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An open assessment of a new low dose oestrogen combined oral contraceptive.

This was a multicentre general practitioner study using a new low dose oral contraceptive, Ovamin 30 (ethinyloestradiol 30 microgram, ethynodiol diacetate 2 mg). Results showed a pregnancy rate calculated as a Pearl Index of 0.4. An analysis of bleeding patterns showed consistently acceptable cycle control. From these results it would appear that Ovamin 30 is an effective and well tolerated low dose oral contraceptive preparation.

Contraceptives, Oral

Availability of norethisterone acetate from combined oral contraceptive tablets.

The availability of norethisterone acetate in HCl (0.1 mol/l) from combined oral contraceptive tablets in the presence of certain proprietary preparations and adsorbent drugs which are used as antacids, intestinal adsorbents and for peptic ulcer was investigated. The percent dissolution of the hormone in the presence of these drugs was greatly reduced depending mainly on the nature of the adsorbent drugs.

Adult

Preliminary results from a swedish multicenter trial of a new low dose combined oral contraceptive.

Neovletta, a new combined low estrogen -- low progestogen oral contraceptive was investigated in 226 women over 1921 cycles at three different clinics. This report constitutes a preliminary evaluation of a large scale multicenter study being conducted in Sweden. No pregnancy was reported during the observation period. The length of menstrual cycle was generally 28 days and withdrawal bleeding during the tablet free period was missed in only 0.9 per cent of the cycles. The duration of menstruation was shortened by about one day. The amount of menstrual flow, as registered by the women, showed a reduction during treatment. Spotting and breakthrough bleeding were increased during the first three treatment cycles, whereas from the fourth to 12th cycles the incidence of these bleeding irregularities was not much different from pretreatment values. A total of 46 women (20 per cent) discontinued treatment due to side-effects of which bleeding irregularities constituted the major problem.

Adult

Comparative studies on two combination oral contraceptives, one containing synthetic estrogen, the other "natural" estrogens.

Two combined oral contraceptives, one containing ethinyl estradiol and the other micronized estradiol and estriol, were compared by measuring a variety of endocrine and renal parameters over nine months. Significant changes were observed in plasma renin activity (P.R.A.) on the synthetic estrogen. Much larger changes were observed in the total urinary estrogens on patients taking the "natural" estrogens reflecting the amount of estrogens required to be excreted in the urine.

Adult

Serum levels of FSH, LH, estradiol-17 beta and progesterone following the administration of a combined oral contraceptive containing 20 micrograms ethinylestradiol.

An oral contraceptive containing 20 micrograms of ethinylestradiol and 250 micrograms of levonorgestrel was given to 5 normally menstruating women for two consecutive cycles. Peripheral serum levels of FSH, LH, estradiol-17 beta and progesterone were determined during the treatment period and during two control cycles, one immediately before, and one immediately after treatment. In all 5 women studied there were no LH peaks and no luteal phase levels of progesterone during the treatment cycles indicating complete inhibition of ovulation. 4 of the 5 women showed no biphasic estradiol pattern. Posttreatment control cycles showed reestablished ovulatory pattern in 4 of the 5 subjects.

Adolescent

Failure of withdrawal bleeding during combined oral contraceptive therapy: "amenorrhoea on the pill".

Serum follicle stimulating hormone, luteinising hormone and oestradiol-17beta concentrations have been measured in 21 patients with failure of withdrawal bleeding during combined oral contraceptive therapy and 21 matched controls with a normal bleeding pattern. Gonadotrophin and oestradiol-17beta concentrations were effectively suppressed in all patients during the phase of contraceptive ingestion. During the week between courses of treatment, there was a significant rise in the gonadotrophin (p less than 0.02) and oestradiol (p less than 0.05) concentrations in the patients but not in the controls. It is suggested that patients with failure of withdrawal bleeding during combined oral contraceptive therapy may have higher total oestrogen levels during the treatment-free week because of a less persistent suppression of hypothalamic-pituitary-ovarian function.

Amenorrhea

Serum level and 24hr. excretion pattern of potassium following the intake of combined oral contraceptives.

Serum level and 24hr urinary excretion pattern of potassium have been studied in 104 healthy women, aged 18-44 years, using combined oral contraceptives for a period of 3-48 months, and results have been compared with those obtained from 21 healthy controls of the same clinic, aged 19-40 years, using IUD. There was no significant change observed in serum potassium level, but 24hr urinary excretion pattern of potassium decreased significantly in 90% of the individuals equivalent to 2.6-78.3% of the mean control, possibly due to a retention of potassium in the cells.

Adolescent

Ovulation inhibition with a combined oral contraceptive containing 20 micrograms ethinyl estradiol and 250 micrograms levonorgestrel. Serum levels of the active ingredients and FSH, LH, estradiol 17-beta and progesterone.

In order to investigate the possible ovulation inhibitory effect of a new oral contraceptive containing a combination of 20 micrograms ethinyl estradiol and 250 micrograms levonorgestrel peripheral serum from five healthy women between 17 and 24 years were analysed for FSH, LH, estradiol 17-beta and progesterone. The measurements were carried out during a control cycle before the treatment, during two treatment cycles and during a subsequent control cycle. In addition, serum levels of ethinyl estradiol and norgestrel were determined during the treatment periods. Radioimmunological methods were utilized for all the measurements. In all five women studied there was a complete inhibition of ovulation during treatment as indicated by a lack of mid-cycle LH peaks and by suppression of normal luteal phase levels of progesterone. Four out of the five women showed no biphasic estradiol pattern. During treatment the serum levels of levonorgestrel varied between 1 and 10 nmol/l while the levels of ethinyl estradiol usually were below the limit of detection for the method used (below 85 pmol/l). Post-treatment control cycles revealed a re-establishment of the ovulatory pattern in four of the five subjects.

Adolescent

[Clinical trial of a combined oral contraceptive with low estrogen dose (author's transl)].

309 women took a combined oral contraceptive (0.04 mg ethinylestradiol and 2.0 mg lynestrol) in 1876 cycles under clinical supervision. The preparation was extremely well tolerated. Pregnancy did not occur; In 57 cases the administration of the tablets was concluded prematurely, but side effects were given as the reason for this discontinuation of the contraceptive in only 6.5% of the cases. Withdrawal bleeding lasted 3.9 days in the control cycle and 3.7 days in the 6th treatment cycle. Breakthrough bleeding occurred in 0.3% of the women.

Adult

A randomized double-blind trial of two low dose combined oral contraceptives.

Fifty-five women using Loestrin-20 (20 microgram ethinyl oestradiol and 1 mg norethisterone acetate) as an oral contraceptive have been compared with a like number using Microgynon-30 (30 microgram ethinyl oestradiol and 150 microgram levonorgestrel) in a randomized, double-blind trial. Despite the small sample size, the main finding in the trial is clear-cut; Loestrin-20 provides poor cycle control and is thus less acceptable as an oral contraceptive than Microgynon-30. Although there is also a suggestion that Loestrin-20 may be less effective than Microgynon-30, the difference in the accidental pregnancy rates is not statistically significant.

Adolescent

Effect of varying amounts of ethinyl oestradiol in the combined oral contraceptive on plasma sex hormone binding globulin capacity in normal women.

The plasma sex hormone binding globulin (SHBG) capacity has been measured in 52 normal women, 11 women on various oral contraceptives containing 50 micrograms of ethinyl oestradiol and 11 women on oral contraceptives containing less than 35 micrograms of ethinyl oestradiol. The results show that women on oral contraceptives containing 50 micrograms of ethinyl oestradiol have a significantly raised SHBG capacity (p less than 0.005) whereas those patients on oral contraceptives containing 35 micrograms or less of ethinyl oestradiol have SHBG capacities which do not differ significantly from normal ovulating women (p greater than 0.05). Thus the 35 micrograms pill interferes less with bound/unbound sex steroid ratios than does the 50 micrograms pill.

Contraceptives, Oral

Increased aldosterone plasma protein binding in women on combined oral contraceptives throughout the menstrual cycle.

Plasma aldosterone concentration and the percentage of the fraction bound to a specific plasma aldosterone-binding globulin (ABG) were measured throughout the menstrual cycle in 26 healthy women aged between 19 and 38 yr who were receiving estrogen-containing oral contraceptives (OC), Midafternoon upright levels of total plasma aldosterone were similar in control and OC subjects and showed normal cyclic fluctuation in both groups. The percentage of ABG-bound aldosterone was markedly higher in OC subjects than in controls at all stages of the cycle and showed a positive correlation with the mean blood pressure when all OC subjects studied were considered. In addition, when the plasma ABG levels were measured 6 months or more after the start of medication, they appeared to be related to the dose of estrogen in the OC, but not to the length of time of its administration. The identity of plasma ABG in OC subjects with that in control subjects was also established.

Adult