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PubMed1979

Endocrinology of reproduction in the female beagle dog and its significance in mammary gland tumorigenesis.

On the basis of the results of investigations from systemic tolerance tests (and carcinogenicity studies), an attempt is made to evaluate the effects of various progestagens, oestrogens and progestagen-oestrogen combinations on the mammary gland of the dog. The interpretation of such effects in the dog and its relevance in predicting a tumorigenic effect of contraceptive steroids in man is discussed in the light of comparative endocrinology of reproduction. The induction of mammary gland tumours in dogs by certain progestagens or progestagen-oestrogen combinations must be considered as being a species-specific effect, related to the high hormonal potency (progestational activity) of these compounds in the dog and their stimulatory effect on canine growth hormone. Based on the present state of our knowledge and because of the marked interspecies differences of action of contraceptive steroids in dog and man, the steroid-related canine mammary tumours, especially with regard to the doses necessary for contraception, are unlikely to be indicative of a potential hazard to the human female.

Animals↗
PubMed1998

Lipid effects of an intrauterine levonorgestrel device or oral vs. vaginal natural progesterone in post-menopausal women treated with percutaneous estradiol.

BACKGROUND: The ideal progestin for combined hormone replacement therapy should be free of adverse effects on lipid metabolism. We therefore examined lipid profiles during continuous hormone replacement therapy (HRT) with an estradiol-gel combined with either a levonorgestrel-releasing intrauterine device (LNG-IUD) or oral/vaginal natural progesterone. METHODS: Sixty menopausal women recruited in this open, non-randomised parallel three-group study received percutaneous gel containing 1.5 mg of estradiol daily. Progestin was administered to the women with an LNG-IUD (n = 20), as oral natural progesterone (n = 21) 100 mg daily on the 1-25 calendar days of the month or as vaginal progesterone (n = 19) 100-200 mg daily on the 1-25 calendar days of the month. Serum concentrations for total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and sex hormone binding globulin (SHBG) were measured at 0, 6 and 12 months. The median (and 95% confidence interval) of the serum SHBG, total, LDL-, HDL- cholesterol and triglycerides concentrations at baseline and after 6 and 12 months of the study and the ratio of 6 and 12 months values to baseline values were calculated. RESULTS: Total cholesterol was significantly decreased (8%) in the vaginal progesterone group at the end of the trial. HDL-cholesterol did not change in either of the progesterone groups, while a slight but transient decrease (median 15%) was seen at 6 months in the LNG-IUD group. There were no significant changes in triglycerides or LDL-cholesterol concentrations in any group. SHBG did not change significantly in the LNG-IUD and vaginal progesterone groups, while a slight but transient increase was seen in oral P group at 6 months. CONCLUSIONS: As the only significant harmful effect observed was a transient decrease in HDL-cholesterol in the LNG-IUD group at 6 months, each of these HRT-administration methods can be regarded as being safe in their effects on lipid metabolism.

Administration, Cutaneous↗
PubMed1990

Interactions with oral contraceptives.

The interaction of a range of different factors with the pharmacologic activity of oral contraceptives is reviewed. Pharmacokinetic interactions with oral contraceptives may occur (1) during absorption and extrahepatic circulation, (2) by interfering with protein binding, and (3) during hepatic metabolism. The hepatic mixed function oxidase system, which is mainly responsible for the metabolism of oral contraceptives, is affected by several different factors and is easily induced. Nutrition affects the activity of many drugs, but information regarding oral contraceptives is meager. Both pharmacokinetic and pharmacodynamic interactions, which may be synergistic or antagonistic, between the estrogen and gestagen components of oral contraceptives, are important, but there is no correlation between the rate of metabolism of the two components. Evidence suggests that some anticonvulsant, antibiotic, and antibacterial drugs may reduce the efficacy of oral contraceptives. Instances of interactions of other therapeutic agents are reported infrequently. The incidence of serious interactions is low and does not appear to have been reduced with low-dose oral contraceptives, probably because of large intersubject variability in the pharmacokinetics of oral contraceptives.

Blood Proteins↗
PubMed1990

Gastrointestinal disease and oral contraception.

Oral contraceptive steroids play a major role in modern family planning. With the present tendency to decrease the doses of both estrogens and progestogens, any factor that reduces the bioavailability of the lower-dose preparations may have an impact on contraceptive protection. Although ethinyl estradiol, the most commonly used oral estrogen, is liable to an enterohepatic circulation as unchanged drug, the commonly used progestogens are not. At present, no convincing evidence exists in the human subject that disruption of the enterohepatic circulation by antibiotics or antacids does reduce contraceptive efficacy of the pill. Oral contraceptive steroids are mainly absorbed from the small bowel, and contraceptive efficacy depends on its absorptive capacity. Enhanced passage of gastrointestinal contents or impaired absorption may thus contribute to contraceptive failures in patients who have chronic inflammatory disease, diarrhea, ileostomy, or jejunoileal bypass.

Antacids↗
PubMed1990

Oncogenic transformation by human papillomavirus type 16 deoxyribonucleic acid in the presence of progesterone or progestins from oral contraceptives.

Compelling evidence supports a role of certain types of human papillomaviruses as the cause of cervical cancer. In addition to human papillomaviruses, other agents, such as hormones, have been implicated as cofactors in this type of neoplasia. In this study we provide evidence for oncogenic transformation of primary baby rat kidney cells by human papillomavirus type 16 deoxyribonucleic acid plus ras oncogene in the presence of progesterone but not estrogen. Integrated and intact human papillomavirus type 16 deoxyribonucleic acid is present and expressed in all the five progesterone-transformed colonies that we examined. Moreover, all these cell lines are capable of anchorage-independent growth and induce tumors in syngeneic animals. We also observed oncogenic transformation with human papillomavirus type 16 deoxyribonucleic acid plus ras in the presence of ethanol-soluble extracts from two brands of commonly used oral contraceptive tablets. No transformation is achieved in the presence of ethanol-soluble extracts from the inert tablets, provided in packages of each brand of oral contraceptive. These results may have implications for a papillomavirus-hormone link to cervical neoplasia.

Administration, Oral↗
PubMed1980

Levels of HCG in subjects using the Progestasert(TM) intrauterine progesterone systems.

Twelve subjects using the intrauterine progesterone system were followed during 4 consecutive menstrual cycles for FSH, LH, hCG and progesterone levels. They were all multiparous, with documented ovulation and sexually active even during the ovulatory period. With the exception of one case which became pregnant, there was no evidence for the presence of hCG during the period of observation. This data, even if preliminary, suggest that the Progestasert(TM) exerts a contraceptive action which differs from that of other devices, whether medicated or not, and that, such action occurs at a stage early enough to prevent the formation of hCG.

Adult↗
PubMed1980

Further studies on the trichosanthin-induced termination of pregnancy.

Trichosanthin (TCS), a protein from the root extract of Trichosanthis kirilowii, terminated pregnancy when injected once in 15-day pregnant rabbits (2 mg/doe) but failed to interrupt pregnancy in 12-day pregnant rabbits even at higher doses. In vitro release of progesterone (delta 4P) from the maternal or fetal placental tissue into the incubation medium was not affected by TCS. When the distribution of 125I-TCS was traced in 12-day pregnant mice, persistently higher concentration of 125I-radioactivity was detected in the kidney. By contrast, in other organs, including the reproductive organs, blood serum and amniotic fluid 125I-radioactivity declined between 12-48 h after treatment. The low 125I-radioactivity in both the reproductive organs and amniotic fluid suggests a possible barrier between the embryo and maternal blood. It is suggested that TCS might be acting directly on the placental unit, causing fetal death and dislodging of the placenta. Administration of TCS to PD-19 mice or PD-28 rabbits resulted in premature delivery. This effect of TCS in pregnant mice was comparable to the administration of PGF2 alpha.

Abortion, Spontaneous↗
PubMed1981

Studies on ovarian and adrenal steroids at different phases of the menstrual cycle. 1. Dynamic changes during the periovulatory period.

In order to assess the periovulatory interrelationships between the plasma levels of estradiol, estrone, 17-hydroxyprogesterone, progesterone, cortisol and biologically active lutropin (LH), peripheral blood samples withdrawn from 12 normally menstruating women at 07.00, 15.00 and 23.00 h. during seven days of the midcycle period were analyzed. The estradiol peak varied between 0.86 and 1.50 nmol/l; it preceded the LH peak in 11 subjects and occurred simultaneously with it in 1 case. Although the peak levels of estradiol were significantly higher than those associated with the LH peak, there was no significant difference between the estradiol levels at the LH peak and those found during the 32-hour period prior to the LH peak. Calculation of the estradiol to estrone ratios revealed the existence of two groups of subjects with significantly different ratios. In one group the estradiol levels were significantly lower and those of estrone significantly higher than in the other group. No difference was found between these two groups concerning the other hormonal indices measured. No significant variation was found in the estradiol, estrone and LH levels during the day; however, there was a significant overnight increase in their levels during 3 to 4 days preceding the day of the LH peak. A significant rise in 17-hydroxyprogesterone levels occurred 8 h. before the earliest rise in LH and progesterone levels; on the other hand, in none of the subjects did the first rise in progesterone levels precede the first significant elevation of LH levels.

Adrenal Glands↗
PubMed1982

The effect of ethinyl estradiol 20 mcg and levonorgestrel 250 mcg on the pituitary-ovarian function during normal tablet-taking and when tablets are missed.

A new combined pill containing 20 micrograms of ethinyl estradiol and 250 micrograms of levonorgestrel has been developed. The safety margin of this type of low-dose preparation needed to be assessed and this was done by evaluating daily levels of LH, FSH, estradiol, progesterone, 1-NG and EE2 as well as cervical mucus characteristics in six patients when one and then two consecutive pills were deliberately omitted mid-way through the cycle. Results demonstrated that there was no evidence of breakthrough ovulation, although there was some continued ovarian steroidogenesis, a feature consistent with previous studies using combined preparations. Existing instructions to patients regarding missed pills should continue in order to ensure maximal contraceptive safety.

Adolescent↗
PubMed1983

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.

17-alpha-Hydroxyprogesterone↗
PubMed1988

Serum estrogens and ovulation return in chronic users of a once-a-month injectable contraceptive.

To determine whether the long-term exposure to a monthly injectable contraceptive, containing dihydroxyprogesterone acetophenide 150 mg and estradiol enanthate 10 mg, induces significant changes on the serum estrogens profile and ovulation return in women, a study in chronic users was undertaken. Ovarian function was assessed for 3 months following a single injection of the contraceptive agent in a group of women (n = 7) who have been on this formulation for an average period of 6.7 years and in a non-user control group (n = 7). The serum concentrations of 17 beta-estradiol, estrone and progesterone were measured in samples drawn at regular intervals throughout the entire study. The endometrial bleeding pattern was recorded in all subjects. The results indicated that the post-injection serum estradiol maximum levels (exogenous peak) occurred significantly earlier (p less than 0.05) in chronic users as compared with the non-user control group. Baseline serum estrone concentrations were slightly higher in chronic users than those observed in the control group, while the values of serum 17 beta-estradiol did not exhibit significant differences among the two groups. Ovulation was documented within 60-90 days after injection in all subjects from both groups. A similar length of the first bleeding-free period was observed in all participants. The overall data provide evidence of a moderate increase of estrone, one of the still active metabolic conversion products of 17 beta-estradiol, in the sera of chronic users of this combined contraceptive without affecting its pharmacodynamics.

Adult↗
PubMed1991

Effects of mifepristone in vivo on decidual prostaglandin synthesis and metabolism.

Mifepristone is an effective abortifacient in combination with an exogenous prostaglandin but its mechanism of action is unknown. Mifepristone stimulates prostaglandin production from decidua in tissue culture. To determine whether this effect also operates in vivo, we treated women with mifepristone 24, 36 and 48 hours prior to surgical termination. Decidua was removed at operation and the ability of the tissue to generate prostaglandin in culture subsequently assessed. Pretreatment with mifepristone 36 hours prior to termination of pregnancy resulted in an increased production of PGF2 alpha in tissue culture (p less than 0.01). A significant decrease in PGFM production was seen 24 hours after pretreatment with mifepristone in vivo (p less than 0.01). These results suggest that the increased uterine activity observed after administration of mifepristone may be due to stimulation of endogenous prostaglandin production and inhibition of prostaglandin metabolism.

Culture Techniques↗