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Biomedical subjects

S A Pasquale

Publications and source records attributed to S A Pasquale.

At least 19 recordsLinked to original sources
PubMed1998

The effect of fluconazole on circulating ethinyl estradiol levels in women taking oral contraceptives.

OBJECTIVE: This open-label, two-period, crossover study was conducted to evaluate the effect of a single 150 mg dose of fluconazole on the pharmacokinetics of ethinyl estradiol in healthy female subjects. STUDY DESIGN: Ten subjects regularly taking Ortho-Novum 7/7/7 (Ortho Pharmaceutical, Raritan, N.J.) and 10 subjects regularly taking Triphasil (Wyeth-Ayerst Laboratories, Philadelphia), which contain ethinyl estradiol 35 microg and 30 microg during days 1 to 6, respectively, were randomly assigned to receive a single 150 mg dose of fluconazole 2 hours before the oral contraceptive, on pill day 6 of one of two menstrual cycles. Ethinyl estradiol serum concentrations were measured at baseline and up to 24 hours after oral contraceptive intake. No fluconazole was administered during the other menstrual cycle, which served as the control. RESULTS: Mean serum concentrations of ethinyl estradiol were increased after fluconazole administration in both oral contraceptive groups. Maximum observed serum concentration and area under the concentration-time curve values were significantly (p < 0.05) greater during the fluconazole regimens (vs regimens without fluconazole) for both oral contraceptive groups and for combined values of the two oral contraceptive groups. The mean time to reach the maximum concentration was not altered by concomitant fluconazole administration. CONCLUSIONS: These findings suggest that there is a potential for a clinically significant interaction between coadministration of fluconazole and ethinyl estradiol in oral contraceptives.

Adult↗
PubMed1997

Lack of interaction between magnetic resonance imaging and the copper-T380A IUD.

To determine if the CuT380A (ParaGard) IUD is affected by magnetic resonance imaging (MRI), in vitro studies utilizing a CuT380A IUD (ParaGard), a copper-bearing IUD, and a Signa 1.5T HR system were used to evaluate whether the dynamic magnetic forces generated by the MRI resulted in movement, torque, or heat when the IUD was exposed to the magnetic field generated by the MRI. There was no deflection, turning motion (torque), or temperature change when the IUD was exposed to a magnetic field. There appears to be no reason to exclude women with IUDs of the type examined from an MRI system or its environs.

Adult↗
PubMed1997

Peripheral progesterone (P) levels and endometrial response to various dosages of vaginally administered P in estrogen-primed women.

OBJECTIVE: To compare the pharmacokinetics and pharmacodynamics of 100 mg/d, 200 mg/d, and 400 mg/d (200 mg two times per day) of P administered vaginally for 14 days to estrogen-primed postmenopausal women. DESIGN: Randomized, open-label, three-way crossover study. SETTING: Two university-based investigative sites. PATIENT(S): Twenty healthy postmenopausal women with histologically normal endometria. INTERVENTION(S): Oral 17 beta-E2 was given each day of a 28-day cycle; a P vaginal suppository was inserted daily according to the randomization schedule during days 15-28 of each cycle; blood samples were collected; an endometrial biopsy was obtained on day 25; and patients were crossed over to the next treatment cycle after a washout period of at least 30 days. MAIN OUTCOME MEASURE(S): Mean P blood levels, endometrial dating/conversion. RESULT(S): There was good vaginal absorption of P for all dosages. Endometrial conversion occurred in all 200- and 400-mg/d P-dosed cycles, whereas the 100-mg/d dosage failed to convert primed endometria consistently. There also was a significantly increased tendency for earlier bleeding and spotting with the 100-mg/d dosage. CONCLUSION(S): Both the 200- and 400-mg/d dosage regimens consistently convert an estrogen-primed endometrium, and yield appropriate endometrial dating and bleeding patterns. However, the 400-mg/d dosage attains the highest sustained blood levels and may be the best dosage regimen for further study.

Administration, Intravaginal↗
PubMed1994

Irregular bleeding, body mass index and coital frequency in Norplant contraceptive users.

Seventy-five women with a mean age of 27.5 years who requested Norplant implants for contraception were studied over a five-year period. The patients kept daily diaries of their vaginal bleeding and coital frequency, and were seen at least every six months at which time their weight was measured. This study examines the impact of Norplant implants use on menstrual regularity, body mass index and coital frequency. Irregular bleeding was most prevalent during the first two years of Norplant implants use and accounted for the primary reason for discontinuation of this method. No increase in Body Mass Index (BMI) was noted in Norplant implants users over the five-year study period. Women with irregular bleeding did not have a higher or lower BMI compared to women with regular bleeding and irregular bleeding patterns did not impact on coital frequency. Over five years, four pregnancies occurred during Norplant implant use. Norplant implants are a highly effective contraceptive method and women using this method should not expect an increase in body weight. Irregular bleeding is most frequent during the first two years of use and menstrual cyclicity resumes in the majority of women by the third year of use and continues to the fifth year of use.

Adult↗
PubMed1992

Future directions in contraception.

Although contraceptive research has markedly decreased in the United States, it has continued in other countries. The emphasis has been on the development of long-acting, noncoitally related contraceptives, including the progestogen-only and progestogen-estrogen vaginal rings. The levonorgestrel-releasing intrauterine device is highly effective and, like other contraceptives, may contribute to a decrease in the incidence of pelvic inflammatory disease. There is a great need for more effective, acceptable barrier contraceptives. The vaginal condom does not appear to be acceptable to many couples. Studies continue to demonstrate couples' lack of adherence to plans for abstinence and poor utilization of the present barrier contraceptives. The potential for the development of a male contraceptive utilizing gonadotrophin hormone-releasing hormone agonists or antagonists in conjunction with testosterone may hold promise in the future.

Contraception↗
PubMed1989

Oral contraceptives: significance of their effects in man and relationship to findings in animal models.

Combination oral contraceptives have been available since 1960. They contain both an estrogen and a progestogen and have been studied extensively in both lower animals and humans and have been the subject of special regulatory requirements for toxicological and clinical studies. The initial oral contraceptives, by today's standards, contained very high levels of both hormones. There has been a continuous decrease in the dose of both the estrogen and the progestogen during the past quarter century, with continued maintenance of high degree of effectiveness. This decrease of dosage has been stimulated by findings from prospective clinical trials and retrospective case control trials. As additional information has been gained with oral contraceptives, new benefits beyond their effectiveness as contraceptives have been realized. Today's oral contraceptives provide a high degree of effectiveness, low incidence of nuisance side effects, and low incidence of major adverse effects.

Animals↗
PubMed1988

A double-blind, placebo-controlled study comparing three single-dose regimens of piroxicam with ibuprofen in patients with primary dysmenorrhea.

Sixty-eight women with primary dysmenorrhea were randomly assigned to one of five four-times-daily treatment groups for a minimum of three days and a maximum of five days. Three of the groups received different initial single-daily doses of piroxicam, which were followed on each treatment day with placebo for the second through fourth doses, namely, piroxicam 20 mg daily for five days (piroxicam 20 mg for five days); piroxicam 40 mg on Day 1, followed by piroxicam 20 mg on Days 2 through 5 (piroxicam 40 mg for one day); and piroxicam 40 mg on Days 1 and 2, followed by piroxicam 20 mg on Days 3 through 5 (piroxicam 40 mg for two days). The fourth group received ibuprofen 400 mg four times per day, and the fifth group received placebo four times per day. Patients determined the severity of overall discomfort and pelvic-abdominal pain at baseline and prior to each dose using a four-point numerical scale. Supplemental ibuprofen, 400 mg four times per day, was provided for those patients requiring additional pain relief. Patients also made a global determination of overall relief at the end of the study. At 24 hours, the results revealed that piroxicam 40 mg for two days, piroxicam 20 mg for five days, and ibuprofen provided significantly more relief of overall discomfort compared with placebo (p = 0.003, p = 0.018, and p = 0.026, respectively). All four active treatment groups also experienced significantly more relief of pelvic-abdominal pain compared with placebo: piroxicam 40 mg for two days followed by three days of 20 mg (p = 0.002), piroxicam 40 mg for one day followed by four days of 20 mg (p = 0.023), piroxicam 20 mg for five days (p = 0.012), and ibuprofen (p = 0.011). A significantly smaller percentage of patients treated with piroxicam 40 mg for two days required supplemental medication as compared with those treated with piroxicam 20 mg for five days (p = 0.035) and patients treated with placebo (p = 0.010). A greater amount of overall relief was obtained by patients treated with piroxicam 40 mg for two days compared with patients treated with piroxicam 40 mg for one day (p = 0.041) and placebo-treated patients (p = 0.001). It was concluded that single daily doses of piroxicam 20 mg and 40 mg were as effective as ibuprofen, 400 mg four times per day, for the relief of primary dysmenorrhea.

Abdomen↗
PubMed1987

Norplant contraceptive implants: rods versus capsules.

Norplant contraceptive implants are silastic implants containing levonorgestrel. When placed subcutaneously in the medial aspect of the upper arm, they release low levels of levonorgestrel in a constant manner over an extended period of time. Comparative studies of two silastic rods versus six capsules containing levonorgestrel were studied in 250 subjects for 4,464 months of use. Only one pregnancy occurred during the study. Side effect patterns were similar in both groups; the major side effect being irregular uterine bleeding. The bleeding, however, was well tolerated by subjects in both groups and discontinuation rate was very low. The two-rod system offers the advantages of easier insertion technique and shorter insertion time as well as ease of removal as compared to the six-capsule system. Norplant contraceptive implants offer a highly effective means of contraception which is particularly suited for women who are concerned about failure and compliance with oral contraceptives. This type of contraception should become well accepted, not only in underdeveloped countries, but in developed countries as well.

Adolescent↗
PubMed1986

Rationale for a new triphasic oral contraceptive.

The association of progestogen and estrogen with certain undesirable effects led investigators to seek oral contraceptive (OC) formulations containing reduced amounts of both. Evidence is presented from studies of the triphasic regimen of 0.5 mg norethindrone plus 35 micrograms ethinyl estradiol on the first seven menstrual cycle days, 0.75 mg norethindrone plus 35 micrograms ethinyl estradiol the second seven days, followed by 1 mg norethindrone plus 35 micrograms ethinyl estradiol for the final seven days. This OC formulation appears to be highly effective and relatively free of the side effects commonly associated with low-dose OC regimens.

Contraceptives, Oral, Combined↗
PubMed1984

Evaluation of drugs for arrest of premature labor in a new animal model.

Reported are pharmacologic data from a new animal model used for evaluating drugs from several therapeutic classes for their potential use in the treatment of premature labor. This model measures the spontaneous delivery time between the first and second rat pups in a term pregnancy. In control animals, this averaged 16.3 +/- 4.2 minutes. Ethanol (3.5 gm/kg) and the beta-agonists ritodrine (12.5 mg/kg) and albuterol (0.25 mg/kg) significantly delayed delivery of the second pup. The calcium blockers nifedipine, verapamil, and diltiazem were the most active of all compounds tested in this model. The nonsteroidal anti-inflammatory agents indomethacin and naproxen were inactive at doses as high as 5 and 25 mg/kg, respectively. Metiamide, an H2-antagonist, and dimenhydrinate, an H1-antagonist, were inactive.

Albuterol↗
PubMed1983

Amenorrhea associated with carotenemia.

Data are presented for ten women with anovulation, nine of them with amenorrhea, who have associated carotenemia. Classic explanations for carotenemia in amenorrheic patients have been weight loss or anorexia nervosa, yet carotenemia in our patients appeared to be diet induced. All patients consumed a pure or predominantly vegetarian diet; there was no intake of red meats. Clinical and laboratory data of the patients are presented. The amenorrhea of the patient is consistent with hypothalamic hypogonadotropic anovulation (HHA). It appeared that diet modification not only led to reduction in carotene levels, but also improved the menstrual status. The association of carotenemia and menstrual disorders is reviewed. The possibility that carotenemia is related to the development of HHA is discussed.

Adolescent↗
PubMed1982

Results of a study to determine the effects of three oral contraceptives on serum lipoprotein levels.

A multicenter, double-blind investigation with random allocations of subjects to Ortho-Novum 1/50 tablets, Ortho-Novum 1/35 tablets, or Modicon tablets (Ortho Pharmaceutical Corporation, Raritan, NJ) was conducted. Each subject remained on the same oral contraceptive (OC) for at least four cycles. Serum high-density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglyceride, and cholesterol were measured prior to the initiation of OC therapy and were repeated after treatment cycles 2 and 4. There were no significant changes in HDL, LDL, or serum cholesterol levels. Triglyceride levels increased but remained significant only with the lowest dose product. These were no significant differences among the three drugs for the four parameters studied.

Adolescent↗
PubMed1979

Optimum dosage of an oral contraceptive. A report from the study of seven combinations of norgestimate and ethinyl estradiol.

A statistically designed study was carried out to determine an optimum combination of norgestimate and ethinyl estradiol as an oral contraceptive, based on efficacy, safety, and side-effect patterns. A total of 1,991 patients were studied for more than two years while they were receiving various dosage combinations of these steroids. There were seven dosage combinations studied as part of a statistically orthogonal experimental design, augmented by three combinations near the center. The data arising from these studies were used to fit approximate functions relating the amount of norgestimate and ethinyl estradiol to the rate of spotting and breakthrough bleeding, gastrointestinal disturbance, and pregnancies. These functions, in turn, helped to identify an optimum dosage (0.125 mg. of norgestimate plus 0.035 mg. of ethinyl estradiol) in the entire range of combinations studied.

Adolescent↗