Pharmacokinetics of norelgestromin and ethinyl estradiol delivered by a contraceptive patch (Ortho Evra/Evra) under conditions of heat, humidity, and exercise.

The objectives of this randomized, open-label, three-period, incomplete block design study were to evaluate the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE) delivered by the contraceptive patch, Ortho Evra/Evra, and to evaluate patch adhesion under conditions of heat, humidity, and exercise. During each treatment period, 30 healthy women wore Ortho Evra on the abdomen for 7 days under one of six conditions (normal activity, sauna, whirlpool, treadmill, cool water immersion, or a combination of activities). Blood samples were collected before and several times to 240 hours after patch application. Mean serum concentrations of NGMN and EE generally remained within the reference ranges, 0.6 to 1.2 ng/ml and 25 to 75 pg/ml, respectively, during the 7-day wearperiodfor all activities. Only 1 (1.1%) of 87 patches completely detached spontaneously. Peel force measurements were comparable for all activities. Ortho Evra was well tolerated. In conclusion, Ortho Evra delivers efficacious concentrations of NGMN and EE and maintains adhesive reliability through 7 days of wear even under conditions of heat, humidity, and exercise.

A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and withdrawal bleeding.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. STUDY DESIGN: This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and withdrawal bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. RESULTS: Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. CONCLUSIONS: Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea.

Beyond the exercise prescription: making exercise a way of life.

When we hand a patient a prescription for medication, we may assume that it will be filled and taken as we've instructed. We too often discover later that fears or unanswered questions kept the patient from ever filling the prescription or that side effects led him or her to discontinue its use. And we may never learn what the patient did if he or she wants our approval or fears our response to the truth.

Exercise and menopause: a time for positive changes.

Exercise may help control a number of physical and psychological problems and changes associated with menopause and midlife, including depression, weight gain, loss of muscle mass and bone density, the risk of coronary artery disease, and possibly vasomotor symptoms. The basic prescription of aerobic exercise (20 to 60 minutes 3 to 5 days per week) and strength training (2 to 3 days per week) should be adapted to the patient's medical condition, fitness level, motivation, experience, and preferences. Exercise effects can be supplemented by estrogen therapy, a low-fat diet, and adequate calcium and vitamin D intake.

Exercise for midlife women.

Exercise is good for everyone, but it's more important than ever when you reach midlife. While regular exercise may not eliminate symptoms like hot flushes, it can improve your general well-being and increase your strength and stamina in daily life. If you want to lose fat or maintain a healthy weight, exercise is far more effective than diet alone. A physically active lifestyle, along with good nutrition and estrogen therapy, will also help protect you against heart disease, overweight, and osteoporosis.

An active menopause: using exercise to combat symptoms.

There's no better time than the years surrounding menopause for a woman to start or renew an exercise program. Exercise may reduce the immediate symptoms of menopause, and it decreases the long-term risk of cardiovascular disease, osteoporosis, and obesity. The exercise prescription includes aerobic exercise, resistance training, and stretching components, and should be individualized according to the woman's exercise history.

Prevention of vaginal trichomoniasis by compliant use of the female condom.

BACKGROUND: Several case-control studies suggest that the male condom protects women against some sexually transmitted diseases. The female condom is the first barrier device under the woman's control that may be effective in the prevention of sexually transmitted diseases. GOAL OF THIS STUDY: To determine if appropriate use of the female condom decreased the rate of recurrent vaginal trichomoniasis in previously diagnosed and treated women. STUDY DESIGN: One hundred and four sexually active women with vaginal trichomoniasis were treated with metronidazole and assigned to a group using the female condom or a control group during a 45-day period of continued sexual activity. Fifty women served as controls, and 54 women were assigned to use the female condom. RESULTS: Only 20 women used the female condom each time they had sexual intercourse. Reinfection with trichomonas occurred in 7/50 (14%) controls, in 5/34 (14.7%) noncompliant users, and in 0/20 compliant users of the female condom. CONCLUSION: The compliant use of the female condom is effective in preventing recurrent vaginal trichomoniasis.

PIP: Gynecologists used a single 2 gm oral dose of metronidazole to treat 104 sexually active women (= or 18 years old) for vaginal trichomoniasis as part of a study to determine whether the female condom, when used properly, can protect against reinfection. They counseled the women about the risk of reinfection and to use barrier protection to prevent reinfection. The study took place at urban medical centers in New Haven, Connection; Lose Angeles, California; Chicago, Illinois; and Richmond, Virginia. 50 women, who said they would not use the female condom every time they engaged in coitus during the next 45 days, comprised the control group. Cases were divided into compliant and noncompliant users (N = 20 and 34, respectively). Noncompliant users did not use barrier protection during at least 1 sexual intercourse (mean = 5.1 times). None of the compliant users experienced recurring vaginal trichomoniasis, while 14.7% (5) of noncompliant users and 14% (7) of controls did (p = .09 and .08, respectively). Further, the number of genital contacts (e.g., pre-ejaculatory coitus) before inserting the female condom was much higher in the noncompliant users reinfected with vaginal trichomoniasis than it was in noncompliant users not reinfected (12.25 vs. 4.23; p = .03). In addition, the controls had essentially the same number of unprotected genital contacts as did the noncompliant users (12.1 and 12.25, respectively). These findings suggested that a dose-response relationship exists between female condom use and number of unprotected genital contacts. They also demonstrated that compliant use of the female condom protects against recurrent vaginal trichomoniasis. Further studies should examine whether compliant use of the female condom also protects against gonorrhea, chlamydia, and other sexually transmitted diseases.

Factors associated with withdrawal bleeding after administration of oral micronized progesterone in women with secondary amenorrhea.

OBJECTIVE: To compare two dosages of oral micronized progesterone (P) and placebo for withdrawal bleeding and side effects. DESIGN: Prospective, randomized, double-blind. SETTING: Academic institution. PARTICIPANTS: Out of 190 screened with oligomenorrhea/amenorrhea, 60 who qualified completed the study. INTERVENTIONS: A 10-day course of (1) oral micronized P 300 mg, (2) oral micronized P 200 mg, or (3) placebo. MAIN OUTCOME MEASURES: Withdrawal bleeding, side effects, and changes in lipids. Endogenous estradiol (E2) concentrations at baseline and P concentrations during treatment were correlated with bleeding response. RESULTS: Withdrawal bleeding occurred in 90% of women taking 300 mg, 58% of women taking 200 mg, and 29% of women taking placebo (P less than 0.0002 for 300 mg versus placebo). Side effects occurred similarly among the groups (P = not significant). Lipid concentrations were unchanged. Endogenous E2 and treatment P concentrations were of limited predictive value for withdrawal bleeding. CONCLUSIONS: Progesterone 300 mg induced significantly more withdrawal bleeding than placebo, with similar side effects. Bleeding response cannot be predicted reliably from E2 and P concentrations.

Cervical mucus and serum estradiol as predictors of response to progestin challenge.

The present study was undertaken to assess the correlation between and relative predictive value of each of the following variables and progestin-induced withdrawal bleeding: cervical mucus appearance, serum E2 level, patient age, duration of amenorrhea, smoking and exercise habits, and body composition. Of 120 oligomenorrheic and amenorrheic women evaluated, only cervical mucus appearance and serum E2 level were significantly associated with response to progestin challenge. A multivariate logistical regression analysis showed cervical mucus to be the most predictive variable followed by serum E2 level. No absolute E2 level was found to discriminate between those who did and those who did not have withdrawal bleeding after progestin challenge. These data suggest that office examination of cervical mucus may be a useful indicator and guideline in planning therapy.

Exercise in the menopausal woman.

An exercise program for menopausal women that includes both aerobic and resistance training may prevent or relieve problems such as cardiovascular disease, obesity, muscle weakness, osteoporosis, and depression. The risk of cardiovascular disease increases in women after menopause; in both men and women, regular aerobic exercise may improve cardiorespiratory endurance and reduce the risk of cardiovascular disease. Aerobic exercise also prevents some age-related increases in body fat and it elevates resting metabolic rate, which correlates directly with lean body mass. Inactivity, not hormonal change, is the most common cause of obesity. Resistance training can improve muscle strength and bone density. Increases in bone mineral content have been found at lumbar vertebral and distal radial sites in women who participate in exercise programs. Weight-bearing exercise in conjunction with estrogen replacement therapy and calcium supplementation helps to prevent osteoporosis. Many women experience mood changes at menopause. Some of these symptoms are caused by chronic sleep deprivation due to night flushes and respond best to estrogen; others are related to levels of brain chemicals and respond favorably to exercise.

Relationship between menarcheal age and adult height.

Many factors contribute to the attainment of adult height, including genetic and environmental variables. To assess the relationship between menarcheal age and adult height, measured adult height and recalled menarcheal age were compared by regression analysis in 425 women. The overall regression equation, Height = 158.14 + .4321 (Age) - .1667 (Age - 13)2, was significant (P less than .003), as was the coefficient for the quadratic term (P not equal to .014). After exclusion of those in whom menarche occurred after age 16, the overall linear regression equation for the remaining 416 patients, Height = 153.95 + .7353 (Age), was still significant (P not equal to .001), but the coefficient for the quadratic term was not. These data suggest that menarcheal age significantly correlates with adult height as an independent variable.

Exercise during pregnancy: current state of the art.

Women should be encouraged to become fit before they become pregnant. During pregnancy, those who were accustomed to aerobic exercise before pregnancy can probably continue their sports involvement throughout pregnancy, at the same perceived level of exertion. Weight training and calisthenics are advisable during pregnancy, even for those who never practised them before. Pregnant women should avoid high intensity, prolonged duration, hyperthermia, dehydration, abdominal trauma, and low oxygen availability in exercise.

Gynecological concerns in young and adolescent physically active girls.

Young girls should be advised to develop the regular exercise habit and to maintain it throughout life. Prepubertal athletes are more likely than their sedentary friends to experience menarcheal delay. Postmenarcheal athletes have increased susceptibility to oligomenorrhea and amenorrhea. Athletes with delayed puberty deserve examination and possibly further evaluation. Adolescent athletes with oligomenorrhea or amenorrhea deserve examination and hormonal evaluation. Hormonal replacement therapy is unnecessary prior to age 16, is optional between ages 16 and 18, and is recommended after age 18.

How I Manage Exercise-Related Menstrual Disturbances.

In brief: All women who stop menstruating or menstruate irregularly should be examined. Amenorrhea and oligomenorrhea are often related to heavy exercise, but in athletes as well as nonathletes these conditions can signal a serious pathologic condition. Even athletes with regular periods can experience hormone alterations, short luteal phase, or anovulation. Anovulation and hypoestrogenism are the two major conditions experienced by women with oligomenorrhea and amenorrhea. Anovulation may lead to endometrial pathology and an increased risk of breast cancer, while hypoestrogenism increases the risk of developing osteoporosis. Tests to pinpoint the causes of menstrual dysfunctions and measure estrogen levels are listed, and treatments to establish a proper balance of estrogen and progesterone are described.

Causes, evaluation, and management of athletic oligo-/amenorrhea.

Oligomenorrhea and amenorrhea are more common among athletes than among the general population. Although these conditions in athletes are often related to exercise and thinness, they may be caused by serious pathology too. All athletes with menstrual dysfunction deserve thorough evaluation and most need treatment.

Menstrual disturbances in the athlete.

Women should be encouraged to exercise. Those who develop menstrual problems should be thoroughly evaluated to detect any serious causes and should be treated to prevent any serious results. The importance of exercise in the lifestyle of female athletes should be respected.