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PubMed1989

Evaluating triphasic oral contraceptives: the rationale for a randomized trial.

The randomized clinical trial is one of the major achievements of our times. Randomized trials set the standard for scientific rigor. They are medicine's closest approximation to the controlled experiments of the laboratory scientist. These studies prevent selection bias and minimize ascertainment bias. In addition, they are statistically efficient. There have been few randomized clinical trials comparing the metabolic effects and adverse drug experiences of low-dose oral contraceptives. Previous studies conducted with oral contraceptives containing higher doses of estrogen (equivalent to greater than 50 micrograms of ethinyl estradiol) may not be relevant today when low-dose preparations are more widely used. For this reason a randomized trial was conducted to compare three multiphasic oral contraceptives marketed in the United States.

Contraceptives, Oral↗
PubMed1987

Effects on hearing during prolonged oral contraceptive use.

Different hearing defects have been attributed to prolonged use of oral contraceptives. The aim of the present investigation has been the evaluation by means of a number of audiological tests and of brain-stem evoked responses (BSER) of the possible incidence of subclinical pathology of the nervous hearing structures in these subjects. Twenty healthy subjects taking oral contraceptives from 9 to 30 months and 10 paired controls have been studied. No hearing loss was found but the study of BSER showed the presence of a significantly shorter latency of waves I and III which could be attributed to a functional alteration. Other, less significant, alterations are described and the conclusion is reached that prolonged oral contraception does not affect the hearing function, even if it is investigated with sophisticated techniques. However, the significant alterations of BSER responses and of the stapedial reflex might be considered as an initial non-organic sign of impairment of the central hearing pathways and therefore deserve further investigation.

Acoustic Impedance Tests↗
PubMed1976

[A gradual method for a more physiological hormonal contraception].

The multiple physiologie stages of method by oral hormonal anticonception was reported, which have been in use in combination. Since 1969 about 362 women at the average age of 27,5 years received 10281 cycles, that means in an average cycles from 28,4 days, the stage method from 11/10 days or 7-7-7 days rhythmus.

Adult↗
PubMed1987

Oral contraceptive induced paraballism.

We report a case of paraballism in a young female, which became apparent 4 months after initiating oral contraception. When the oral contraceptive was discontinued, the paraballism decreased and was replaced by choreic movements for a period of approximately 2 weeks. The abnormal movements disappeared gradually. Only 13 cases of paraballism have been reported in medical literature, and none has been attributed to the use of oral contraceptives.

Adult↗
PubMed1989

The effects of two triphasic oral contraceptives on carbohydrate metabolism in women during 1 year of use.

Sixty-one women were randomly assigned to use one of two different triphasic oral contraceptives (OCs), for one year's time (Ortho Novum 777, Ortho Pharmaceutical Corp., Raritan, NJ, and Triphasil, Wyeth Laboratories, Philadelphia, PA), containing the progestins norethindrone and levonorgestrel, respectively. The carbohydrate metabolism was evaluated using the oral glucose tolerance test before OC use and at the end of the 12th month. Both plasma glucose and insulin levels were measured. The fasting glucose value in the norethindrone-containing OC group (777) was significantly lower at the 1-year testing. All other values were unchanged. These data demonstrate that the triphasic oral contraceptive preparations currently in use have minimal effects on carbohydrate metabolism.

Adult↗
PubMed1979

Immune reactivity of women on hormonal contraceptives: dinitrochlorobenzene sensitization test and skin reactivity to irritants.

To evaluate the influence of sex steroids on immunity in 87 women on hormonal contraceptives, sensitization tests were performed with the contact allergen, 2,4-dinitrochlorobenzene (DNCB). Forty-five women were taking oral contraceptives of combined oestrogen/progestogen of the same brand (low oestrogenic and middle range progestogenic activity); 27 had received intramuscular injections of medroxyprogesterone acetate and 15 women were using a sequential pill. The results were compared with those of 44 women not taking contraceptive steroids and matched for age. In women on the combined pill and those who had received intramuscular progesterone, the mean DNCB reactivity was significantly increased (0.02 less than p less than 0.05 and 0.001 less than p less than 0.01, respectively), whereas women using a sequential pill proved to show a decreased skin reactivity in the oestrogenic phase of this pill. (p = 0.05). The changes observed proved to be specific, since no statistically significant differences in overall skin reactivity to irritants between the four groups of women could be observed. The clinical implications of these results have been considered.

Adolescent↗
PubMed1989

Glucose and insulin levels after six months of treatment with a triphasic oral contraceptive containing ethinyl estradiol and norethindrone.

A prospective study of carbohydrate metabolism was done on 33 women who used a triphasic oral contraceptive (OC) containing ethinyl estradiol and norethindrone for six months. A three-hour oral glucose tolerance test was administered before and after the OC usage, and both the blood glucose and insulin levels were determined. A significant decrease in the fasting glucose level was found with treatment. All other glucose values and insulin levels were unchanged.

Adult↗
PubMed1983

Norethindrone in serum after use of an oral contraceptive containing norethindrone acetate.

The availability of norethindrone (NET) in serum was studied in 8 women after daily administration of a combination oral contraceptive pill (MinovlarR) containing 1 mg norethindrone acetate (NETA) and 50 micrograms ethinyl estradiol (EE2) from day 5 to day 25 of the menstrual cycle. The pill was taken daily at 9:30 a.m. after a light breakfast and blood samples were collected at 3 hr on alternate days and at 24 hr on other days after ingestion of the pill. On day 12 or day 15 of the first treatment cycle, serial blood samples were also collected at 1/2, 1, 2, 4, 6, 8 and 24 hr after taking the pill. Serum NET levels were estimated by the radioimmunoassay (RIA) technique. The plot of serum NET concentration versus time (0-24 hr) profile showed a rapid absorption of steroid and a peak NET concentration (18.3 +/- 4.8 ng/ml) reached at 2 hr after ingestion of the pill. By linear regression analysis of data (y = 0.27 + 0.12x; r = 0.95), it was observed that the serum NET level was initially about 1 ng/ml. Thereafter, it increased by 0.12 ng/ml per day up to 3.5 ng/ml by the end of 21 days' treatment with oral pills. The serum NET concentration decay slope fitted a two-compartment open model with an initial rapid decay (half-life of 1.2 +/- 0.1 hr) followed by a slower beta-phase with a half-life of 8.5 +/- 1.5 hr. The study revealed that there was an accumulation of norethindrone in plasma during the treatment period and this suggests the possibility of exploring a reduction in the dose of this preparation so as to achieve the optimum NET concentration for contraception, and thereby avoiding unwanted steroid accumulation in the plasma of women.

Adult↗
PubMedDate not supplied

[The effect of oral ovulation inhibiting (mono-, bi- and triphase) contraceptives and of Continuin and Postinor on proteo- and steroid hormones].

Endocrinological changes due to the effect of treatment with mono-, bi- and three-phase contraceptive pills taking continuously and occasionally are reviewed. It is established that oral contraceptives based on ovulation inhibition are safe. Less side effects are produced by Ovidon tablets. Continuin and Postinor pills are not safe, and they can produce irregular bleeding. Beside their numerous advances extrauterine pregnancy frequently happens (6.4%). A three-phase preparation is expected to have a reversible effect and lack of a consequent functional infertility. This is improved by hormone level measurements.

Adult↗
PubMed1989

Longitudinal ultrasonographic study of the ovarian suppressive activity of a low-dose triphasic oral contraceptive during correct and incorrect pill intake.

A longitudinal study was conducted to evaluate the ability of a low-dose triphasic oral contraceptive to suppress ovulation as documented by frequent ultrasonographic scanning and progesterone determinations, even in the event of a missed pill. The extent of follicular growth and maturation, the incidence of escape ovulation, and the effect of correct and incorrect pill intake were assessed in 30 evaluable women during two consecutive spontaneous menstrual cycles. After the first cycle, 11 of 30 women (36.6%) had follicle-like structures of at least 10 mm in diameter. Ten of 11 structures gradually disappeared during the second cycle, with one persistent structure remaining through the second cycle. Seven of 30 women (23%) developed follicle-like structures during the second cycle. Of these, one woman had a probable ovulation, and another had an elevated progesterone level without follicle rupture, suggesting the luteinized unruptured follicle syndrome. Both of these women missed a pill on day 1 of the second cycle. In all cases cervical scores indicating hostility were noted. Thus, although suppression of ovarian activity may have been incomplete when oral contraceptives were incorrectly taken, secondary mechanisms of contraception remained operant. When they were correctly taken, low-dose triphasic oral contraception consistently prevented ovulation.

Adult↗