Clinical Efficacy, Acceptability and Metabolic Effects of New Low Dose Combined Oral Contraceptives

Bergstein, N. A. M.

doi:10.3109/00016347609156449

Cited by 15 publications

(4 citation statements)

References 17 publications

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“…Both oral contraceptives tested in the present trial were equally safe and effective as no pregnancies occurred. With regard to NeovlettaB this safety has been confirmed in a number of previous reports (1,2,4,6,17,18).…”

Section: Discussionsupporting

confidence: 63%

“…Following some years of clinical experience it is now generally accepted that as little as 30 pg of ethinyl estradiol in combination with 150 pg of le-vonorgestrel per day offers a highly acceptable combination although a certain increase in bleeding irregularities, particularly during the first few treatment cycles, occurs with this combination compared with higher dosed preparations (1,2,6,16,18).…”

mentioning

confidence: 99%

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FERTILITY REGULATION USING “TRIPHASIC” ADMINISTRATION OF ETHINYL ESTRADIOL AND LEVONORGESTREL IN COMPARISON WITH THE 30 PLUS 150 μg FIXED DOSE REGIME

Zador¹

1979

Acta Obstet Gynecol Scand

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A new generation of combined oral contraceptive containing staggering amounts of ethinyl estradiol and levonorgestrel (SH B 264 AB) was compared in a randomized multicentre trial with a well established low dose combined pill composed of 30 pg ethinyl estradiol plus 150 pg levonorgestrel (NeovlettaB ) in a total of 489 women over 2,777 cycles. The trial was planned to run for six consecutive months at three clinics in Sweden (296 women) whereas the remaining 193 volunteers were enrolled from clinics in Great Britain and Germany. The case report forms were designed in a fashion to permit evaluation of thk two formulations with regard to their overall reliability and acceptability in terms of cycle control. No pregnancy occurred during the observation period.Out of the total number of patients approximately 90% completed the six months treatmentperiod on both combinations. Bleeding irregularities, such as spotting and/or breakthrough bleeding occurred more frequently on NeovlettaB compared with SH B 264 AB (15.7% versus 10.1% of women) although the total hormone intake is considerably lower using the triphasic formulation. Missed

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Section: Discussionsupporting

confidence: 63%

mentioning

confidence: 99%

FERTILITY REGULATION USING “TRIPHASIC” ADMINISTRATION OF ETHINYL ESTRADIOL AND LEVONORGESTREL IN COMPARISON WITH THE 30 PLUS 150 μg FIXED DOSE REGIME

Zador¹

1979

Acta Obstet Gynecol Scand

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“…The modern formulations have a very low oestrogen content-30 jug-and also a very low progestogen content, which may be advantageous for both mother and child. We do not have enough data about these new compounds, but it was reported recently by Bergstein (1976) that the new low-dosage oral contraceptives may have no adverse effects on the mother, but perhaps some effect on the milk production. But we do not know much about it.…”

Section: Discussionmentioning

confidence: 97%

Side effects of steroid contraception

Gellén

1977

J. Biosoc. Sci.

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SummarySide effects of steroid contraception during lactation are discussed and followed by a review of the relevant literature. It appears that oestrogen has an inhibiting effect on lactation performance, but progestogen alone does not. Most of the undesirable systemic side effects of oral contraceptives on the mother are connected with the relative excess or deficiency of the oestrogen and/or the progestogen component. It is likely that a low oestrogen content preparation causes no dangerous side effects. There are few data about the appearance of contraceptive steroids in breast milk. Probably only a small proportion of the steroids are excreted into the milk. Any adverse effects, on the infant, such as slow weight gain, neonatal breast hypertrophy and breast milk jaundice, are dependent on the two preceding factors. It is doubtful whether the small amount of contraceptive steroids contained in modern pills exert any influence on the fetus. Although further examinations are necessary, the low dosage of progestogen and oestrogen combined contraceptives given at fully established lactation under close control seems to be advantageous to both mothers and their infants.

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“…By some estimates, the potency of ethinyl estradiol is considered to be 1.2 to 1.4 times greater than mestranol [6]. Still others consider the ratio of progestogen to estrogen of the specific compound the critical factor in determining the efficacy and cycle control for low-dose OCs rather than the absolute estrogenic potencies or dosages found in the preparation [7]. Still others consider the ratio of progestogen to estrogen of the specific compound the critical factor in determining the efficacy and cycle control for low-dose OCs rather than the absolute estrogenic potencies or dosages found in the preparation [7].…”

Section: Discussionmentioning

confidence: 99%

A comparative clinical trial of Norinyl 1+35 versus Norinyl 1+50 in Merida, Yucatan, Mexico

et al. 1990

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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.

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Clinical Efficacy, Acceptability and Metabolic Effects of New Low Dose Combined Oral Contraceptives

Cited by 15 publications

References 17 publications

FERTILITY REGULATION USING “TRIPHASIC” ADMINISTRATION OF ETHINYL ESTRADIOL AND LEVONORGESTREL IN COMPARISON WITH THE 30 PLUS 150 μg FIXED DOSE REGIME

FERTILITY REGULATION USING “TRIPHASIC” ADMINISTRATION OF ETHINYL ESTRADIOL AND LEVONORGESTREL IN COMPARISON WITH THE 30 PLUS 150 μg FIXED DOSE REGIME

Side effects of steroid contraception

A comparative clinical trial of Norinyl 1+35 versus Norinyl 1+50 in Merida, Yucatan, Mexico

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