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Biomedical subjects

S A Pasquale

Publications and source records attributed to S A Pasquale.

16 recordsLinked to original sources
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↗
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↗
PubMed1979

A dose-response study with Monistat cream.

A randomized multiregimen clinical study was undertaken using Monistat Cream for the treatment of vulvovaginal candidiasis. The objective of the study was to find if there is a shorter regimen comparable in effectiveness to the currently marketed 14-day regimen. The results indicate that there is no significant difference between the cure rate obtained for 7 days of therapy and for 14 days of therapy.

Candidiasis, Vulvovaginal↗
PubMed1978

Clinical experience with a low dose oral contraceptive containing norethisterone and ethinyl oestradiol.

The results are presented of a clinical investigation of an oral contraceptive containing 0.5 mg norethisterone and 0.035 mg ethinyl oestradiol. The medication was administered orally as a 21-day cyclic regimen in 1,168 women. Duration of use was from 1 to 53 cycles with an overall total of 16,345 cycles. When the preparation was taken as directed, no pregnancies occurred. Three women conceived during the course of this study; however, these subjects missed 3, 2, and 1 prescribed tablets, respectively, and their pregnancies are thus judged due to patient failure. The overall pregnancy rate was 0.22 per 100 women years of use calculated as a Pearl Index. Intermenstrual bleeding (spotting and/or breakthrough bleeding) was noted primarily in the early cycles, soon tapering off to a lower and stable level. The overall cumulative cyclic incidence of amenorrhoea was 1.0%.

Adolescent↗
PubMed1977

Evaluation of Monistat cream (miconazole nitrate 2%) in a reduced regimen for the treatment of vulvovaginal candidiasis.

A carefully conducted study with reduced regimens of Monistat cream (miconazole nitrate 2%) was undertaken to compare the therapeutic cure rates in patients with vulvovaginal candidiasis on Monistat cream for 7, 10 and 14 days. Five clinical investigators participated in the study and randomly assigned 139 patients, who met criteria outlined in the protocol, to either the 7-, 10, or 14-day regimen. Case records of 108 patients were used in evaluating the results. Thirty-one records were classified as invalid and were eliminated from the final analysis. Analysis of the data revealed no statistically significant difference in cure rates between the three regimens. It can be concluded, therefore, that Monistat cream used in a regimen consisting of 7 or 10 days of therapy has a cure rate equivalent to the currently recommended 14-day regimen.

Candidiasis, Vulvovaginal↗
PubMed1977

Treatment of vulvovaginal candidiasis in pregnancy. A comparative study.

A carefully controlled comparative study showed miconazole nitrate 2% vaginal cream (Monistat) to be a highly effective agent in the treatment of vaginal candidiasis in pregnant subjects. Miconazole nitrate was significantly more effective than nystatin (Mycostatin) in the treatment of vaginal candidiasis in all three trimesters of pregnancy, and also more effective regardless of whether the candidal infection was primary or recurrent. Observations relating to the safety of this therapy during pregnancy were made and discussed.

Acute Disease↗
PubMed1976

Developing optimum drug regimens.

In clinical pharmacological trials the determination of the optimum regimen for a drug using the technique of response surface analysis is proposed as being more advantageous than traditional analyses of dose response relationships. Major considerations in favour of this technique are that the optimum regimem can be identified with a minimum of human experimentation, and unacceptable regimens are eliminated from the study early, at a substantial saving of time and money.

Drug Administration Schedule↗