, we illustrate how four variables influence these measures: 1) capacity to conceive, 2) frequency and timing of intercourse, 3) degree of compliance, and 4) inherent protection of the method. Because of inter-individual as well as intra-individual variability of the first three variables, generalizing results from a contraceptive clinical trial to other populations is problematic. There is a hierarchy of generalizability of the four outcome measures, with the typical-use pregnancy rate the least generalizable but the easiest to measure, and efficacy the most generalizable but the most difficult to measure. These four variables should be considered in the design and analysis of future contraceptive clinical trials. Finally, this article illustrates why the terms "pregnancy rate" and "failure rate" are not synonymous and why we recommend that the latter term not be used.

Clinical Trials as Topic↗

Cervical changes associated with progestagen-only contraceptives: a team approach.

OBJECTIVES: To report clinical, cytologic and colposcopic findings among women using progestagen-only contraceptives for more than 3 years as compared to nonhormonal contraceptives; and to assess the role of nursing in increasing the women's knowledge about Pap test and risk factors for cervical cancer in a developing country set-up. DESIGN: A prospective cross-sectional comparative study. SETTING: Family-planning clinic of a tertiary care university hospital. SUBJECTS: A total of 325 current users of contraceptive methods for more than 3 years. INTERVENTIONS: Patients were divided into two groups. Group A included 200 patients using progestagen-only contraceptives. While group B comprised 125 patients wearing intrauterine devices. In both groups, the patient was asked about the risk factors and her knowledge about cancer cervix. Clinical and cytologic evaluations of the cervix were done. For each patient, two cervical smears were taken using Ayre's spatula and the endocervical brush. MAIN OUTCOME MEASURES: Clinical, cytologic and histopathologic cervical abnormalities after prolonged use, and the effect of health education or counseling on the patient's knowledge about preinvasive or invasive cervical cancer. RESULTS: Initial naked eye assessment of the cervix revealed statistically significant difference between both groups (p < 0.000). However, cytologic examinations revealed positive cases of low- and high-grade squamous intraepithelial lesions (SIL) in 38 (19%) and 22 (17.6%) in the study and control groups, respectively, without any statistically significant difference. There were no statistically significant differences in both groups regarding the frequency of positive cases whether using Ayre's spatula or the endocervical brush. Women's knowledge was compared in the first and last interviews by the nursing staff involved in health education or counseling. It increased in the counseling group; however, the difference was statistically insignificant. CONCLUSIONS: Prolonged use of progestagen-only contraceptives is not associated with increased risk of abnormal cytologic findings. There was a marked lack of women's knowledge as regards Pap test and cervical cancer with some statistically insignificant improvement after interview and counseling. Extended training of the nursing staff on the procedure of Pap smear would help establish screening programs in the developing countries.

Case-Control Studies↗

Adolescent mothers' utilization of contraceptive services in South Africa.

BACKGROUND: In South Africa, contraceptives, as well as emergency contraceptives, are available free of charge. Since 1996, changed legislation has enabled women of all ages to choose whether they wish their pregnancies to be terminated during the first 12 weeks of pregnancy. Therefore, adolescent mothers, 19 years or younger at the time of their babies' birth, were investigated regarding why they failed to use contraceptive, emergency contraceptive or termination of pregnancy services. AIM: To explore the knowledge of young mothers regarding contraception. METHOD: An exploratory descriptive survey, utilizing questionnaires and convenience sampling. FINDINGS: The majority of the participating 250 adolescent mothers lacked knowledge about contraceptives, emergency contraceptives and termination of pregnancy services. Merely legalizing the termination of pregnancies, and providing free contraceptive and emergency contraceptive services, did not affect the utilization of these services by the 250 adolescent mothers investigated. CONCLUSION: Young mothers require more knowledge to enable them to make better informed decisions, and the services need to become more readily accessible and user friendly to adolescents. Reproductive health services provided specifically to adolescents could enhance the utilization of such services.

Adolescent↗

Male hormonal contraception.

Male hormonal contraceptive methods are based on the principle of pituitary gonadotrophin suppression and intratesticular testosterone depletion, leading to suppression of spermatogenesis. Following the earlier contraceptive efficacy trials using testosterone alone, synergistic combination regimes using newer androgens and other agents are now being tested. The combination of a long-acting testosterone preparation with a progestogen appears to be the most promising, and will hopefully lead to an accepted product for clinical application early in the 21st century.

Androgens↗

Gonadotrophin-releasing hormone agonists for new approaches to contraception in man.

Potent and long-acting stimulatory analogues to the hypothalamic gonadotrophin-releasing hormone (GnRH) were originally developed for profertility purposes. Paradoxically they proved to possess anti-fertility properties. Their anti-gonadal properties are at present being utilized for therapeutic purposes, e.g. contraception, treatment of central precocious puberty and sex steroid-dependent benign and malignant diseases of the reproductive organs, predominantly metastatic prostatic cancer. This review will be limited to the potential use of superactive GnRH agonists for contraception in women and men. Inhibit ion of ovulation by continuous GnRH agonist administration has been studied most extensively and will be dealt with in more detail. Other approaches to interfere with corpus luteum function (induction of in adequate luteal function, luteolysis or early abortion) have so far proved less successful. In males, complete azoospermia has not been consistently achieved by chronic high dose GnRH superagonist therapy alone. Testosterone supplementation is mandatory to avoid the unacceptable side effects associated with GnRH superagonist therapy, namely loss of libido and potency. Thus, to date, inhibition of ovulation by repeated intranasal GnRH agonist administration seems to have the greatest potential as a future contraceptive method. In long-term clinical trials, this new lead to birth control has already proved to provide safe, reliable and reversible contraception in women.

Abortion, Induced↗

Sexuality: sexual activity and contraception during adolescence.

Adolescent sexual activity is increasing. Premature sexual intercourse results in high figures of adolescent pregnancy and abortion, as well as in increased risk of sexually transmitted diseases (STDs). Lack of information on the prevention of STDs and poor hygiene in both boys and girls are also main reasons for increased morbidity because of STDs during adolescence. Contraceptive behaviour during adolescence varies between countries and communities. It seems, however, that the condom and oral contraceptives (OC) are popular contraceptive methods. Ineffective methods such as periodic abstinence, coitus interruptus, and withdrawal before ejaculation are in use. On the other hand, compliance of adolescents on contraception is poor. The above are additional causes for increasing rates of adolescent pregnancies. Countries providing sexual education programs in schools present lower rates of pregnancy and abortion. Adolescent pregnancy is safe if a careful follow up is accepted by the teenager. A significant number of homeless youth are homosexuals or lesbian adolescents. Most of them are at high risk for HIV infection, AIDS, and STDs. It is concluded that sexual education programs are absolutely necessary to offer adolescents the knowledge on the complications of premature sexual activity, as well as prevention of the undesired pregnancy and STDs.

Adolescent↗

Contraceptive choice in Lagos, Nigeria.

Among 1266 contraceptive acceptors (median age 30 years, median parity 4.5) attending a family planning clinic, mostly after referral from the post-natal clinic, two thirds chose the intrauterine device, almost all the remainder choosing oral contraception. Oral contraception was, however, the main choice among women parity 0 or 1. A definite intention to have no more children was given by none of the women of parity 3 or under, and only by 15% of those of parity 8 or more, so that child spacing was the main reason for accepting contraception. By 12 months, the discontinuation rate among oral contraceptive users was 17% (IUD 11%) of which 11% (IUD 6%) was for personal reasons or to plan pregnancy, 4% (IUD 5%) through adverse effects and 0.6% (IUD 0.8%) through accidental pregnancy.

Adult↗

Use of hormonal methods of birth control among sexually active adolescent girls.

OBJECTIVE: To identify factors associated with the use of various birth control methods among sexually active adolescent girls. DESIGN: A survey distributed as part of a larger study measuring compliance with hepatitis B vaccination. SETTING: A hospital-based and a school-based clinic. MEASURES: Demographic and health behavior data including sexual activity, contraceptive method, substance use, condom use, and history of sexually transmitted diseases (STDs) were collected. Birth control method was confirmed by medical record review. Associations with the outcome variable of birth control method were analyzed using chi square, Kruskal-Wallis analyses of variance, and t-tests, followed by logistic regression analysis. RESULTS: Among sexually experienced girls, 39% (n = 123) reported using oral contraceptive pills (OCPs), 5.4% (n = 17) used Depo-Provera (medroxyprogesterone acetate) or Norplant (levonorgestrel), and 55.6% (n = 175) used no hormonal method. Logistic regression analysis revealed that the factors most significantly associated with the use of hormonal methods were older age (odds ratio [OR] = 1.19; 95% confidence interval [CI], 1.07-1.33), not using a condom at last intercourse (OR = 0.55; CI, 0.34-0.90), and having had a well visit within 1 year (OR = 2.11; CI, 1.12-3.70). OCP users were less likely than Depo-Provera or Norplant users to have used alcohol (p = 0.041), cigarettes (p = 0.002), or marijuana (p = 0.018) in the past 30 days. OCP users were less likely than nonusers of hormonal methods to have smoked cigarettes (p = 0.034) or marijuana (p = 0.052). The school-based clinic had a greater proportion of subjects using long-acting progestins (p < 0.001). CONCLUSIONS: The decreased rate of condom use among those who used hormonal birth control methods and the different rates of health risk behaviors among users of various methods require targeted counseling efforts to decrease pregnancy and STD rates among young women.

Adolescent↗

A new era in contraceptive counseling for early adolescents.

In a new era of increased concern about sexually transmitted diseases, the ethical focus of contraceptive counseling for the early adolescent has changed. A discussion of the ethical aspects of contraceptive counseling is included to emphasize contemporary concerns about informed consent and safe contraceptive methods.

Acquired Immunodeficiency Syndrome↗

Acceptability of the long-term contraceptive levonorgestrel-releasing intrauterine system (Mirena): a 3-year follow-up study.

This study investigated the long-term acceptability of a levonorgestrel-releasing intrauterine system (LNG-IUS) in 165 women after 6 and 36 months of use. Changes in menstrual bleeding pattern were experienced by 161 (98%) women, with a cessation or transient absence of menstruation occurring in 75 (47%) and 14 (9%) women, respectively. Amenorrhea was considered by most women (81%) as a positive change. The proportion of women with menstrual pain was reduced from 60% before use to 29% after 36 months of use with the LNG-IUS. Fear of an unwanted pregnancy became less widespread with duration of use and the device had no disturbing effects on the women or their partners during sexual intercourse. The number of women expressing that they were very satisfied with the LNG-IUS was 69% and 77% after six months and 36 months of use, respectively. LNG-IUS is a well-accepted contraceptive method, without negative influences on the sexual relationship between users and their partners, and is suitable for women requiring long-term reversible contraceptive protection.

Adult↗

Multicenter study in Hungary with a 30 micrograms ethinylestradiol- and 150 micrograms desogestrel-containing monophasic oral contraceptive.

Among the countries in Central and Eastern Europe, Hungary has a high oral contraceptive prevalence rate. Until recently, however, Hungarian women have not had access to combined oral contraceptives with new, third-generation progestogens. Marvelon (30 micrograms ethinylestradiol and 150 micrograms desogestrel) was first introduced in 1981 in Western Europe and has, in a number of different studies, proven an effective and well-tolerated oral contraceptive with no effect on blood pressure and a favorable lipid profile. Marvelon was introduced in Hungary in October 1991. Prior to its introduction, a multicenter study was undertaken in Hungary with Marvelon to confirm the clinical results of studies from other countries. The present study confirmed Marvelon to be an effective, well-tolerated combined oral contraceptive with no relevant effect on blood pressure. Remarkable improvements were noted, especially with regard to side-effects, in switchers from other oral contraceptives. It is concluded that Marvelon is a valuable extension of the range of contraceptive methods available in Hungary.

Adolescent↗

Contraception with progestagens in systemic lupus erythematosus.

To test the efficacy and tolerance of progestagens as contraceptives in systemic lupus erythematosus (SLE), 200 mg IM norethisterone enanthate was administered to 10 patients, 0.03 mg/day oral levonorgestrel to 15 patients and they were compared with 18 control patients. There were 4 episodes of active SLE in 48 patient-months on norethisterone enantate and 6 episodes in 122 patient-months on levonorgestrel as compared with 9 episodes of active disease in 298 control patient-months (p = ns). There were no pregnancies and intermenstrual bleeding led to discontinuation of medication in 30% of patients. Progestagens may be an alternative contraceptive method in SLE.

Adult↗

Urinary hormonal profile during the first cycle of low-dose oral contraceptive pills in women.

Ovarian function was studied in ten normal fertile women before and during the first cycle on a low-dose micropill containing 30 mcg ethinyl estradiol and 150 mcg L-norgestrel. In a control cycle and the first treatment cycle, steroid metabolites estrone-3-glucuronide (E1-3G) and pregnanediol-3 alpha-glucuronide (Pd-3G) were measured in daily early morning urine (EMU) samples. Also, luteinizing hormone (LH) was estimated during the expected periovulatory period. During the first cycle of micropill intake, ovarian function was suppressed in all cases. This is evidenced by significantly lower E1-3G and Pd-3G and absent midcycle LH peak compared to control cycles. The pattern of steroid metabolites was almost flat with no peaks. It is concluded that there is no need to cover the first cycle of micropill intake with other contraceptive methods.

Adolescent↗

The effect upon the human vaginal histology of the long-term use of the injectable contraceptive Depo-Provera.

The objective of the study was to evaluate the effect of long-term use of the injectable contraceptive depot medroxyprogesterone acetate (DMPA) on human vaginal histology. Twenty premenopausal women currently using DMPA as a contraceptive method for two and three years were compared with 20 regularly menstruating women, who never used Depo-Provera and/or other kind of hormonal contraceptive in the last 6 months prior to the study. Subjects and controls were matched by age (+/-1 year), body mass index (kg/m2) (+/-1.0), number of pregnancies (+/-1), age at first intercourse (+/-1 year), years of sexual activity (+/-1 year), and number of partners during their life (+/-1). Vaginal biopsies were performed in users at 90+/-7 days after the last injection and in nonusers at day 20-25 of the menstrual cycle. In addition, at the day of the biopsy a blood sample was collected to measure estradiol (in all women) and DMPA in users. The level of serum estradiol was significant lower in Depo-Provera users than in controls (p < 0.001). The thickness of the vaginal epithelium was not smaller among DMPA users than among controls, the mean count of Langerhans cells per mm of epithelium were almost identical in both groups, and no significant differences were found on the vaginal maturation indices. In conclusion, the use of Depo-Provera between two and three years did not affect vaginal thinning of the epithelium, Langerhans cell count or maturation index.

Adult↗

An assessment of abortion services in public health facilities in Mozambique: women's and providers' perspectives.

Complications of unsafe abortion contribute to high maternal mortality and morbidity in Mozambique. In 2002, the Ministry of Health conducted an assessment of abortion services in the public health sector to inform efforts to make abortion safer. This paper reports on interviews with 461 women receiving treatment for abortion-related complications in 37 public hospitals and four health centres in the ten provinces of Mozambique. One head of both uterine evacuation and contraceptive services at each facility was also interviewed, and 128 providers were interviewed on abortion training and attitudes. Women reported lengthy waiting times from arrival to treatment, far longer than heads of uterine evacuation services reported. Similarly, fewer women reported being offered pain medication than head staff members thought was usual. Less than half the women said they received follow-up care information, and only 27% of women wanting to avoid pregnancy said they had received a contraceptive method. Clinical procedures such as universal precautions to prevent infection were less than adequate, in-service training was less than comprehensive in most cases, and few facilities reviewed major complications or deaths. Use of dilatation and curettage was far more common than medical or aspiration abortion methods. Current efforts by the Ministry to improve abortion care services have focused on training of providers in all these matters and integration of contraceptive provision into post-abortion care.

Adolescent↗

Laparoscopic laser sterilisation: an alternative option.

The aim of this prospective study was to evaluate the safety and efficacy of female laparoscopic laser tubal sterilisation. A total of 265 women underwent laparoscopic laser sterilisation as a day-case procedure at Princess Royal University Hospital in Kent between 1996 and 2001. The fallopian tube was divided at the isthmic portion using a neodymium-yttrium aluminium garnet (Nd:YAG) laser probe. All procedures were completed laparoscopically and patients were discharged within 6 h of surgery. No perioperative complications were encountered. The mean follow-up duration was 36 months (range 2 - 7 years) and no intra- or extrauterine pregnancies were reported throughout the entire follow-up period. We conclude that laparoscopic Nd:YAG laser sterilisation appears to be a safe and effective day-case method of female sterilisation. Larger studies with longer follow-up are needed to further define its role as a reliable long-term contraceptive method.

Adult↗