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At least 523 records · Page 29Linked to original sources
PubMed1983

Clinical experience with a triphasic oral contraceptive ('Trinordiol') in young women.

Seven hundred and fifty cycles of treatment with a new triphasic oral contraceptive (WL-49(50). 'Trinordiol') containing the lowest quantity of steroids of all available preparations were evaluated in 75 healthy young women (mean age 19.6 years), 70% of whom had regular, normal cycles. Sixty-five percent had not used contraception before; the others had previously been on combined or progestagen-only oral contraceptives or had an IUD. The mean length of treatment with the triphasic preparation was 10 cycles. No pregnancy was recorded during the 750 cycles of treatment. Fifteen (20%) women dropped out of the study for medical reasons, essentially breast tenderness, weight increase, spotting and nausea, in decreasing order of frequency. Mastalgia was present in 21% of the women (8.9% of the cycles) during triphasic oral contraception, but this symptom disappeared in more than half of the cases within 3 months of continued use. Other side-effects were less frequent: vaginal discharge (4.4% of the cycles), nausea (3.7%), abdominal and leg cramps (2.8%), headaches (3.2%) and weight increase (3%). Spotting and breakthrough bleeding were reported during only 1.9% of the cycles, a remarkably low frequency. No absence of withdrawal bleeding was noted. Weight and blood pressure changes were minimal and never reached statistical significance. Hypertension developed during triphasic medication in 1 predisposed individual. Complaints of oestrogen-related symptoms such as breast tenderness and digestive disorders were probably due to the reduced progestagen content of the preparation compared with combined low fixed daily dose oral contraceptives. However, no increases in dysmenorrhoea and/or premenstrual tension were noted. It is concluded that the triphasic preparation provides effective contraception with excellent cycle control and minimal side-effects, which should help to increase the acceptability of low-dose combined oral contraceptives.

Adolescent↗
PubMed1984

A prospective controlled study of the effect on blood pressure of contraceptive preparations containing different types and dosages of progestogen.

A prospective controlled study investigated the effects of oral contraceptives on blood pressure in 485 women who were between 17 and 46 years of age and had blood pressures of less than 140/90 mmHg at entry. The women were divided into seven groups depending on the chosen method of contraception: intrauterine device or barrier method (control group): ethinyl oestradiol 30 micrograms plus levonorgestrel 150 micrograms (Microgynon-30 or Ovranette); norethisterone 350 micrograms (Micronor); norgestrel 75 micrograms (Neogest); norethisterone oenanthate 200 mg intramuscularly every 2 months for the first 6 months, then every 3 months thereafter; ethinyl oestradiol 30 micrograms plus ethynodiol diacetate 2 mg (Conova-30); and ethynodiol diacetate 500 micrograms (Femulen). Blood pressures were measured every 3 months by the family planning clinic nurse under standardized conditions using an Elag-Köln automatic sphygmomanometer. After one year, blood pressure had risen significantly (P less than 0.05) in the 137 women taking ethinyl oestradiol plus levonorgestrel (mean systolic and diastolic rises 6.4 and 2.7 mmHg respectively) and in the 91 women taking ethinyl oestradiol plus ethynodiol diacetate (mean systolic and diastolic rises 6.2 and 3.0 mmHg respectively). The 94 women taking the progestogen-only preparations and the 143 women in the control group showed no increases in blood pressure. These data were confirmed after 2 years of follow-up.

Adolescent↗
PubMed1984

Gender and oral contraceptive steroids as determinants of drug glucuronidation: effects on clofibric acid elimination.

The disposition of clofibric acid, a drug metabolised largely by glucuronidation, was studied in eight males, eight females and eight females receiving oral contraceptive steroids (OCS). Clofibric acid plasma clearance was not significantly different in males compared to the control female group but was 48% greater (P less than 0.01) in women receiving OCS compared to non-pill using females. This difference was due to an alteration in clofibric acid metabolic clearance as there were no differences between the groups in clofibric acid free fraction. Along with previous data the results suggest that induction of drug glucuronidation by OCS may be of clinical importance, although any sex-related differences are unlikely to be of clinical significance.

Adult↗
PubMed1982

Serum levels and pharmacokinetics of norethisterone after ingestion of lynestrenol: its relation to dose and stage of the menstrual cycle.

The peak concentration, peak time, the area under the serum concentration time curve (AUC) and half-life of serum norethisterone (NET) after a single application of lynestrenol (LYN) to female volunteers demonstrated that 0.7 mg NET is bioequivalent to 1 mg LYN which is rapidly converted to NET. There was a decrease of the peak values and an increase of half-life of NET during the periovulatory and luteal phase which was, however, not significant due to the great individual differences. The shift of the peak time to longer intervals and the increase of half-life of NET after ingestion of higher LYN doses indicate a certain limitation of the metabolic capacity of the liver. One of the volunteers who complained of nausea and vertigo after the administration of 5 mg LYN, showed the highest serum values of NET. The large interindividual variations of the serum levels of synthetic steroids demonstrate a possible risk of contraceptive safety in women with low steroid levels and possibly a coherence between extremely high serum levels of synthetic steroids and side effects.

Adult↗
PubMed1987

Presence of ethynyl-estradiol (EE-2) in blood and endometrium after interrupting steroidal contraception for three months.

Serial studies were conducted in five women under norgestrel + EE-2 after interrupting 11-34 months of regular use of the medication. A venous blood and an endometrial sample were simultaneously obtained from each subject between the 22nd and 25th day of the pseudocycle (last month of contraception) and on the same days of the following three cycles under no treatment for the measurement of EE-2 content. Values during and after the first month of no medication were: plasma = 85 +/- 6 versus 218 +/- 36 (pg/ml; P less than 0.001) and endometrium = 93 +/- 10 versus 29 +/- 7 (ng/g wet tissue; P less than 0.001). A decrement of circulating EE-2 from 346 pg/ml in the first month with no medication to 14 pg/ml in the third month off the treatment was observed. The EE-2 endometrial uptake of 93 +/- 10 (last month of steroidal ingestion) decreased to 29 +/- 7, 7 +/- 2 and 4 +/- 0.9 ng/g wet tissue in the following three months of no treatment. In 3/15 instances after interrupting contraception, circulating EE-2 was below the detection limit of the assay, while endometrial EE-2 uptake was in the range of 3-19 ng/g wet tissue. These data confirm our apparent controversial report that EE-2 plasma levels increased during the first month after interrupting medication and support the presence of the exogenous estrogen in plasma and endometrium after interrupting the steroidal contraceptive for three months.

Adult↗
PubMed1983

A comparative study of two estrogen dosages in combined oral contraceptives among Sudanese women.

A prospective study of two combined oral contraceptives was conducted in the Sudan. No pregnancies occurred. Overall incidence of side effects was low. Headache was most frequently reported. Elevations were observed for weight, systolic and diastolic blood pressures, and SGOT and SGPT values while a decrease was seen for hemoglobin levels. Menstrual irregularities were not a problem for the users. Total 6-month use discontinuation rates were low for both pill groups.

Contraceptives, Oral↗
PubMed1984

On the origin and histological structure of adenocarcinoma of the endocervix in women under 50 years of age.

In the last 10 years 28 adenocarcinomas of the endocervix developing in women up to the age of 50, have been encountered at our clinic. Of these women, 23 (82%) had taken oral contraceptives, in most instances continuously for up to 19 years, and for a median of 10 years. During the same period of time, 12 adenocarcinomas in situ of the endocervical mucosa were seen, 11 of which developed after 1 to 20 years of use of oral contraceptives. In contrast, only 40% of women with invasive squamous carcinoma under age 50 had used oral contraceptives. Fourteen of the 23 patients with invasive adenocarcinomas and 9 patients with adenocarcinoma in situ had taken contraceptives containing a potent gestagen, Norgestrel; the others had taken either Norethisterone acetate or Lynestrenol, usually in relatively high doses. Microscopically, the adenocarcinoma in the 28 women occurred in 3 forms, two of which did not appear in the 5 noncontraceptive users. In the women taking oral contraceptives, microglandular hyperplasia of the endocervix was diagnosed either prior to or coincident with the adenocarcinoma. The clinical observations are supported by experimental findings: 2 of 12 rhesus monkeys treated for 10 years with medroxyprogesterone acetate at doses 50 times those prescribed for women developed a similar type of adenocarcinoma. The longterm use of synthetic gestagens may be causally related to the development of endocervical adenocarcinoma.

Adenocarcinoma↗
PubMed1982

Cell turnover in the "resting" human breast: influence of parity, contraceptive pill, age and laterality.

Morphological identification of cell multiplication (mitosis) and cell deletion (apoptosis) within the lobules of the "resting" human breast is used to assess the response of the breast parenchyma to the menstrual cycle. The responses are shown to have a biorhythm in phase with the menstrual cycle, with a 3-day separation of the mitotic and apoptotic peaks. The study fails to demonstrate significant differences in the responses between groups defined according to parity, contraceptive-pill use or presence of fibroadenoma. However, significant differences are found in the apoptotic response according to age and laterality. The results highlight the complexity of modulating influences on breast parenchymal turnover in the "resting" state, and prompt the investigation of other factors as well as steroid hormones and prolactin in the promotion of mitosis. The factors promoting apoptosis in the breast are still not clear.

Adenofibroma↗
PubMed1983

Changes in plasma vitamin A in lactating and non-lactating oral contraceptive users.

Plasma vitamin A and retinol-binding protein (RBP) concentrations have been studied in women using oral contraceptives (OC) for up to 4 years. In eight women taking an oestrogenic OC(1 mg of norethisterone acetate + 50 micrograms of ethinyloestradiol) values almost doubled within 6 months, but diminished somewhat after 4 years. Saturation of RBP with retinol remained fairly constant. Five lactating women who took progestogen-only OC (30 micrograms of levonorgestrel or 350 micrograms of norethisterone) showed no significant alteration in plasma vitamin A or RBP concentrations as compared with nine lactating non-OC users. All lactating women showed significant differences between the highest and lowest plasma vitamin A (P less than 0.005) and RBP (P less than 0.05) concentrations during the first 6 months of lactation. Highest values occurred 11-12 weeks postpartum and the lowest at 15-17 weeks. Percentage saturation of RBP with retinol was significantly higher (P less than 0.005) when vitamin A concentration was highest.

Adult↗
PubMed1983

Sequential study of plasma euglobulin fibrinolytic activity during the normal menstrual cycle and in women on oral contraceptives low in estrogen.

Determinations of plasma euglobulin fibrinolytic activity were made in samples of plasma collected during one normal or hormone-simulated cycle in 15 young, normal women and in 11 women using an oral contraceptive low in estrogen. Distinct, individual levels caused the variations of fibrinolytic activity to be larger within the group than individually, and the activity showed only small changes during the cycle. The hormone group showed a marked increase in fibrinolytic activity with distinct fluctuations related to the phase of the cycle. This increase corresponded to that previously reported to be caused by oral contraceptives containing higher concentrations of estrogen.

Adult↗
PubMed1976

Contraceptive steroid toxicology in the Beagle dog and its relevance to human carcinogenicity.

Problems associated with the use of the Beagle dog in chronic toxicological studies of contraceptive steroids are described. A short review is presented on the occurrence of spontaneous tumours in dogs and in bitches of various breeds. The current status of knowledge of canine reproductive hormones and endocrinology is outlined, together with effects of contraceptive steroids. The pathology and histological classification of spontaneous and induced mammary neoplasia in the dog is discussed and compared with breast cancer in women. A series of recommendations are included for future research in this field which it is hoped may resolve some of the outstanding issues and lead to a more suitable toxicological model for contraceptive steroids.

Animals↗
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↗