Do vaginal spermicides cause birth defects?
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Serum levels of androstenedione, dihydrotestosterone, and testosterone were determined by radioimmunoassay procedures in 25 female volunteers using subdermal levonorgestrel implants as a contraceptive. Mean serum androstenedione levels were increased after 1 and 6 months in comparison with preimplantation levels, the increase being significant only after 1 month. This could be attributed to increased production from the adrenal or ovaries and/or changes in clearance rate. Testosterone levels showed approximately 24% increase above basal values after 6 months' use of levonorgestrel implants, which was attributed to concomitant increases in androstenedione levels. The implication of these results is discussed.
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Using home-made match kits and radioimmunoassay, both serum luteinizing hormone (LH) and testosterone (T) were measured in 53 healthy adult males using microwave contraception and 76 normal fertility males as control. The results showed that in contraceptive group the serum T level was significantly decreased (p 0.0001), while serum LH was apparently elevated (p 0.01) as compared whith the normal controls. Furthermore, the longer exposure duration the lower serum T declined and the higher serum LH increased (p 0.001). The present study suggests that the microwave dose used for contraception seems to cause damage in Leydig cell function in terms of T production, and then influence endocrine function of testis. The progressively increased LH level also indicates certain degree damage of the Leydig cells. However, the damage might be reversible. The results may be useful for further clinical investigation.
Mean serum zinc (1.14 micrograms/ml) and copper (2.35 micrograms/ml) in 24 women taking oral contraceptive agents were compared against mean serum zinc (1.25 micrograms/ml) and copper (1.98 micrograms/ml) of 20 women of the same age range who served as controls. Serum zinc was significantly lower while serum copper was significantly higher for women taking the oral contraceptive agents. There was no significant correlation between the serum zinc and copper levels either in the control group (r = 0.04) or in the group taking the contraceptives (r = 0.36).
The synthesis of eighteen esters of norethisterone (17 alpha-ethynyl-17 beta-hydroxyestr-4-en-3-one) is described. These all possess some form of alpha- and/or beta-substitution in the ester side-chain. The work was undertaken in order to evaluate any long-acting fertility control effect intrinsic in such compounds. A pentamethyl disiloxy ether was also included in the group of substances prepared for testing because of its similar substitution pattern.
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Hepatocellular carcinoma (HCC) developed in two women who had ingested oral contraceptives for prolonged duration. One of the patients had hepatoma restricted to the liver, and it was successfully resected. The other patient presented with metastatic HCC to the sacrum and lung, and she died after an initial response to chemotherapy in 12 months. Review of literature showed 23 previously reported cases of HCC associated with "pill" use since 1973. Although the reported instances of HCC in pill users are few in number, the majority of affected females were in their 20s and early 30s, without any preexisting liver disease. Even though the risk of developing HCC on oral contraceptives is low, this association adds to the list of complications induced by oral contraceptives in premenopausal women. Two cases are reported and literature reviewed.
A clinical study concerning the vaginal contraceptive efficacy of gossypol acetic acid was performed. Fifteen women who had undergone tubal sterilization volunteered for the study. The effect of vaginal gossypol-containing gel on spermatozoa was determined by postcoital tests performed in subjects without and after using gossypol gel. After gossypol application, the number of spermatozoa found in cervical mucus was greatly decreased and, in eleven of the fifteen women, all spermatozoa seen were immobilized. In four cases a few poorly motile spermatozoa were seen but they showed no forward progression. We have previously reported that gossypol has an inhibitory effect on herpes simplex virus type 2 in vitro. This anti-viral property of gossypol makes it particularly attractive as a topical barrier contraceptive. The present study shows that gossypol is also promising as a vaginal contraceptive agent in human in vivo experiments.
Plasma levels of levonorgestrel, sex hormone binding globulin (SHBG) and estradiol were studied during four years in 283 healthy women using either NORPLANT implants or two covered rods (NORPLANT-2). The women were randomized to use either type of implant. Both implant systems have previously been shown to have similar release rates of levonorgestrel. In both groups plasma levels of levonorgestrel decreased throughout the study, and there were no statistically significant differences between the two groups in mean plasma levels of levonorgestrel. During the study 8 women became pregnant. All pregnancies but one occurred after 35 months of implant use and only in women using the covered rods. No significant differences were seen between the women who became pregnant and the rest of the group using two covered rods with respect to plasma levels of levonorgestrel. SHBG capacity tended to be somewhat higher in women using the two covered rods. As levonorgestrel is to a great extent bound to SHBG, and in that form not biologically active, a "free levonorgestrel index" was calculated as a ratio between levonorgestrel and SHBG. This index was significantly lower in users of two covered rods than in users of NORPLANT implants at 1, 12 and 48 months of use. Women who became pregnant had significantly lower "free levonorgestrel index" than had the rest of the group. It is postulated that the difference in "free levonorgestrel index" between users of the two implant systems reflect differences in release rate, the covered rods having a lower release rate of levonorgestrel than NORPLANT throughout the observation period. It is concluded that "free levonorgestrel index" is a better parameter than levonorgestrel plasma levels to describe implant function, and to discriminate women who are at risk of pregnancy.
Levonorgestrel which binds with high affinity to SHBG, is suggested as a new radioligand for estimation of SHBG in human plasma. Using 3H-levonorgestrel as a ligand, a number of samples from men, women pregnant and non-pregnant were analysed. The SHBG content was lowest in men, low in women and rose to higher level during pregnancy. The results of the present study suggest that levonorgestrel appears to be a better ligand than dihydrotestosterone for measuring SHBG.