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PubMed1991

Clinical experience with a new norgestimate-containing oral contraceptive.

Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.

Adult↗
PubMedDate not supplied

A consumer intercept study of oral contraceptive users in the Dominican Republic.

Purchasers of a low-cost oral contraceptive were intercepted and interviewed in a sample of Santo Domingo pharmacies that represented the highest sales of the product, yet also reflected the socioeconomic profile of the city's entire population. Users of the contraceptive were later interviewed in greater depth in their homes. The survey of users showed that the Dominican Republic's social marketing program, implemented by PROFAMILIA, was reaching an appropriate target market--that is, younger, lower-middle-class women of low parity. The program was, in addition, successful in attracting first-time adopters, and it was also expanding the overall commercial market for all contraceptives. The marketing campaign was successful in part because a mass audience was reached, through brief television spots. Program impact on contraceptive prevalence can be assessed from sales data.

Adolescent↗
PubMed1987

Pill method failures.

This is a study over a four year period from November 1981 to December 1985 documenting 163 cases of pill method failures in reliable pill takers. In over one third of these cases (36%) there were no predisposing factors. Significant factors which were associated with failure were diarrhoea and/or vomiting in 35%, and breakthrough bleeding on the combined pill in 21%. While there is controversy in the literature about the role of antibiotics in causing pill failure, this study found 23% of failures associated with antibiotic use. Two failures occurred on anticonvulsant medication. Recommendations are made for improved instructions to patients.

Abortion, Induced↗
PubMed1994

Past and present contraceptive behavior of new Soviet immigrant women in Israel.

This exploratory research investigated past and current use of contraceptives among a purposive sample of 117 new immigrant women from the Commonwealth of Independent States (former Soviet Union). The findings confirm the widespread use of induced abortion (IA) as a method of birth control before immigration. Fifty-eight percent of the sample had had at least one IA, and the average was 2.7 IA. The most commonly used types of contraception before immigration were the pill, safe days, withdrawal, and the IUD. Currently used types of contraception were the IUD, safe days, withdrawal, and condoms; however only 45% of the sample were currently using any type of contraception. Of particular interest were the relatively high reported use of the pill before immigration and low current use, and the former low level of condom use and its increase in popularity in Israel. Despite the availability of more effective methods of birth control, safe days and withdrawal remain commonly used. The high cost of the pill was mentioned as a deterrent to its current use. Despite the high prior level of IA, the majority of women in this sample (84%) preferred today to use other birth control methods, and would like the opportunity to receive professional advice. These findings support the need for educational efforts directed toward new immigrant women from CIS.

Abortion, Induced↗
PubMed1996

Acceptability and discontinuation of Depo-Provera, IUCD and combined pill in Kenya.

This paper reports on a prospective study conducted between June 1990 and June 1992 to determine method acceptability, user satisfaction and continuation rates for three highly effective and reversible contraceptive methods currently available in Kenya: the CuT 380A (IUCD), the injectable, Depo-Provera and the low-dose oral contraceptive pill, Microgynon. A non-randomised sample of volunteer participants was used. One thousand and seventy-six users were followed up for a period of one year or up to the time of discontinuation of the method, whichever came earlier. Analysis revealed method specific differences in users' characteristics. The OC users were younger and had fewer children than the IUCD or Depo-Provera users. The Depo-Provera users were older, and had the largest family sizes. Many OC users (almost 40%) were single, while almost three-quarters of IUCD and Depo-Provera users were married. IUCD users were also more educated compared to OC and Depo-Provera users. Survival analysis was used to calculate cumulative life table discontinuation rates by method for the 12 month period. Discontinuation rates were highest for OC users (80%) and lowest for IUCD users (20%) and intermediate for Depo-Provera users (39%). Ninety percent of OC and Depo-Provera users and 86% of IUCD users said they were satisfied with their respective methods. While OCs are among the most popular family planning methods in Kenya, they are also one of the most problematic, while IUCD has the fewest compliance problems. Service providers need to address the issue of high discontinuation rates among the young OC users.

Adolescent↗
PubMed1992

Contraception after heart surgery.

This study represents the different methods of contraception used by women having cardiac surgery at Ain Shams University Hospital. The study comprised of 250 women having had mitral commissurotomy, 77 women having had valve replacement including one case of triple valve repair and 3 women having had cardiac surgery for congenital heart disease. An IUCD was used by 170 women (51.5%), vaginal tablets by 4 women (1.2%), oral contraceptive pills by 7 women (2.1%), "safe period" by 7 women (2.1%), tubal ligation was performed in 10 women (3%). The husbands of 33 women (10%) used condoms, and 99 women (30%) did not use contraceptive methods. The IUCD was tolerable and was associated with bleeding in 60 women (35.2%) and leucorrhoea in 55 (32.3%). The IUCD was removed from only one woman due to severe bleeding. Three pregnancies occurred with condom users in two women who had had mitral commissurotomy and one having had valve replacement. There was no case of bacterial endocarditis in the study group.

Abortion, Spontaneous↗
PubMed1993

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

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

Adolescent↗
PubMed1991

Hereditary and environmental influences on blood pressure values of premenopausal women and their college-age daughters.

Blood pressure (BP) and environmental (dietary/lifestyle) variables were measured in 62 healthy normotensive pairs of premenopausal mothers (44.3 years) and their college-age consanguineous daughters (18.7 years) to estimate the relative contributions of genetic vs environmental factors on BP. As expected, the mothers had significantly higher systolic (SBP) and diastolic (DBP) blood pressures than the daughters (p less than 0.004 and 0.012, respectively). Among the dietary/lifestyle variables measured, mothers were found to have significantly higher mean weight and body mass index (BMI) (p less than 0.009 and 0.001, respectively), and significantly lower lean body mass (LBM) and calcium intake than their daughters (p less than 0.003 and 0.037, respectively). Significant correlations were found between mean BP of the mothers and their mean weight and BMI. No significant correlations existed for the daughters. The familial resemblances between BP of the mothers and daughters were relatively low, i.e., 0.14 for SBP and 0.19 for DBP. From these findings we conclude that the higher BP values with increased age among this healthy female population primarily result from an increase in BMI and a shift from lean to fat mass, as measured by midarm circumference. Our results suggest that environmental factors, i.e., excessive energy intake over time, accompanied by decreased physical activity, are primarily responsible for the greater indices of body fat and the higher BPs observed in this sample of healthy premenopausal women.

Adipose Tissue↗
PubMed1991

Breast cancer risk and oral contraceptive use: results from a large case-control study.

The association between oral contraceptive use and breast cancer risk was examined using data from a case-control study of breast cancer in Long Island, New York. Cases were defined as female residents of Nassau and Suffolk Counties between the ages of 20 and 79, diagnosed with breast cancer between January 1, 1984 and December 31, 1986. Age- and county-matched controls were selected from driver's license files. Among all women under age 70 at diagnosis, there was no association between oral contraceptive use and breast cancer; there was, however, a positive association in the subgroup ages 20-49 (adjusted odds ratio = 1.68, 95% CI: 1.16-2.42). Risk increased with increasing duration of use, but did not differ between women who first used oral contraceptives before the first pregnancy and those who first used them later, or between women who first used oral contraceptives before age 25 and those who first used them at a later age. Risk also appeared to increase with number of years of use before the first pregnancy or before age 25, although numbers were small. History of benign breast disease did not influence risk. The association of breast cancer risk with oral contraceptive use appeared stronger in women from Suffolk County than Nassau County.

Adult↗
PubMedDate not supplied

Factors related to infertility in the United States, 1965-1976.

Although the overall rate of infertility among American women of reproductive age remained fairly constant between 1965 and 1976, the percentage of young black women who were infertile increased very sharply. In 1976, 18% of black women of reproductive age were infertile, whereas only 9% of white women of the same age were infertile. With use of national data bases, the relationships between sexual activity, complications of pregnancy, sexually transmitted diseases, pelvic inflammatory disease, use of contraception, and infertility were examined. Available evidence shows a strong association between sexually transmitted diseases, pelvic inflammatory disease, and infertility trends. Our projections indicate that sexually transmitted diseases operating through pelvic infections account for much of the race differential in infertility as well as for one-half to one-third of the increase. In 1976 5-8% of 20-29-year-old black women were estimated to suffer infertility attributable to sexually transmitted diseases. Among white women the estimated incidence of infertility caused by sexually transmitted diseases was 0.7-1%.

Adolescent↗
PubMed1990

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↗