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PubMedDate not supplied

Clinical evidence of the minimal androgenic activity of norgestimate.

The goal in improving the progestational component of oral contraceptives (OCs) is to enhance the selectivity of the progestin by achieving a high degree of contraceptive efficacy while decreasing undesirable side effects associated with existing progestational agents. The androgenic activity of current progestins results in changes in lipid metabolism, particularly decreased levels of high-density lipoprotein cholesterol (HDL), which have been associated with an increased risk of coronary heart disease (CHD). A progestin with high antiovulatory activity and minimal androgenicity would offer a clear therapeutic advantage in oral contraception. Norgestimate (NGM) is a new progestin with a unique profile of biological activity that has demonstrated a high level of selectivity in preclinical assays. The present studies were conducted to confirm clinically the low androgenic activity of NGM. Norgestimate (0.25 mg) in combination with 0.035 mg ethinyl estradiol (NGM 0.25/35) was compared with 0.30 mg norgestrel combined with 0.030 mg ethinyl estradiol (Lo/Ovral) in two multicenter clinical studies. In the first study (1,261 women), HDL levels were significantly increased from baseline levels in NGM 0.25/35 subjects but were significantly decreased in Lo/Ovral subjects. Increases in low-density lipoprotein cholesterol (LDL) levels were moderate in the NGM 0.25/35 group and pronounced in the Lo/Ovral group. A favorable lipid profile in NGM 0.25/35 subjects was also reflected in the LDL/HDL ratios, which were significantly lower in the NGM 0.25/35 subjects than in the Lo/Ovral subjects. Sex hormone binding globulin (SHBG) binds androgens, preventing clinical expression of androgenic activity. As a result, elevations in SHBG levels reduce bioactive (unbound) androgen levels and decrease the potential for androgenic side effects.(ABSTRACT TRUNCATED AT 250 WORDS)

Acne Vulgaris↗
PubMed1989

A multicenter clinical evaluation of a new monophasic combination: Minulet (gestodene and ethinyl estradiol).

The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.

Adolescent↗
PubMed1980

Household distribution of contraceptives in rural Egypt.

Oral contraceptives were offered to all married, fecund women 15-44 years of age living in 38 Egyptian villages with a population of 200,000. Before the household distribution, contraceptive prevalence was 19.1 percent. Nine months after the distribution, the contraceptive prevalence increased to 27.7 percent, a relative increase of 45 percent. Based on this study, a modified delivery system is currently being tested on a governoratewide basis. The modified system will include a wider range of fertility regulation methods and will also have health and community development components.

Adolescent↗
PubMed1990

Gastrointestinal disease and oral contraception.

Oral contraceptive steroids play a major role in modern family planning. With the present tendency to decrease the doses of both estrogens and progestogens, any factor that reduces the bioavailability of the lower-dose preparations may have an impact on contraceptive protection. Although ethinyl estradiol, the most commonly used oral estrogen, is liable to an enterohepatic circulation as unchanged drug, the commonly used progestogens are not. At present, no convincing evidence exists in the human subject that disruption of the enterohepatic circulation by antibiotics or antacids does reduce contraceptive efficacy of the pill. Oral contraceptive steroids are mainly absorbed from the small bowel, and contraceptive efficacy depends on its absorptive capacity. Enhanced passage of gastrointestinal contents or impaired absorption may thus contribute to contraceptive failures in patients who have chronic inflammatory disease, diarrhea, ileostomy, or jejunoileal bypass.

Antacids↗
PubMed1988

Menarche, menstruation, sexual relations and contraception of adolescent females with Down syndrome.

Fifteen female adolescents with Down syndrome (DS) and 33 female controls without this syndrome were surveyed on age of menarche, menstruation, sexual relations and contraception. All probands and controls were born between 1 January 1965 and 31 December 1970. The day of census was December 31, 1985. All probands and controls were living permanently in the Danish county of Aarhus on this day. Persons close to the DS patients (parents/foster-parents/permanent staff) were interviewed on the above-mentioned topics. All controls were interviewed themselves. The average age of menarche was 13.6 years for probands and 13.5 years for controls. The average duration of the bleeding was 5.5 days for probands and 5.4 days for controls. The average length of the cycle was 28.3 days for probands and 28.6 days for controls. Thirteen DS patients had not had sexual intercourse (no information was available for 2 probands). Twenty-four controls had and 9 had not had sexual intercourse. There is a significant difference between probands and controls concerning use of oral and other contraceptives.

Adolescent↗
PubMed1996

Depot medroxyprogesterone acetate versus an oral contraceptive combined with very-low-dose danazol for long-term treatment of pelvic pain associated with endometriosis.

OBJECTIVE: Our purpose was to evaluate the efficacy and safety of depot medroxyprogesterone acetate versus an oral contraceptive combined with very-low-dose danazol in the long-term treatment of pelvic pain in women with endometriosis. STUDY DESIGN: Eighty patients with endometriosis and moderate or severe pelvic pain were randomized to treatment for 1 year with intramuscular depot medroxyprogesterone acetate 150 mg every 3 months or a cyclic monophasic oral contraceptive (ethinyl estradiol 0.02 mg, desogestrel 0.15 mg) combined with oral danazol 50 mg a day for 21 days of each 28-day cycle. The women were asked to grade the degree of their satisfaction at the end of therapy. Variations in severity of symptoms during treatment were determined by a 10 cm visual analog and a 0- to 3-point verbal rating scale. RESULTS: Twenty nine of 40 subjects (72.5%) in the depot medroxyprogesterone acetate group were satisfied after 1 year of therapy compared with 23 of 40 (57.5%) in the oral contraceptive plus danazol group (chi 2(1) = 1.37, p = 0.24, odds ratio 1.95, 95% confidence interval 0.76 to 4.97). A significant decrease was observed in all symptom scores in both study groups. At 1-year assessment dysmenorrhea was significantly greater in women allocated to oral contraceptive plus danazol. CONCLUSION: Depot medroxyprogesterone acetate seems to be an effective, safe, and convenient low-cost treatment for pelvic pain associated with endometriosis. However, women should be carefully counseled regarding menstrual changes and the potential prolonged delay in the return of ovulation.

Adolescent↗
PubMed1989

Oral contraceptives and breast cancer: results from an expanded case-control study.

The relationship between oral contraceptives and breast cancer was evaluated among 2,022 cases and 2,183 controls participating in a multicentre breast cancer screening programme. Ever use of oral contraceptives was not related to breast cancer risk (RR = 1.0, 95% CI 0.9-1.2), and no overall patterns of increasing or decreasing risks were observed according to the duration of use, or time since first or most recent use. Although we had no women with extended periods of oral contraceptive use early in life, no evidence of adverse effects attributable to short-term use before age 25, before first live birth or during the perimenopausal period were observed. Further, oral contraceptives did not interact with other breast cancer risk factors, except among those with a history of two or more breast biopsies (RR = 2.0). Analyses by stage of disease revealed that risk was related to the duration of oral contraceptive use: greater than or equal to 5 years use was associated with reduced risk for in situ cancer (RR = 0.59) and increased risks for invasive cancers (RR = 1.5 and 1.4 respectively for small and large lesions). These data suggest that oral contraceptive effects may vary by stage of disease, but provide no overall evidence of an association between oral contraceptives and breast cancer.

Adult↗
PubMedDate not supplied

Oral contraceptives and antibiotics: important considerations for dental practice.

This paper considers the possible interactions between oral contraceptive pills and antibiotics, in the context of modern dental practice. A review of the literature on such interactions leads to the conclusion that current national guidelines on the use of alternative contraceptive measures during a course of broad spectrum antibiotics in women also using the oral contraceptive pill should be emphasised and encouraged as part of good clinical practice. A patient information leaflet may be considered as a useful way of presenting such advice to female patients.

Anti-Bacterial Agents↗
PubMedDate not supplied

A scale to measure microbehaviors of oral contraceptive pill use.

The ways in which contraceptive methods are actually used is of increasing interest to researchers, clinicians, and policy makers. Although contraceptive "use" has multiple dimensions, existing indicators measure only one aspect of use or combine unidimensional measures to produce a questionable pastiche. This study uses a subsample of 612 respondents from a larger study of first-time patients at a public-health-department family planning clinic to develop a new measure. Psychometric properties of this measure are examined and discussed.

Contraception Behavior↗
PubMed1990

HIV infection among lower socioeconomic strata prostitutes in Nairobi.

A cohort of 418 lower socioeconomic strata prostitutes were enrolled in a study of the epidemiology of sexually transmitted diseases (STDs) between January and April 1985. Sixty-two per cent of the women were seropositive for HIV infection at enrollment. Significant associations were found between HIV seropositivity and Tanzanian origin (OR = 2.12, CI 95% = 1.18-3.81, P less than 0.03), younger age, a shorter duration of prostitution, reduced fecundity, use of oral contraceptives (OR = 1.8, CI 95% = 1.1-2.9, P less than 0.05) and genital ulcer disease (OR = 3.32, P less than 0.00001). No associations were noted with other STD. Stepwise logistic regression analysis confirmed independent associations between HIV infection and Tanzanian origin (OR = 2.27, CI 95% = 1.25-4.14, P less than 0.007), reduced fecundity (OR = 0.83, CI 95% = 0.74-0.94, P less than 0.003), oral contraceptive use (OR = 2.02, CI 95% = 1.22-3.35, P less than 0.006) and duration of prostitution (OR = 0.39, CI 95% = 0.23-0.65, P less than 0.004). Oral contraceptives may increase susceptibility to HIV or may be a marker for other factors which increase risk of acquisition. Further studies are necessary to confirm this association.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Relationship between contraceptive method choice and beliefs about HIV and pregnancy prevention.

BACKGROUND AND OBJECTIVES: The goal of this study was to examine the relationship between contraceptive method choice and perceptions of HIV and pregnancy risk among women at risk of HIV infection and transmission. STUDY DESIGN: Women who were infected with HIV or who were at high risk of infection were administered a questionnaire assessing sexual and drug-related HIV risk behaviors and beliefs, STD and pregnancy history, and intentions, beliefs and behaviors regarding pregnancy, childbearing and contraception. RESULTS: Among women who reported using a contraceptive method every time they had intercourse, 43% used condoms only, 22% used birth control pills only, and 11% used both. Only 58% of consistent condom users believed they were very unlikely to become infected with HIV in the next year. Controlling for risk factor differences, pill-only users were less likely to believe themselves at risk of HIV infection, and more confident in their ability to prevent HIV infection, compared with condom-only users. CONCLUSION: Results suggest that women's beliefs about the effectiveness of a method for pregnancy prevention may generalize to beliefs about the efficacy of the method for disease prevention.

Adult↗