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Galactorrhea in DMPA users: incidence and clinical significance.
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[Current trends in the development of oral contraception].
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[Comparative determination of norethisterone in the blood plasma by radioimmunological and chromato-mass fragmentographic methods].
Radioimmunoassay (RIA) and two variants of the chromato-mass fragmentographic (CMF) method were used for comparative determination of norethisterone (NET) in the blood plasma. A deuterated internal standard, capillary gas-liquid chromatography and chromatographed derivates: 3-enol-3-tret-butyldimethylsilyl-17-tri-methysilyl and 3-enol-3,17-bis-tret-butyldimethylsilyl NET esters were used. Both derivates provide for CMF determination after simplified variants. They were used as references for RIA determination of NET. Comparison of the CMF and RIA results indicate to the significance of RIA determination (r = 0.979) while employing antiserum to NET conjugate 3-(0-carboxymethyl)-oxime with bovine serum albumin injected to rabbits.
[Iatrogenic pathology of the optic nerve].
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Effects of oral contraceptives on the oral structures: a review.
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[Problems of the effect of peroral contraceptives on intravascular coagulation].
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Long-term effects of MPA on human progeny: intellectual development.
Tests of verbal and spatial ability were done on 450 boys and 537 girls in their late teens of whom 73 and 97, respectively, had been exposed in utero to MPA. Exposed boys achieved higher raw scores than controls on verbal and spatial tests but the differences were explained by their more favorable demographic and social characteristics. Exposed girls did not differ from controls. Although, mothers of exposed boys reported that their offspring talked and walked later than controls, our results support the hypothesis that intrauterine exposure to MPA at contraceptive doses has no long-term effect on intellectual development.
Lack of an elevated risk of malignant melanoma in relation to oral contraceptive use.
Epidemiologic and laboratory data suggest an effect of oral contraceptives (OC) on the risk of malignant melanoma. This relationship was explored in a hospital-based case-control study of 160 women with malignant melanoma and 640 matched controls, all of whom were white and 20-59 years of age. A total of 63 cases (39%) had used OC compared with 270 controls (42%), yielding a relative risk estimate of 0.9 (95% confidence interval: 0.6-1.3). When a number of potential confounding factors were simultaneously controlled, the relative risk estimate was 0.8 (0.5-1.3). For use that lasted 5 or more years the estimate was 0.9 (0.5-1.6). The level of tumor invasion was not related to OC use. The evidence from this study suggests that OC, even when used for 5 or more years, do not increase the risk of malignant melanoma.
The effects of Depo-Provera on serum protein levels in Nigerian women.
The concentration of 13 serum proteins were determined in 50 women who had received the 3-monthly intramuscular injection of Depo-Provera for contraception over a mean period of 18 months and 40 women of comparable ages who served as controls. Sera from fasting subjects were used to determine the levels of each specific protein by quantitative immunodiffusion technique. Treatment with Depo-Provera produced increased serum levels of albumin, alpha 1-acid glycoprotein, alpha 2-macroglobulin, haptoglobin IgG; reduced levels of alpha 1-antitrypsin, transferrin, C3c, C4 but no change in serum IgA, IgM, C-reactive protein and ceruloplasmin. The significant alterations were observed in serum proteins that are notably synthesized by the liver, an observation consistent with the influences which gonadal hormones exert on the metabolic activities of this organ.
Interactions of antiestrogens with human breast cancer in long-term tissue culture.
A variety of antiestrogens can be shown to antagonize estrogen action in animal model systems. Several of these compounds are useful in the management of metastatic human breast cancer. To further elucidate their mechanism of action, we studied several of these compounds using human breast cancer cell lines maintained in long-term tissue culture as a model system. Antiestrogens including tamoxifen (NSC-180973; ICI-46474), nafoxidine. CI-628, and clomiphene citrate inhibit macromolecular synthesis below control levels in two human breast cell lines. This effect is limited to cell lines which contain estrogen receptors. Simultaneous addition of as little as 1000-fold less estradiol prevents antiestrogen effects. Sequential addition of estrogen for up to 48 hours to cells incubated in antiestrogen reverses inhibition. If cells are continued in antiestrogen alone for more than about 3 days, inhibitory effects become irreversible. The cells detach from the surface of the culture vessel and are no longer viable. Tamoxifen competes with 3H-estradiol for specific receptor sites but with about a 100-fold lower apparent affinity. Direct binding of 3H-tamoxifen and 3H-estradiol to duplicate cytoplasmic extracts reveals equivalent numbers of binding sites but a 20-fold lower affinity for the antiestrogen. There is reasonable agreement between concentrations of tamoxifen which bind to receptor and concentrations which inhibit cells.
Differential effects of oral contraceptive steroids on the metabolism of benzodiazepines.
The effects of oral contraceptive steroids (OCS) on the disposition and elimination of lorazepam, oxazepam, and chlordiazepoxide were examined. Lorazepam and oxazepam are metabolized via glucuronidation while chlordiazepoxide is metabolized by oxidation in the liver. The disposition and elimination of lorazepam, oxazepam, and chlordiazepoxide was studied in females not taking OCS and females taking OCS (norethindrone acetate, 1 mg; ethinyl estradiol, 50 micrograms) for 6 months or more. The t1/2 (beta) for lorazepam was significantly reduced in women taking OCS (6.0 +/- 3.1 vs. 14.0 +/- 6.2 hr) (p less than 0.005) as compared to controls, and the t1/2 (beta) for oxazepam was reduced in women taking OCS (7.71 +/- 3.23 vs. 12.09 +/- 5.08 hr) as compared to controls, but did not reach statistical significance. The plasma clearance of both lorazepam and oxazepam was significantly increased in women taking OCS [(288.9 +/- 165.9 vs. 77.5 +/- 3.29 ml per min) (p less than 0.01) and (251.2 +/- 106.9 vs. 97.86 +/- 69.4 ml per min) (p less than 0.01), respectively] as compared to controls. The volumes of distribution of lorazepam and oxazepam were significantly increased in women taking OCS (p less than 0.05) while plasma binding of these drugs was similar in both groups. In contrast, the t1/2 (beta) of chlordiazepoxide was significantly prolonged (20.58 +/- 8.08 vs. 11.63 +/- 5.91 hr) (p less than 0.05), and the plasma clearance was significantly reduced (13.41 +/- 4.69 vs. 33.22 +/- 12.37 ml per min) (p less than 0.05) in the OCS group as compared to controls. The volumes of distribution of chlordiazepoxide were similar in both groups, and the plasma binding of chlordiazepoxide tended to be lower in the OCS group but did not reach statistical significance. We conclude that OCS exert a differential effect on the elimination of benzodiazepines, whereby oxidation of chlordiazepoxide is impaired while the glucuronidation of lorazepam and oxazepam is enhanced by OCS.
Estradiol plasma levels during long-term treatment with Norplant subdermal implants.
Estradiol-(E2) plasma levels were assessed in forty-seven women treated for one through seven years with the same set of Norplant implants. Each woman was subjected to one (n = 34), two (n = 11) or three (n = 2) sampling runs. At each sampling run, blood samples were drawn every third or fourth day during 5 or 6 consecutive weeks. Sampling runs were classified as ovulatory (n = 11), anovulatory (n = 49) or uncertain (n = 1) according to progesterone levels. Controls were Copper T users (n = 8), all classified as ovulatory. No significant differences were found for the mean E2 levels between Norplant users and Copper T users and between ovulatory and anovulatory cases. The mean of the peak E2 value found in each sampling run was significantly higher in anovulatory Norplant subjects than in the control group. The mean of the minimum E2 level observed was significantly lower in Norplant cases than in Copper T users. A single woman from the Norplant group and none from the Copper T group had all E2 values below 370 pmol/l. The inhibition of the reproductive function induced by Norplant implants is associated with a wider range of E2 circulating levels. None of the values observed at the extremes should cause serious concerns. High peaks are transitory and opposed by the antiestrogenic effect of levonorgestrel. Persistent low levels which could be associated with a hypoestrogenic state were observed in a single case.
Effect of tamoxifen alone and in combination with RU 486 on the endometrium in the mid-luteal phase.
The effects of RU 486 combined with tamoxifen and tamoxifen alone on hormonal parameters and endometrial development at the time of implantation were studied. Measurements of cytosolic oestrogen and progesterone receptors in endometrium and placental protein 14 (PP14) in plasma were also included. Three dosage schedules were used: single oral dose of 40 mg tamoxifen alone and in combination with 200 mg RU 486, and 40 mg tamoxifen for three consecutive days starting on the first day after the luteinizing hormone (LH) surge. The combined treatment prolonged the luteal phase (P < 0.05) and increased the plasma levels of progesterone. A single dose of tamoxifen did not affect the bleeding pattern and plasma hormone levels, but raised plasma oestradiol and LH with the 3-day treatment. The endometrium was retarded after the combined and the 3-day treatment with tamoxifen. Concentrations of cytosolic progesterone receptors were higher after the combined therapy, but were unaffected after tamoxifen only. PP14 levels were higher (P < 0.05) after repeated tamoxifen doses than in controls, but were lower with combined treatment. Progesterone and oestrogen are evidently necessary for endometrial maturation during the secretory phase of the menstrual cycle. PP14 levels in plasma cannot be used for clinical assessments of endometrial function because high levels coincide with disturbed endometrial development.
The use of a contraceptive vaginal ring governed by the pattern of individual uterine bleeding.
Contraceptive vaginal rings (CVR) releasing levonorgestrel and estradiol were used for contraceptive purposes in eight women. They were instructed to remove the CVR for five days only, in the case of bleeding. Three selected subjects were followed by plasma sampling during the first 60 days of treatment. Plasma concentrations of levonorgestrel, progesterone, estradiol and gonadotropins were determined. All subjects kept bleeding records and were controlled clinically in the course of treatment. The subjects were protected an average of 163 days by the CVR. Three subjects used the CVR 170--180 days without removing it and two subjects had to remove the CVR only once. Two subjects experienced quite regular bleedings, and metrorrhagic bleeding was present in one case. No pregnancies were observed during the follow-up period of 1304 days. Clinical examination revealed no pathological findings. The vaginal mucosa tolerated the treatment well. Out of those subjects who were followed by plasma sampling, pituitary suppression was more marked in the subject with continuous use of CVR.
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.
Pituitary, ovarian and endometrial effects of progesterone released prematurely during the proliferative phase.
The pituitary, ovarian and endometrial effects of premature exposure to progesterone during the proliferative phase were investigated in 18 normally menstruating women. Daily blood samples were drawn during a control cycle and an endometrial biopsy was obtained on cycle day 6 (in 9 subjects) and on cycle day 11 (in 9 subjects), respectively. Daily blood samples were drawn again throughout a treatment cycle, in which a vaginal delivery system releasing progesterone at a constant rate of 1.4 mg/24 h was inserted and left in situ for 96 hours during cycle days 2-6 (9 subjects) and cycle days 7-11 (9 subjects), respectively. On the 6th and 11th cycle day, respectively, the devices were removed and another biopsy specimen was obtained. In all blood samples the levels of immunoreactive lutropin (LH), estradiol (E2), 17-hydroxyprogesterone (17-HO-P), progesterone (P) and 20 alpha-dihydroprogesterone (20 alpha-HO-P) were estimated by radioimmunoassay. Insertion of the devices resulted in a rapid, approximately six-fold increase (from 0.5 to 3.0 nmol/l) in P levels and an approximately three-fold (from 0.5-0.6 to 1.5-2.0 nmol/l) increase in 20 alpha-HO-P levels. A high degree of correlation was found between P and 20 alpha-HO-P levels. No major changes were observed in the profiles and levels of the other hormonal indices studied. However, premature exposure to small amounts of P during cycle days 2-6 resulted in a significant decrease in the ratio of the E2 to LH peaks and exposure during cycle days 7-11 gave rise to a significant increase in the ratio of the length of follicular to luteal phases. Progesterone released during the early proliferative phase (days 2-6) exerted little, if any, effect on the appearance of the endometrium. However, the same dose of P released during the late proliferative phase (days 7-11) significantly diminished the number of glandular mitoses, the height of the glandular epithelium, reduced pseudostratification and the number of plasmolemmal vesicles, but did not induce any subnuclear vacuolation, predecidual reaction or leucocytic infiltration. It is suggested that systematic studies involving the exposure to progestogens in normally menstruating women during cycle days 7 to 11 will provide a reliable and practical method for the comparative assessment of the potency profile of individual progestogens in women.
The effects of cyproterone acetate and ethinyl oestradiol on carbohydrate metabolism.
Carbohydrate metabolism was studied in a group of 66 women, taking cyproterone acetate (CA) and ethinyloestradiol (EO) as anti-androgen therapy for the treatment of hirsutism and/or acne. A reverse sequential treatment cycle was used and women were studied in two groups: the first when taking the combination of CA and EO during the first 12 days of the treatment cycle, and the second taking EO alone during days 13 to 22. The combination reduced fasting plasma glucose and raised fasting plasma insulin concentrations. There was deterioration of glucose tolerance with increased plasma insulin concentrations and these effects were progressive with time. The plasma insulin response to intravenous tolbutamide was increased by 50% but there was no accompanying change in the glucose nadir as compared with controls. These results show that the combination of CA and EO causes insulin resistance. Plasma C-peptide concentrations following oral glucose were unchanged compared with controls. This shows that the observed hyperinsulinaemia was due to a reduction of hepatic uptake of insulin rather than its increased secretion. We propose that these effects are due to a CA-induced elevation of fasting plasma insulin resulting in downregulation of hepatic insulin receptors with subsequent induction of insulin resistance and impairment of hepatic insulin uptake. C-peptide concentrations following i.v. tolbutamide were significantly higher on treatment with CA and EO than in controls indicating increased pancreatic secretion of insulin. Tests carried out while patients were taking EO alone showed impairment of glucose tolerance only with no change in insulin levels. There was an increase in plasma insulin in response to tolbutamide but this was not significant. We conclude that these results are explained by a reduced but persisting effect of CA.