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Query: UMLS:C0027497 (
nausea
)
23,468
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
A comparison of the triphasic
Triphasil
and the combined oral contraceptive Diane 50 for treatment of acne for 6 cycles showed significant improvement in both groups.
Triphasil
(Wyeth-Ayerst) contains 50 mcg levonorgestrel and 30 mcg ethinyl estradiol, 75 mcg levonorgestrel and 40 mcg ethinyl estradiol for 5 days and 125 mcg levonorgestrel and 30 mcg ethinyl estradiol for 10 days. Diane 50 (Schering Ag) contains 2 mg cyproterone acetate and 50 mcg ethinyl estradiol for 21 days per cycle. 10 women in each group had physical, pelvic, ophthalmologic and neurologic exams, hematologic and biochemical screens, assays of free testosterone, sex hormone binding globulin (SHBG), androstenedione, dehydroepiandrosterone SO4 (DHEAS), progesterone, and computations of acne and hirsutism scores. Subjects had used tetracyclines, isotretinoin, erythromycin, topical clindamycin and benzoyl peroxide previously, but were withdrawn from medication in the cycle before the intervention. The mean acne scores, derived from grading and counting lesions and comedones, fell from 63.3 to 6 in the Diane 50 and from 64.2 to 4.5 in the
Triphasil
group. Subjective results were excellent for 6, good for 2 and unsatisfactory for 2 in the Diane 50 group, and excellent for 8 and good for 2 in the
Triphasil
group. In both groups mean free testosterone, androgen index, androstenedione and DHEAS, and an increase in SHBG were documented. 5
Triphasil
and 5 Diane 50 subjects had increased cholesterol levels during the trial, the only abnormality detected. Side effects reported were recurrence of varicose veins and hemorrhoids in 1 women who withdrew, and complaints of mastalgia,
nausea
, dysmenorrhea, migraine, headache, backache and vaginal discharge.
...
PMID:An open study of Triphasil and Diane 50 in the treatment of acne. 183 45
Results are presented of a phase 3 international multicenter trial to study the effect of a new, low-dose oral contraceptive (OC) containing 20 mcg ethinyl estradiol and 150 mcg desogestrel (
Mercilon
) with regard to efficacy, cycle control, blood pressure, and acceptability. In total, 1684 women from 12 European countries were included in the study. 4 pregnancies occurred, 3 of them patient failure and 1 tablet failure. The overall Pearl Index was 0.20. The frequency of irregular bleeding was comparable to that recorded with other commonly used low-dose OCs. No serious side effects occurred. The incidence of the most frequently reported subjective side effects, i.e., headache,
nausea
, and breast tenderness, was already low after the 1st cycle of treatment and decreased to below pretreatment levels with continued use. There was a small increase in mean body weight, which was confined essentially to young women. The preparation did not affect the mean systolic or diastolic blood pressure. This new preparation has thus far proven to be an effective, safe, and well-accepted ultra low-dose OC.
...
PMID:Phase III clinical trial with a new oral contraceptive containing 150 micrograms desogestrel and 20 micrograms ethinylestradiol. 183 99
The performance of a low-dose triphasic oral contraceptive (OC) in the first four cycles of use was evaluated by 1,326 primary-care physicians and specialists across Canada in a phase-IV postmarketing trial. Data were available from 5,460 women who completed 19,756 cycles of use with
Synphasic
. The incidence of intermenstrual bleeding characteristically decreased over the four cycles to 10% in women who were first-time users of OCs, to 14% in women who had previously used OCs but had discontinued use until this trial, and to 16% in women who had switched from another OC to
Synphasic
. The women reported a low incidence of headache,
nausea
, weight gain, breast complaints, and acne while receiving
Synphasic
. The results demonstrate good endometrial control with
Synphasic
and a high level of patient acceptance.
...
PMID:Synphasic tablets in Canadian practice: a phase-IV multicenter study. 186 41
Health practitioners use many methods and agents to bring on cervical ripening in early pregnancy, such as intracervical tents and pharmacological techniques, to induce a therapeutic abortion. Prostaglandins alter myometrial and cervical tissue and are the most often used pharmacological technique. Reduced collagen concentration, an increase in water volume, an increase in prostaglandins (PGE2, PGI2, and PGF2 alpha), and a change in the glycosaminoglycan (GAG) content coincide with cervical ripening, yet the mechanism responsible for these changes is obscure. Prostaglandins appear to cause the breakdown of collagen or change the GAG/proteoglycan content. Research shows that prostaglandins can initiate cervical ripening at any stage of pregnancy.
Estradiol
stimulates prostaglandin production thereby al so inducing cervical dilation. Relaxin also demonstrates an ability to ripen the cervix. In addition, mifepristone (RU-486) is gaining acceptance as a cervical ripening agent. In fact, RU-486 and gemeprost have at least 95% success rate compared to 92% for gemeprost alone or 85% with RU-486 alone. The only effective and acceptable prostaglandins to use at gestation of 0-8 weeks are sulprostone, gemeprost, and 9-methylene-PGE2. At t his gestational age, pharmacological modulation is all that is needed. Even though they are effective (abortion rate 90%), side effects are expected to occur (pain,
nausea
, and vomiting). Similarly, prostaglandin analogues are preferable for cervical ripening in women at 8-12 weeks gestation. Suction curettage or other surgical techniques then are used to remove the conceptus. At 12-16 weeks gestation, many physicians prefer the same protocol as that of 8-12 weeks gestation. Other choose to infuse PGE2 and saline into the amniotic fluid to stimulate uterine contractions. Another procedure at 12-16 weeks involves 1mg vaginal pessaries of gemeprost every 3 hours to ripen the cervix and stimulate contractions. After 16 weeks, the methods for 12-16 weeks still apply.
...
PMID:Pharmacological modulation of cervical compliance in the first and second trimesters of pregnancy. 187 72
In view of the considerable debate concerning the possible failure of contraception in women taking broad spectrum antibiotics, the authors examined a group of 12 women ages 22-32 in a controlled study. Each had been on longterm therapy with oral contraceptives (OCs) containing ethinyl estradiol (EE) and levonorgestrel (Ng) for at least 6 months and all were in good general health. Blood samples were taken about 11.0 hours after dosing with OCs on days 5, 6, 7, and 8 of their contraceptive cycle, for measurement of
EE2
, Ng, FSH, and LH by radioimmunoassay. In addition, blood samples were taken on days 19, 20, and 21 of their contraceptive cycle for assay of progesterone concentrations in plasma. The study was repeated in the next cycle of OC use during which the patients took temafloxacin, a broad spectrum quinoline antibiotic in a dose of 600 mg twice daily for 7 days, beginning on day 1 of the cycle. All women completed the study satisfactorily as judged by diary cards, tablet counts, and plasma temafloxacin concentrations. In the early part of the study, some
nausea
and headaches were experienced; this was due to the taking of the drug on an empty stomach. When the antibiotic was administered with food, this problem was no longer a concern. There was no evidence of any interaction between temafloxacin and OCs. The plasma concentration of
EE2
was 61.4 +or- 21.2 pg/ml in the control cycle and 68.5 +or- 26.6 pg/ml in the temafloxacin cycle. The plasma progesterone concentration was 0.53 +or- 0.1 ng/ml in the control cycle and 0.6 +or- 0.24 ng/ml in the temafloxacin cycle (p0.01). No woman demonstrated any significant rise in plasma FSH or LH concentrations during temafloxacin therapy. The authors conclude that there is no evidence for a systematic interaction between temafloxacin and OCs and that there is no need for use of alternative contraceptive methods in women taking OCs who are also being treated with temafloxacin.
...
PMID:The lack of interaction between temafloxacin and combined oral contraceptive steroids. 190 91
From August 1988-June 1989, 983 physicians participated in a phase IV trial by following 7759 women using the monophasic oral contraceptive (OC),
Demulen
1/35 (1 mg ethynodiol diacetate and 35 ug ethinyl estradiol) to evaluate its efficacy and safety. The total number of cycles for the study stood at 21,440. In addition, the total woman-years stood at 1787. Only 6382 patients could be evaluated for safety. 4.4% of the patients had adverse reactions to the OC, but only 1.7% of all patients stopped taking it. The leading side effects included
nausea
(67 cases), headache (45), amenorrhea (42), emotional changes (30), breast pain (19), dysmenorrhea (12), and 11 cases of weight gain, abdominal/pelvic pain, and bloating. Of the 280 reported adverse reactions, only 87 (31%) were considered severe. The leading serious adverse reactions were depression (10) and hypertension (6). Only 5412 patients could be used to determine efficacy. The physicians initially reported 121 (2.2%) pregnancies during the study. The researchers learned that 33 of the 84 returned 2nd questionnaires (response rate, 70%) reported that the women conceived after enrollment but before taking the OC. 36 conceived while taking it, but 8 did not take it daily. Noncompliance may have contributed to pregnancy for the remaining 28 cases. Therefore the 36 confirmed pregnancies made for a failure rate of .7%. 85.7% of the pregnancies happened in the 1st 3 months of taking the OC. Either patient noncompliance or true medication failure accounted for treatment failure. Therefore it is important for physicians to instruct patients on how to take OCs correctly.
...
PMID:Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial. 204 81
Thirty-one postmenopausal women with advanced breast cancer have been treated with the nonsteroidal competitive aromatase inhibitor CGS 16949A at p.o. doses of 0.3, 1, and 2 mg twice a day. All patients were assessed for response. Five patients, all treated with 1 mg twice daily, had objective evidence of response (two complete responses and three partial responses); disease stabilized in 17 patients. Minor side effects were reported by ten patients. Two further patients treated with 2 mg twice a day experienced persistent
nausea
which improved after dose reduction, and one patient, treated with 0.3 mg twice daily, developed a vasculitic rash requiring discontinuation of CGS 16949A.
Estradiol
levels measured in 24 patients were significantly suppressed 2 wk after starting CGS 16949A treatment at all doses used. Treatment with 2 mg twice a day lowered estradiol levels to a mean of 29% of pretreatment values which was significantly lower than the corresponding figure of 57% for patients treated with 0.3 mg twice daily. Aldosterone levels were significantly lowered below pretreatment values by the 1- and 2-mg twice daily doses. No clinically apparent cases of adrenocortical insufficiency occurred, although small changes in serum electrolyte levels were noted. The results indicate that CGS 16949A is an effective aromatase inhibitor, requiring further evaluation in the treatment of advanced breast cancer. The optimal dose is likely to be 1 mg twice a day.
...
PMID:Preliminary study of the treatment of advanced breast cancer in postmenopausal women with the aromatase inhibitor CGS 16949A. 213 67
A comparative clinical trial of two combined oral contraceptives differing only in estrogen type and dosage was conducted at the Centro de Investigaciones Hideyo Noguchi in Merida, Yucatan, Mexico. The trial was designed to determine the differences between
Norinyl
1 + 50 (Syntex) and
Norinyl
1 + 35 (Syntex) in rates of discontinuation and frequency of selected side-effects which might contribute to method discontinuation. Three hundred women were randomly assigned to either the
Norinyl
1 + 35 group or to the
Norinyl
1 + 50 group and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. In the
Norinyl
1 + 35 group, more women experienced an increase in intermenstrual bleeding (primarily staining and spotting) (p less than 0.05), breast discomfort (p less than 0.05) and
nausea
than in the
Norinyl
1 + 50 group. There was a significantly higher discontinuation rate for personal reasons, such as desired change of method and method not needed, among the women taking
Norinyl
1 + 35 (p less than 0.05). The largest number of discontinuations comprised women discontinuing for menstrual problems in both groups. The life-table total discontinuation rate at 12 months was 52.0 for the
Norinyl
1 + 35 group and 50.7 for the
Norinyl
1 + 50 group. The lost-to-follow-up rates at 12 months were 17.8 for the
Norinyl
1 + 35 group and 22.8 for the
Norinyl
1 + 50 group.
...
PMID:A comparative clinical trial of Norinyl 1 + 35 versus Norinyl 1 + 50 in Merida, Yucatan, Mexico. 220 18
Japan began oral contraceptive (OC) clinical studies after 1987 when the government requested studies of 2400 menstrual cycles and a minimum of 100 patients for 12 cycles and 20-30 patients for 24 cycles. 3 monophasic, 1 biphasic, and 4 triphasic drugs were tested from 6 companies and all contained ethinyl estradiol with different progestins (norethindrone, levonorgestrel, or desogestrel). In phase I, the purpose was to examine the pharmacological effects and shortterm safety of all 8 drugs among a small number of healthy volunteers and a comparison of results with Western women. Phase II was eliminated. Phase III involved examination of toleration of the drug, dropout rate, effects on cycle control such as bleeding patterns, metabolism, and effects on hormone secretion. In phase I,
Ortho
Novum 7/7/7 was administered at 3 dose levels for 1 menstrual cycle and the results were toleration and minimal side effects. Some experienced bleeding, spotting, and breakthrough bleeding. Suppression of ovulation was successful. In phase III, 40 medical schools, 174 hospitals, and 200 investigators enrolled 648 patients of which 117 withdrew. Interim results among women 22-42 years show no adverse effects either in self- reports or laboratory tests. There were nuisance side effects such as
nausea
, weight gain, and headache, and some amenorrhea and bleeding during different cycles. There is a high continuation rate and patient satisfaction. Results from the full sample are still pending.
...
PMID:The current status of oral contraceptive clinical development in Japan. 257 51
A brief review on how the combined oral contraceptive
Ovral
is used, without official US FDA approval, as a postcoital contraceptive is presented. The pill contains 50 mcg ethinyl estradiol and 0.5 mg norgestrel. Presumably the estrogen prevents implantation. The recommended dosage is 2 tablets taken 12 hours apart, preferably within 12-24 hours, and no later that 72 hours, after intercourse. Compared to a likelihood of pregnancy, in the event of unprotected intercourse, of 20% 3 days before ovulation, 25% 1 day before ovulation, and 15% on the day of ovulation,
Ovral
has been reported to prevent all by 1.8% of pregnancies. The highest failure rate cited was 7.4%. The only adverse effects noted were
nausea
, vomiting and breast tenderness. No fetal malformations have been published with this regimen.
...
PMID:Ovral as a "morning-after" contraceptive. 279 42
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