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Comparison of a paper pill with a conventional oral contraceptive tablet.

A multicentre clinical trial comparing a novel formulation (the Paper Pill) of a combined oral contraceptive containing 30 microgram ethinyloestradiol and 150 microgram levonorgestrel with a conventional tablet formulation (Microgynon 30) has been carried out in 336 women over 6 cycles. There were no pill failures in women taking either preparation with one exception in the Microgynon 30 group which was due to poor patient compliance. Cycle control judged by cycle length, duration and amount of withdrawal bleeding and the incidence of intermenstrual bleeding was good in both groups. The number of adverse effects was slightly less in the Paper Pill group and fewer withdrawals for questionnaire reasons were noted than in the Microgynon 30 group. A questionnaire showed that the Paper Pill was accepted well by the majority of women in the trial.

Administration, Oral↗

Clinical tolerance of a combined monophasic contraceptive agent containing a low-dose of ethinyloestradiol and gestodene in adolescents.

The clinical effects and the contraceptive effectiveness of a monophasic preparation containing 30 micrograms ethinyloestradiol and 75 micrograms gestodene per tablet were assessed in a study of 115 healthy adolescents (mean age 18.5 +/- 2 years) covering a total of 712 menstrual cycles (mean of 8 cycles per patient). There was a number of cases of discontinuation of the study (70/115), mainly due to poor discipline in tablet intake in this particular age group. Only 20 cases discontinued the study for medical reasons. No pregnancies occurred, in spite of the fact that tablets were frequently forgotten (11% of cycles). Eighty-eight percent of cycles presented a normal bleeding pattern from the second month of treatment on. Spotting was sporadic (less than 8% from the 2nd cycle) and was mainly associated with tablet omission. Intermenstrual bleeding (breakthrough bleeding) occurred in 19% of the first menstrual cycles but only in 5% of the second and following cycles. Tenderness of the breast was the most frequent subjective complaint (3.4% of cycles), followed by urogenital problems, headaches and digestive disorders. However, all complaints remained sporadic (13.4% of cycles). The systolic blood pressure showed little variation, with only a slight increase from 123 to 125 mmHg after 6 months of treatment. Though not clinically important, an increase in diastolic blood pressure was observed (from 76 to 82 mmHg after 6 months). The patients showed a tendency to increase weight (from 54.4 to 56.7 kg after 6 months.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Multicenter trial of a monophasic oral contraceptive containing ethinyl estradiol and desogestrel.

A clinical trial was conducted at 47 centers in 11 countries to assess the efficacy and acceptability of a monophasic oral contraceptive containing 30 micrograms ethinyl estradiol and 150 micrograms desogestrel. 1,613 women took part for a total of 23,258 cycles. One pregnancy occurred in a cycle where two consecutive tablets had been forgotten. Cycle control was excellent, with reported decreases in the duration and amount of withdrawal bleeding during consecutive treatment cycles and a low incidence of irregular bleeding. Blood pressure was not affected during 2 years of use. The incidence of minor side effects was already low in the first treatment cycle and decreased further in the subsequent cycles. The combination (Marvelon) was shown to be a very reliable and acceptable oral contraceptive.

Adult↗

University students' subjective experiences of oral contraceptive use.

A substantial proportion of women who commence oral contraceptive discontinue usage due to unwanted side-effects. In investigations of side-effects in current users, such women are excluded, and hence such studies will tend to underestimate the prevalence of side-effects. One hundred and forty-five female university students (both former and current users) completed a questionnaire focusing on their experiences of the impact of oral contraceptives upon their psychological and physical well-being. Although, on average, over half the women reported no effect, the vast majority of those who did report a change in well-being deemed this to be negative. The only exception was pelvic pain which was reported to be improved by oral contraceptive use.

Adult↗

Hormonal intrauterine devices.

Intrauterine administration of progestogens from an IUD was introduced more than 15 years ago in order to improve the contraceptive efficacy and to reduce side-effects. A device releasing 20 micrograms levonorgestrel daily (Levonova) with a life span of at least 5 years is now available and has been subjected to an extensive study including 1821 women followed during 5 years. The safety and efficacy were evaluated in comparison to Cu-T IUDs. The pregnancy rate (Pearl index) was 0.09. During the first two cycles after insertion intermenstrual bleeding was common, otherwise the frequency of side-effects was low. The results seem to justify the conclusion that intrauterine administration of progestogens represents a further development of IUDs and hormonal contraception. Furthermore, these devices have proven to be effective in treatment of heavy menstrual blood losses. In many menorrhagic women, use of these IUDs can replace more invasive surgical methods such as hysterectomy or endometrial resection. Intrauterine administration of progestogens is also effective in opposing the proliferative effect of oestrogen on the endometrium in women on hormonal replacement therapy.

Adolescent↗

Long-term experience with a low-dose oral contraceptive.

Oral contraception has proved to be the most efficient reversible method of fertility control for over 25 years. During this period, various investigations and epidemiological studies have suggested that some risks may be involved, but, on the other hand, a number of non-contraceptive benefits have become obvious. The results of these investigations were taken into account when new formulations had to be developed, with an aim to improving hormonal fertility control with regard to its tolerance, cycle control, and impact on metabolism. Since then, the objective of research has been to contrive new hormonal contraceptives which ensure safety to the largest possible extent, from a medical point of view, for the sake of the patient, without affecting contraceptive effectiveness. The aim to reduce side-effects connected with the use of oral contraception, as well as to lower the risks possibly involved, has obviously been achieved by extensive research. Both by devising a new substance and reducing doses, the criteria of modern low-dose oral contraception have been met, as has become evident in the course of the clinical experience gathered with Femovan.

Acne Vulgaris↗