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At least 127 records · Page 7Linked to original sources
PubMed1982

The effect of oral contraceptives on antiaggregatory prostacyclin and proaggregatory thromboxane A2 in humans.

The effect of different types of oral contraceptives on the productions of antiaggregatory prostacyclin (PGI2) and proaggregatory thromboxane A2 (TxA2) was studied by measuring the stable metabolites of these prostanoids, that is, 6-ketoprostaglandin F1 alpha (6-keto-PGF1 alpha) and thromboxane B2 (TxB2), respectively, from plasma. In addition, the capacity of the platelets to produce TxB2 during spontaneous clotting was studied by measuring the TxB2 levels from the serum incubated at +37 degrees C for 60 minutes. The material consisted of 48 women who had used estrogen-containing oral contraceptives for 2.0 +/- 1.9 years (mean +/- SD), 24 women using progestogen-only pills for 3.7 +/- 2.0 years, and 42 women of the same age using no oral contraceptives or intrauterine contraceptive device. The plasma concentrations of 6-keto-PGF1 alpha in women with combined oral contraceptives (65.5 +/- 16.1 pg/ml, mean +/- SD) was lower (p less than 0.01) than that in the control subjects (77.4 +/- 26.4 pg/ml), whereas the use of combined oral contraceptives was associated with no changes in TxB2 levels in plasma or serum, in women with progestogen-only oral contraceptives, the plasma levels of 6-keto-PGF1 alpha and TxB2 were normal, but the capacity of the platelets to release TxB2 during spontaneous clotting was decreased (113.6 +/- 77.6 ng/ml versus 179.9 +/- 81.9 ng/ml, p less than 0.05). In a prospective trial on 11 women, who started using 30 microgram of ethinyl estradiol and 150 microgram of levonorgestrel, no changes in PGI2 or TxA2 were seen during the first 3 months of usage. The decrease in antiaggregatory PGI2 during the prolonged use of estrogen-containing oral contraceptives may be associated with the increased risk of thromboembolism.

6-Ketoprostaglandin F1 alpha↗
PubMed1984

Discontinued use of intrauterine contraceptive device and pregnancy loss.

To evaluate the risk of spontaneous abortion among former intrauterine contraceptive device (IUD) users, we compared the contraceptive history of 328 women with a spontaneous abortion up to 28 weeks' gestation with that of 1715 women having a term delivery. A similar percentage of case and comparison subjects reported prior IUD use as well as IUD use within the year before pregnancy. However, IUD use lasting more than 12 months was associated with a 1.5-fold increase in the crude risk of spontaneous abortion up to 28 weeks' gestation (p less than 0.05), a 1.8-fold increased risk of first-trimester spontaneous abortion, and a 1.7-fold increased risk of incomplete abortion (p less than 0.01). The results were not altered by control of individual confounding factors. When confounding factors were controlled simultaneously in a multiple logistic regression analysis, the relative risks were 1.4, 1.7 and 1.6, respectively; however, they were no longer statistically significant. The results suggest that prolonged IUD use may be associated with a modest increase in risk of subsequent spontaneous abortion.

Abortion, Incomplete↗
PubMed1984

Oral contraceptives and benign breast disease: a case-control study.

The relationship between benign breast disease and use of oral contraceptives was analyzed in a case-control study conducted in Milan with 288 cases of clinically relevant and histologically confirmed benign breast disease and 285 age-matched controls with a spectrum of acute conditions apparently unrelated to use of oral contraceptives. Compared to the risk for women who had never used oral contraceptives, the relative risk for users was 1.0 (95% confidence interval: 0.6 to 1.5). There was no significant association with duration of use; however, a significantly lower relative risk was found in women using oral contraceptives during the year before breast biopsy (relative risk: 0.4; 95% confidence interval: 0.2 to 0.8). The protection in current users increased with increasing duration of use. In spite of this finding, the overall results of the present study do not support the hypothesis that oral contraceptive use protects against development of histologically confirmed and clinically relevant benign breast disease.

Adolescent↗
PubMed1992

Contraceptive compliance with a levonorgestrel triphasic and a norethindrone monophasic oral contraceptive in adolescent patients.

OBJECTIVE: This study was undertaken to assess the impact of two low-dose oral contraceptive pills on compliance and side effects in adolescent patients. STUDY DESIGN: The use of a levonorgestrel-containing triphasic pill (N = 114) was compared with that of a monophasic (1 + 35) norethindrone-containing pill (N = 110) at two different sociodemographic sites. RESULTS: No significant difference in compliance or pill satisfaction was observed between the pills. Socioeconomic factors were the overriding predictors of compliance. At 3 and 12 months of follow-up, there were significantly fewer complaints of overall side effects (p less than 0.001 and p = 0.004, respectively), breakthrough bleeding (p = 0.017 and p = 0.018), and pill amenorrhea (p = 0.002 and p less than 0.001) among users of the triphasic pill. Mean weight change at 12 months was +1.1 kg for the monophasic pill and -0.1 kg for the triphasic pill. All known pregnancies occurred among noncompliant city clinic patients. CONCLUSIONS: Adolescents experienced fewer side effects with the triphasic pill than with the monophasic one, but compliance was the same.

Adolescent↗
PubMed1979

Long-term multicentre trial with TA-RO CAP, a new spermicidal product.

326 healthy couples were selected to enter the trial of a new intravaginal contraceptive called the TA-RO CAP. The trial lasted three years. Clinical and laboratory examinations were performed periodically to determine the long-term effectiveness, tolerability and acceptance. Statistical evaluation of results was performed by life-table analysis.

Actuarial Analysis↗
PubMed1980

A randomized, double-blind study of two combined oral contraceptives containing the same progestogen, but different estrogens. World Health Organization Task Force on Oral Contraception.

The results are reported of a randomized, double-blind study of two daily oral contraceptives, both containing 3mg norethisterone acetate; one also contained 50 microgram ethinyl estradiol, while the other contained a mixture of micronized 4mg estradiol plus 2mg estriol. The trial was conducted to a common protocol at WHO Collaborating Centres for Clinical Research (CCCR's) in Bangkok, Bombay, Singapore and Szeged. Of the 925 women who entered the study, 458 received the product containing "natural" estrogens and 467 received the product containing ethinyl estradiol. Analysis of admission characteristics showed that the two groups were very closely matched. There was no statistically significant difference in contraceptive efficacy between the two products; both have annual failure rates of approximately 1 per 100 women. The discontinuation rate after one year was 51.5 for the "natural" estrogen product and 48.4 for the one containing synthetic estrogen. Discontinuation for menstrual irregularities was significantly higher for the "natural" estrogen preparation. During both the first three treatment cycles and the tenth to twelfth cycles, the incidence of various menstrual irregularities was significantly higher in the "natural" estrogen contraceptive. Adverse clinical associations were those commonly reported with other combined oral contraceptives for both preparations. It is concluded that the high incidence of menstrual irregularities associated with the particular combination of norethisterone acetate and "natural" estrogens renders it less suitable for general use in family planning programmes than combinations containing synthetic estrogens, such as ethinyl estradiol.

Adolescent↗
PubMed1981

Plasma levels of ethinylestradiol (EE) during cyclic treatment with combined oral contraceptives.

The purpose of the present study was to extend the still limited data concerning ethinylestradiol (EE) plasma levels after repeated daily ingestion of a combination pill during the course of classical cyclic treatment. Plasma EE levels were followed in 13 volunteers throughout, in total, 19 treatment cycles with either a 50 ug EE (+ 125ug d-norgestrel) or a 30 ug (+ 150ug d-norgestrel) containing oral contraceptive. In addition, single plasma EE determinations were performed in 110 chronic oral contraceptive users. Whereas different patterns in plasma EE levels (sampling 24 hours following last pill ingestion) were observed among the different volunteers, the mean levels increased progressively during treatment and reflected closely the differences in dosage. The values obtained in the volunteers at the end of the treatment cycle showed important interindividual variations. The findings during a first treatment cycle or during the following ones were similar and for different treatment cycles in the same patient, the patterns in plasma EE levels were consistent. The results for single plasma determinations in chronic contraceptive users (sampling between 8th and 21st day of treatment cycle, 9 to 24 hours since last pill ingestion) showed more pronounced interindividual variations, the individual EE levels being not correlated to parameters such as body weight, body surface, months of oral contraception prior to the study, sex hormone binding capacity or day of the cycle. However, significant differences in mean plasma EE levels were noticed for patients treated with different commercial preparations with identical EE content, suggesting the existence of differences in bioavailability. The relevancy of plasma EE determinations is discussed and from the results of the present study, it is concluded that a strictly standardized time of sampling is an absolute condition for obtaining interpretable results.

Contraceptives, Oral↗
PubMed1981

Phase I clinical trial of two contraceptive preparations. Norethisterone enanthate (NEN) and norethisterone acetate (NET).

A Phase I Clinical Trial was conducted in 20 fertile Cuban women using for contraception: Norethisterone Enanthate injectable (NEN) and Norethisterone Acetate minipill (NET). Women had daily blood sampling during a control cycle and during the second month of treatment with either drug. Discontinuation rate was very low (1/20). The preovulatory LH and FSH peaks were abolished in all treated women, basal levels remaining unchanged. The incidence of menstrual disorders as amenorrhea, spotting and inter-menstrual bleeding was greater in subjects using NEN than in those on NET. No pregnancy was reported. Blood pressure was unaltered. Renal, hepatic and thyroid function were unchanged. Cholesterol levels were unchanged and triglycerides significantly decreased with both preparations. Women on either NEN or NET underwent OGTT before and after 2 months treatment. In NEN group glycemia was unchanged but insulin levels increased significantly at 120 minutes. In NET group glycemia and insulin levels were significantly increased at all times during post-treatment OGTT. Both forms of Norethisterone were well accepted by this group of women despite menstrual irregularities. Significant changes were found in the group using NET with regard to carbohydrate metabolism.

Blood Glucose↗
PubMed1982

The progestogen-only mini-pill.

A review is presented of the existing literature on the progestogen-only "mini-pill", a greatly under-used method of contraception. The under-use appears to stem from a lack of awareness on the part of medical advisers of the reasonable efficacy and minor side effects of the method. The benefits and disadvantages have been carefully evaluated and recommendations made for the more widespread use of progestogen-only mini-pills.

Abnormalities, Drug-Induced↗
PubMed1983

The acceptability of a progestagen-only contraceptive during breast-feeding.

The acceptability of an oral contraceptive containing norethisterone 0.35 mg was investigated in a group of mothers followed-up at 6 months post-partum. Eighty-four mothers out of a total of 203 (41%) had used this preparation while breast-feeding and 37 (44%) of these were still taking it at the time of follow-up. The most frequent reason for discontinuation was cessation of breast-feeding. The overall duration of breast-feeding did not appear to differ between this group and a group using occlusive methods of contraception. Uterine bleeding during therapy was related to duration of breast-feeding, with 68% of women who breast-fed for longer than five months remaining amenorrhoeic. Irregular bleeding occurred in 12% of the women who breast-fed for longer than 5 months compared with 43% of those who stopped breast-feeding within the first 3 months. In only 9% of cases was the pill discontinued because of side effects, including irregular bleeding.

Administration, Oral↗
PubMed1985

Phase IV study of the injection Norigest in Pakistan.

A field study of the injectable contraceptive, norethisterone enanthate (NET-EN), was conducted in family planning clinics in Sind and Punjab provinces of Pakistan, to determine the acceptability and feasibility of providing NET-EN in government family planning clinics staffed by Family Welfare Visitors (FWVs). A total of 2147 women were recruited to the study, of whom approximately three-fourths had never previously used contraception. The overall discontinuation rate at one year was 78 per 100 women; the most common reason for discontinuation was bleeding disturbances, including amenorrhea, although returning to the clinic too late for an injection also accounted for a substantial proportion of the discontinuations. Given adequate training, FWVs were shown to be capable of providing NET-EN in family planning clinics, including managing the bleeding disturbances common with this method of contraception. No pregnancies were reported, demonstrating that the method is highly effective when used in a usual family planning clinic situation.

Adolescent↗
PubMed1986

Do insertion-related problems affect subsequent IUD performance?

This investigation compares the IUD performance of 372 women who had an insertion-related problem (most with moderate or severe pain) and 372 matched women who had no such problem; all women had interval insertion. A woman in the Problem Cohort and her matched counterpart in the Comparison Cohort were inserted with the same IUD type by the same insertor on the same day or on close dates. The six IUD types used by these women were Lippes Loop D, Copper-7, Copper T-200, Copper T-380 Ag, Multiload Copper 250 and Multiload Copper 375. Cumulative gross life-table rates of the pertinent events (accidental pregnancy, expulsion and medical removal for bleeding and pain), adjusted for age and parity, were calculated. Between the Problem Cohort and the Comparison Cohort, no differences were detected in the event rates that were of either statistical or practical significance. Results from this preliminary study suggest that the insertion-related problems usually encountered during interval insertion such as insertion pain, syncope and/or mild cervical laceration are not associated with an increased risk of IUD discontinuation due to pertinent events.

Adult↗
PubMed1987

Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial.

This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.

Adolescent↗
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↗