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PubMed1978

Clinical experience with implant contraception.

Subdermal implants of polysiloxane (Silastic) capsules containing a number of synthetic progestagens have been studied in clinical trials to determine their contraceptive effectiveness and acceptability. The steroids studied include norgestrienone (R2010), gestrigone (R2323), megestrol acetate, d-norgestrel, norethindrone, ST-1435, lynestrenol and R-1364. With some of these steroids, studies have been undertaken with a varying number of implanted capsules. The estimated duration of use varies from 6 months to 6 years depending on dose and release rate of the individual steroid. The results of these studies involving about 5000 women in 8 years, indicate in general a high rate of effectiveness, as well as acceptability. Continuation rates at one year were generally 80% or greater. Abnormal bleeding patterns are the major disadvantage. Studies with implatns containing a combination of estrogen and progestogen are being undertaken in an attempt to improve the bleeding pattern.

Contraceptive Agents, Female↗
PubMed1977

Ultrastructural stereology: a new approach to the study of prostatic function.

Stereology is a method used to obtain quantitative information of structural changes at the light and electron microscopic level. The basic principles of stereology are outlined below. This paper shows how stereologic techniques can be used to obtain structural data from histologic and electron micrographs of intact tissue and cells. A morphometric model, which provides information on the structure of the prostatic gland has been developed for the rat prostate. The model consists of morphologically defined space and membrane compartments of the prostatic gland and the glandular cells. The alterations, induced in the glandular cells of the ventral lobe of rat prostate by the administration of a synthetic progestin (ethinyl-norgestrienone), were studied by electron microscopy. The results presented are relative to a cubic centimeter of prostatic tissue, a cubic centimeter of acinar parenchyma, and glandular cell cytoplasm. An attempt to relate stereologic and biochemical data is shown.

Animals↗
PubMed1980

Silastic implants releasing estrone in the treatment of climacteric complaints.

A study on continuous low-dose estrone treatment achieved with two different silastic implants is presented. In the study estrogen treatment was supplemented with the addition of progestin in three different modes of application. The measurements of plasma estrone and estradiol concentration showed a 3- to 6-fold and a 2- to 3-fold increase, and that of FSH a decrease of 25%. The measurements of plasma estrone gave concentrations of 200-400 pg/ml and plasma estradiol was 70-200 pg/ml with uncovered estrone-releasing implants after 4 wk of treatment. The ratio of plasma levels of estrone/estradiol was around 3. The initial high estrone concentration after implantation could be eliminated by covering the rods with a thin layer of neutral silastic material. Plasma FSH and LH concentration significantly depressed when the estrone treatment was combined with levonorgestrel-releasing implants. The insertion of estrone-releasing implants alone and in combination with the cyclic treatment with norethindrone perorally, or with a norgestrienone-releasing silastic vaginal ring suppressed only the plasma FSH concentration. The climacteric complaints disappeared in a few days in every patient treated with uncovered estrone-releasing implants. Because it is easy to remove when required, the treatment with estrone-releasing silastic implants can be regarded as being safe for the patients.

Climacteric↗
PubMed1980

Ectopic pregnancies associated with low dose progestagen-releasing IUDs.

Dimethyl-polysiloxane capsules containing pure progestagens were attached to Tatum's T IUDs and tested in 594 fertile women for contraceptive performance. The control group was represented by 71 women who received identical devices containing barium sulphate instead of steroid and 100 women who received a Copper T-200. The progestagens and the doses tested were megestrol acetate (4.8, 19.2, 26 and 32 micrograms/day; levonorgestrel (2.1, 3.4 and 8.5 micrograms/day); norethindrone (18 micrograms/day); R2323 (28.6 and 45 micrograms/day); and norgestrienone (26 micrograms/day). Twelve pregnancies were diagnosed during 5201 woman-months of exposure accumulated within the first year of use among users of the steroid-bearing IUDs. Five of these were ectopic gestations. Ten pregnancies, all uterine, were detected during 1701 woman-months of exposure in the control group. Intrauterine delivery of progestagens by means of a carrier IUD is effective in decreasing the pregnancy rate but it might effect postovulatory events in a way which increases the rate of tubal implantation. Because of this property, progestagen-releasing IUDs should be limited to doses that assure maximal effectiveness to avoid increasing the risk of ectopic pregnancy.

Adolescent↗
PubMed1977

Stereology, a new quantitative morphological approach to study prostatic function and disease.

Although a considerable amount of quantitative biochemical data of the prostatic gland is available the current morphological information is restricted up to now to descriptive findings. Stereology is the application of mathematical axioms and allows one to quantitate three-dimensional structures from the measurement of two-dimensional cross sections thereof. The stereological techniques provide values for volumes, surfaces and number of tissue and glandular cellular components found within the prostatic gland. Four examples are presented to illustrate how quantitative morphology can be applied to study prostatic function and disease. A stereological model, which provides information on the structure of the prostatic gland is shown for the rat prostate (ventral lobe). The model consists of morphologically defined space and membrane components of the prostatic gland and the glandular cell. The alteration, induced in the glandular cells of the ventral lobe of the rat prostate by administration of a synthetic progestine (ethinyl-norgestrienone) were studied by stereological methods. An attempt was made to quantify the morphological aspects of both, the epithelial and stromal components of the normal human prostate (3rd decade of life) and of benign prostatic hyperplasia. In comparing the stereological data of the glandular prostatic cell in the normal human prostate with that in benign prostatic hyperplasia, a diminished secretory activity of the glandular cell in benign prostatic hyperplasia is indicated. A high volume density of the fibromuscular tissue, as well as an activation of the smooth muscle cell in the fibromuscular tissue is observed in benign prostatic hyperplasia.

Adult↗
PubMed1975

[Radioimmunoassay of synthetic steroids].

The sensitivity of a radioimmunoassay depends on the intrinsic association constant of the interaction between ligand and antibody. Its specificity depends on the position of the chain which forms the link with the antigen. Thus, an antibody specific of estradiol has been obtained by coupling estradiol to albumin via a chain at position 7. For synthetic steroids the structure of which is sufficiency different from that of natural hormones, the requirements for a sensitive assay method not involving chromatography are simply maximum affinity and positioning of the couple at a site which does not undergo metabolic attack. These criteria were used to develop assays for R 2858 and R 2453 which obviate the need to administer radioactive product in clinical pharmacology. Cross-reaction with structural analogs may be used to assay competitors. Thus, R 2323 antibody, highly specific for endogenous steroids, may be used to assay other trienes such as R 1697 (trenbolone) and R 2010 (norgestrienone).

Antibody Specificity↗
PubMedDate not supplied

[Contraception and endometriosis].

Contraception in women with endometriosis is unusual. In case of mild asymptomatic endometriosis all contraceptive methods may be used except predominant estrogenic action pills. In case of severe endometriosis if score is upon 70 or adhesion score upon 50 the patients are generally infertile. Contraception is not necessary. If scores are lower, medical treatment of endometriosis insure the contraception during the first six months. Afterwards an hydroxyprogesterone derivative pill such as cyproterone acetate, or a norpregnan derivative pill, or a combined estrogen progestogen pill, with predominant progestogen action (norgestrienon), or a monophasic pill containing norethisteron, or in case of metabolic diseases a pill containing gestoden, must be prescribed three out of four weeks. In case of adenomyosis, vaginal contraception is better. Perhaps in the next future, the new progestogen sterilant will be the best.

Contraception↗
PubMed1976

Action of midcycle contraceptive (R 2323) on the human endometrium.

Over 2,148 cycles of midcycle oral administration of R 2323 (50 mg. per day on Days 15,16, and 17), the authors recorded a drug-failure pregnancy rate of 5 per cent and an unusually regular cycle length of 28 +/- 2 days. During this trial, endometrial biopsies obtained in the luteal phase were examined by light and electron microscopy and compared to pretreatment biopsies. Light microscopy indicated a weakly secretory endometrium suggestive of some, albeit low, progesterone impregnation. Ultrastructural examination revealed deleterious changes in the development of the nucleolar channel system and giant mitochondria and a delay in the migration of glycogen granules. This low progesterone impregnation could be explained either by a direct effect of R 2323 on cell ultrastructure or by interference with progesterone availability. It would appear that R 2323 acts as a temporary substitute for progesterone at the receptor level but that it does not induce all the biological manifestations of this hormone, in particular, the endometrial changes required for implantation.

Biopsy↗
PubMed1980

A study of interaction of a low-dose combination oral contraceptive with anti-tubercular drugs.

Low-dose combination contraceptive (containing norethisterone acetate 1 mg and ethinyl estradiol 30 micrograms) was administered to women receiving concurrent therapy with either Rifampicin or "triple" antitubercular treatment consisting of paraaminosalicylic acid (PAS), isonicotinic acid hydrazide (INH) and streptomycin. Plasma levels of norethisterone (NET) and ethinyl estradiol (EE), PAS and INH were measured and the area under curve (AUC) was calculated for NET and EE. Rifampicin treatment (9 women) caused a statistically significant reduction of the plasma NET levels as well as the AUC of NET. In this group of women, though a trend for reduction in EE levels was observed in individual subjects, it was not statistically significant. Out of 7 regularly menstruating women on Rifampicin therapy, 2 showed a premenstrual rise of plasma progesterone (P) levels (> 4 ng/ml) suggesting an ovulatory cycle and 3 experienced menstrual irregularities. In contrast, plasma levels of NET and EE as well as their AUCs were not altered in 8 women receiving "triple" antitubercular therapy. Only one woman out of 8, had menstrual irregularity and all women had P levels in the anovulatory range. Furthermore, oral contraceptive treatment did not alter the plasma levels of PAS and INH.

Adult↗