Prospective experience with a levonorgestrel implant--Norplant.
Explore the source record for details and available documents.
SEARCH · PubMed Health
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Explore the source record for details and available documents.
Four-hundred-twenty-six women, aged 18 to 36, completed a four-cycle comparative, randomized, single-blind (observer blind), multicenter study of a new graduated estrogen formulation with three constant-dosed combination oral contraceptives containing the same synthetic steroid compounds. The products studied were Loestrin 1/20, Loestrin 1.5/30, Norlestrin 1/50, and a new graduated estrogen product, Estrostep. A total of 1,850 cycles were completed and analyzed for efficacy, side effects, metabolic changes, and cycle control. Four pregnancies occurred during the course of the study. None of the pregnancies occurred in the group receiving Estrostep. The new formulation produced the lowest rate of breakthrough bleeding (BTB) compared with the other three products. All four combination oral contraceptives resulted in an increase in high-density lipoprotein cholesterol (HDL-C). The levels of HDL-C were greatest with Estrostep.
Recent studies have demonstrated that many patients with SLE have elevated plasma levels of the minor oestrogen metabolite 16 alpha-hydroxyestrone (16 alpha OHE). This oestrogen is unique in its ability to react with lysine residues and form stable, covalent Heyns products with proteins. Increased levels of 16 alpha OHE-modified proteins have been found to occur on the membranes of red cells and lymphocytes in patients with SLE. In the present study, patient and control sera were analysed for the presence of circulating immunoglobulins which react with an oestrogen hapten. Anti-oestrogen antibodies were detected in 26% (9/34) of male and female SLE patients, and were found to correlate both with levels of plasma 16 alpha OHE (P less than 0.001) and with the presence of active disease (P less than 0.005). Surprisingly, this antibody activity was also observed in 25% (13/52) of normal, disease-free women who had a history of oral contraceptive use. No detectable activity was observed in normal men, women who had not taken oral contraceptives, or patients with a variety of other immunological diseases. The possible role of anti-oestrogen antibodies in both the hormonal exacerbation of SLE and in the long-term sequelae of oral contraceptive usage is discussed.
The effect of a low-dose triphasic oral contraceptive (OC) containing ethinyl estradiol and levonorgestrel (EE/NG) upon serum levels of endogenous sexual hormones was compared to that of a preparation containing EE and desogestrel (EE/DG). Blood samples were taken on Day 6, 11, 21, and 28 of a control cycle and of the third cycle of treatment with either the EE/NG or EE/DG preparation (11 volunteers each). After a washout period of 3 months, the contraceptives were changed in a cross-over fashion. Blood samples were again taken on Day 6, 11, 21, and 28 of the third washout cycle and the third treatment cycle. There was no significant suppression of serum LH and FSH during treatment with EE/NG and EE/DG except on Day 21, while estradiol levels were significantly lowered. Similar to the gonadotropin concentrations, the estrogen levels showed great individual variations; although they were depressed in the majority of the women, there was a considerable stimulation of follicular activity in 36% of the women under EE/NG and 18% under EE/DG. Both EE/NG and EE/DG suppressed significantly serum progesterone, testosterone, and DHEA-S, while prolactin was unaffected. In three cases an escape ovulation seemed to have occurred, but no pregnancy was observed. The spottings (8/22 women) and breakthrough bleedings (6/22 women) did not correlate with the serum levels of estradiol. The results indicate that the suppression of gonadotropin secretion during treatment with low-dose OC is a time-dependent process which in some women may be at or below the threshold of safe ovulation inhibition.
The effect of a low-dose triphasic oral contraceptive (OC) containing ethinyl estradiol and levonorgestrel (EE/NG) upon thyroid function and some other biochemical serum parameters was compared to that of a preparation containing EE and desogestrel (EE/DG). Blood samples were taken on Day 6, 11, 21, and 28 of a control cycle and of the third cycle of treatment with either the EE/NG or EE/DG preparation (11 volunteers each). After a washout period of 3 months, the contraceptives were changed in a cross-over fashion. Blood samples were again taken on Day 6, 11, 21, and 28 of the third washout cycle and the third treatment cycle. There was a significant increase (13%) in basal glucose level during treatment with both OC, but no change in glucose tolerance. Both the EE/NG and FE/DG preparation elevated serum T4 (40%), FT4 (15-22%), T3 (17-28%), and TBG (20%) significant, whereby the effect was more pronounced during the second treatment period after washing-out. The effective thyroxine ratio (ETR) was slightly (4%) but significantly increased. Contrary to this, the levels of FT3, reverse T3 (rT3), TSH, and gastrin were not altered. STH showed great individual fluctuations, but was significantly elevated by 50% during treatment with both OC. There was no effect of endogenous estradiol upon thyroid or other parameter, even though it was raised considerably in some women under OC. Although the increase in T4 and T3 is probably due to a rise in estrogen-induced TBG production, the data seem to indicate that there is a slight but effective stimulation of thyroid function during treatment with low-dose OC.
A postcoital contraceptive with a lower incidence of nausea and vomiting than oestrogen-progestogen combinations would be a significant advance. During a nine-month period, 101 women were treated at the Margaret Pyke Centre in London with either an oestrogen-progestogen combination or with danazol. A comparison of the side effects of each drug is reported. Those treated with danazol were six times less likely to experience nausea and none vomited. With the exception of breast symptoms, other side effects were five times less common in women receiving danazol. These differences give danazol a clear advantage in terms of patient acceptability. Further experience will enable the efficacy of danazol to be evaluated and so determine whether this drug should become the preferred hormonal postcoital treatment.
The effects of a single dose of two antimalarial drugs chloroquine (CQ) and primaquine (PQ) on the pharmacokinetics of a combined oral contraceptive (O.C.) have been studied in volunteers. Each woman was studied on 3 separate occasions over 3 cycles and plasma concentrations of ethinyloestradiol (EE2) and levonorgestrel were measured by radioimmunoassay following administration of a single dose of O.C. (30 micrograms EE2 + 150 micrograms levonorgestrel) in the absence and presence of the antimalarial drugs (PQ, 45 mg; CQ, 300 mg). Neither CQ or PQ given 1 h before the O.C. had any significant effect on plasma concentrations of EE2 or levonorgestrel or on any pharmacokinetic parameter determined. There is therefore, no evidence that CQ or PQ interfere with the hepatic handling of O.C.'s. This is in contrast to previously reported inhibitory effects of PQ on the metabolism of antipyrine.
Millions of healthy women use combined oral contraceptives (o.c.) for decades. In spite of that, little is known about their possible effects on cognitive functions. In this open cross-over study, 20 women were examined twice at four-week intervals at a fixed period of the menstrual cycle when they were and when they were not taking o.c. They were examined with a test-battery to assess cognitive functions. Blood samples were taken before and after breakfast to assess levels of oxytocin and prolactin. A significant increase in levels of oxytocin was registered when the women were on o.c. There was no significant difference in performance on the psychometric tests when the participants were on o.c. compared to when they were without o.c.
Explore the source record for details and available documents.
The variability of the female urethral pressure profile as determined with the microtransducer technique was studied in a group of healthy nulliparous women according to a standardized methodology. Estimation of the short term reproducibility, as well as investigation of which of several serially recorded urethral pressure profiles can be considered as most representative of the basal condition, was carried out by performing serial urethral pressure profile recordings within the same study session in 12 women. Estimation of the long term reproducibility and investigation of the influence of axial rotation of the transducer membrane on the measurements were carried out in 20 women who were on low dose oral contraceptives. No influence of low dose oral contraceptives on the urethral pressure profile measurements could be detected. When serial recordings were made within the same study session, the lowest values for the urethral closure pressure were generally observed in the 3rd and 4th recordings. The short term and long term reproducibility of urethral pressure profile measurements were generally the same for the measurements in both the supine and the sitting positions. Rotation of the transducer membrane as well as positional changes significantly influenced the urethral pressure profile recordings. The recordings in which the transducer was oriented ventrally generally showed a shorter urethral length and a higher closure pressure than those in which the pressure transducer was oriented laterally or dorsally. These observations as well as the observations made during dynamic testing indicate an asymmetrical distribution of urethral closure forces in healthy nulliparous women.
Epidemiologic evidence has linked diet to breast cancer, with the highest cancer rates observed in women who eat a high fat-low fiber diet. There is also substantial information, both clinical and experimental, that implicates estrogens in the etiology of breast cancer. A recent study from our laboratory has shown that diet influences levels of estrogens, and the main mechanism is metabolism of estrogens in the intestine. The intestinal microflora plays a key role in the enterohepatic circulation of estrogens by deconjugating bound estrogens that appear in the bile, thereby permitting the free hormones to be reabsorbed. By suppressing the microflora with antibiotic therapy, fecal estrogens increase and urinary estrogens decrease, changes indicating diminished intestinal reabsorption. A low fat-high fiber diet is associated with similar findings-high fecal estrogens and low urinary estrogens. It appears that the microflora plays a key role in the metabolism of female sex hormones.
Explore the source record for details and available documents.
Thirteen women aged 36-46 years (mean 43) who were seeking contraceptive advice, were monitored for 3 months with basal body temperature (BBT) and were then treated for 3 months with CyclabilR (11 tablets of 2 mg estradiol valerate (E2) followed by 10 tablets of 2 mg E2 + 0.5 mg norgestrel). This treatment was immediately followed by another 3 months with CyclabilR + 2 mg E2. BBT revealed a spontaneous ovulatory rate of 89%. Cyclabil reduced the ovulatory rate, as measured with repeated serum progesterone analyses, to 37%, and Cyclabil + 2 mg E2 resulted in a marked reduction in the number of ovulations (3%). Both types of hormonal combination resulted in relatively small changes in Sex Hormone Binding Globulin Capacity. It is concluded that the addition of 2 mg E2 to CyclabilR causes a decrease in ovulation rate to such an extent that women using this combination run a relatively small risk of conceiving. One advantage over contraceptive steroids may be that the present combination contains a natural estrogen at a relatively low concentration.
Explore the source record for details and available documents.
This study was designed to report changes in circulating FSH, LH, and prolactin levels in women users of subdermal levonorgestrel implants. The subjects comprised 21 women implanted with 6 silastic rods, each containing 34 mg levonorgestrel, between days M0 and M+4 of the menstrual cycle. Blood samples were drawn prior to, 1 month and 6 months after implantation, during the early follicular phase in menstruating (n=12), and randomly in amenorrheic (n=9) subjects. No significant differences were noted between the mean values of estimated hormones at the 3 intervals of estimation in both regularly menstruating and amenorrheic groups.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.