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Biomedical subjects

V Brache

Publications and source records attributed to V Brache.

At least 73 records · Page 4Linked to original sources
PubMed1987

Subjective perception of bleeding and serum ferritin concentration in long-term users of Norplant.

UNLABELLED: Serum ferritin was measured in 4 groups of long-term users of NORPLANT implants. The users were divided according to their own subjective perception of bleeding: a random sample of 46 one year active users; 30 active users who had increased bleeding; 39 women who had increased bleeding and had the implants removed; 28 active or terminated users who had reduced bleeding. These four groups were compared with a control group of 68 new acceptors of any method at the same clinic who met the criteria for use of NORPLANT. The mean age, parity, years of schooling and family income were similar for the 5 groups. Mean hematocrit for all NORPLANT groups were significantly higher than the control group. About half of the NORPLANT subjects and controls with normal hematocrit had ferritin levels below 11 ng/ml. The proportion of subjects with ferritin less than 11.0 ng/ml were: Group 1) 48%; 2) 63%; 3) 77%; 4) 36% and CONTROLS: 57%. Mean iron stores for all NORPLANT users did not differ significantly from those of a demographically similar control group. Significant differences were, however, observed in two subgroups of NORPLANT users. Those women who had increased bleeding and requested implant removal had lower mean ferritin levels and those who perceived decreased bleeding as a result of NORPLANT use had higher ferritin concentration.

Adult↗
PubMed1986

Recovery of fertility after use of the levonorgestrel 20 mcg/d or Copper T 380 Ag intrauterine device.

Following use of either the Levonorgestrel 20 mcg/day or the TCu 380 Ag IUD in a randomized comparative study, 110 women stopped contracepting to have planned pregnancies. Pregnancy rates and recovery of fertility have been assessed. Age at acceptance, duration of use, parity and intervals between last pregnancy and IUD insertion or removal were similar for both groups. Life table pregnancy rates at one year were higher than 90 per cent for both device groups; but because some women quickly changed their minds or had been at risk of pregnancy only a short time before the analysis date, only 60.9 percent had actually become pregnant. Median time to planned pregnancy was 3 months for the TCu 380 Ag group and 4 months for the Levonorgestrel 20 group. Neither duration of use nor age at insertion or age at termination affected the pregnancy rates significantly.

Adult↗
PubMed1986

Abnormal endocrine profile among women with confirmed or presumed ovulation during long-term Norplant use.

FSH, LH, estradiol and progesterone were serially assayed during 8 cycles of six subjects using six subdermal implants releasing levonorgestrel (NORPLANT) for a period of 2 to 6 years. All 8 cycles studied had a very low LH peak and a low or nonexistent FSH peak as compared to 8 control cycles. The mean LH peak for NORPLANT users was 33.9 mIU/ml as compared to 142 mIU/ml in the control group; and FSH was 13.0 mIU/ml as compared to 31.3 mIU/ml in controls. A subsequent rise in progesterone was observed in the 8 cycles studied, but the mean mid-luteal levels were significantly lower than in controls (9.0 ng/ml vs. 15.6 ng/ml). No differences were observed in the estradiol curve. Two of the subjects using NORPLANT had a laparotomy performed on days 17 and 20 of the cycle, for surgical sterilization purposes. A distinctive corpus luteum with a stigma was observed. Our results indicate that women under prolonged use of NORPLANT do not have normal endocrine cycles, even though they may ovulate. It is doubtful however, that these ovulatory cycles can be fertile under the abnormal endocrine conditions found in our subjects. In addition to the possible effect of luteal insufficiency, the normal maturation of the oocyte may be impaired.

Adult↗
PubMed1985

Contraception with long-acting subdermal implants. A five-year clinical trial with Silastic covered rod implants containing levonorgestrel. The International Committee for Contraception Research (ICCR) of the Population Council.

A total of 189 women volunteered to accept subdermal implants for contraception. The implants were "covered rods", consisting of a core rod containing equal parts by weight of levonorgestrel and polydimethylsiloxane and sealed inside a thin-walled tube of Silastic tubing with medical adhesive. In one study 78 women used 4 3cm rods (study 07) and in the other 111 women used 6 3cm rods. In 5 years of use there were no pregnancies in either group. Terminations because of menstrual problems were twice as frequent among the 4-rod users than among users of the 6 rods. Menstrual pattern analysis is presented for the two rod regimens and compared with the previously reported patterns for the 6-capsule regimen (NORPLANT). Long--term in vivo release rates are also presented.

Adolescent↗
PubMed1985

Anovulation, inadequate luteal phase and poor sperm penetration in cervical mucus during prolonged use of Norplant implants.

Blood samples for progesterone assay were collected for a total of 49 cycles, from 27 volunteers using the NORPLANT system. Levonorgestrel determinations were carried out in the same samples. A group of 12 women with normal cycles were studied in the same manner to serve as controls. Of the 49 cycles studied, 20 (41%) were ovulatory. The mean levonorgestrel level in ovulatory patients was 0.34 +/- 0.11 ng/ml (S.D.) compared to 0.42 +/- 0.14 ng/ml (S.D.) in anovulatory cycles. Compared to the control group, progesterone levels were significantly lower for users of NORPLANT implants during days -12 to -10 (p less than 0.025), -9 to -7 (p less than 0.05), -6 to -4 (p less than 0.0005) and days -3 to -1 (p less than 0.01). Cervical mucus evaluations and post-coital tests were done around mid-cycle in 29 of the cycles studied. All samples of cervical mucus were of poor quality, viscous and scarce, with a mean SPK of 4.1 +/- 2.3 cm. Most had absent or atypical ferning. Twenty-one subjects (73%) had a post-coital score of 1, and 4 (14%) of zero. Thus, anovulation, inadequate luteal phase and the direct effect of the continuous administration of levonorgestrel over cervical function, all seem to contribute to the effectiveness of NORPLANT implants.

Anovulation↗
PubMed1984

Intrauterine contraception with copper and with levonorgestrel: a randomized study of the TCu 380Ag and levonorgestrel 20 mcg/day devices.

First year results of a randomized study of 1509 users of the Copper T380Ag with a silver core or of an IUD releasing 20 mcg day of levonorgestrel are reported. The cumulative gross pregnancy rate for each device was 0.3 per 100 at one year, with more than 490 women having one year of use with each device. The levonorgestrel-releasing device was associated with significantly fewer bleeding days and significantly increased hemoglobin levels when compared with pre-admission values or the one year values observed among users of the TCu380Ag. Terminations attributable to amenorrhea were significantly more frequent among users of the levonorgestrel-releasing device. The TCu 380Ag was associated with increased frequency and severity of dysmenorrhea compared with pre-admission levels or with the steroid-releasing device. Hemoglobin levels were somewhat reduced among users of the TCu 380Ag device. Terminations attributable to pain were, however, not significantly different by device. Continuation rates at the end of the first year were not significantly different by device.

Adolescent↗
PubMed1983

Levonorgestrel plasma levels during continuous administration with different models of subdermal implants.

Plasma concentrations of levonorgestrel were determined in women using subdermal levonorgestrel implants. One group had 6 Silastic capsules (NORPLANT), one group had 4 and one group had 6 covered Silastic rods for variable lengths of time. Levonorgestrel concentrations remained constant around 0.4 ng/ml up until 6 years of use in the Norplant group. The observation period was shorter for the covered rods; plasma concentrations were, however, constant around 0.55 ng/ml and 0.70 ng/ml for 3.5 years with the 4 rods and 6 covered rods, respectively. The difference in mean levonorgestrel concentrations between the three groups were statistically significant (p less than 0.0005). Plasma levels of levonorgestrel were twice to three times higher in blood obtained from the arm with the implants compared to the levels found in the other arm. The application of a tourniquet for variable periods before blood sampling did not influence the plasma concentrations of levonorgestrel.

Blood Specimen Collection↗
PubMed1982

The effect of levonorgestrel and estrone rods on male reproductive function.

The effect on spermatogenesis of the implantation of six rods containing levonorgestrel and three estrone rods was studied in seven volunteers aged 32-40, with normal pre-treatment spermiogram. None of the subjects achieved azoospermia. The lowest sperm count was below 1 million/ml in three subjects and below 12 million/ml in the other four. Plasma FSH and testosterone were severely depressed during the study, but LH was only transiently depressed for the first two months. Four subjects recovered pre-treatment sperm counts in spite of the FSH levels below 1.5 mIU/ml and testosterone levels below 1 ng/ml, which is contradictory to the current concept on hormonal regulation of spermatogenesis.

Adult↗
PubMed1981

A multicenter study of levonorgestrel-estradiol contraceptive vaginal rings. II-Subjective and objective measures of effects. An international comparative trial.

Comparative clinical trials of 2 sizes of contraceptive vaginal rings and of an oral contraceptive were undertaken at 8 investigational sites (9 clinics). More than 500 women enrolled on each of the 3 study regimens. Side effects of the rings and of Nordette, the oral contraceptive, were evaluated by noting spontaneous complaints, by recording medications taken and by physical examination. Inquiries about changes in the frequency of specific conditions were made at the end of the subjects participation in the first year of the study. The incidence of spontaneous complaints was similar among users of the 2 different-sized rings and of the pill.

Adolescent↗
PubMed1981

A multicenter study of levonorgestrel-estradiol contraceptive vaginal rings. III-Menstrual patterns. An international comparative trial.

Menstrual events among users of contraceptive vaginal rings (CVRs), releasing levonorgestrel and estradiol, were studied in comparison with a combined oral contraceptive, Nordette, in multicentered trials. CVRs were made with outside diameters of 50 and 58 mm and released about 250 micrograms and 290 microgram of levonorgestrel and 150 microgram and 180 microgram of estradiol per day, respectively. The CVRs were used continuously for 3 weeks and then removed for 1 week. Both the CVRs and Nordette were perceived to reduce menstrual flow and days of menstrual bleeding. Twenty to 25% of CVR users perceived increased intermenstrual bleeding or spotting. Diaries indicate, however, that on average, CVR users experienced about 1 day per month of bleeding or spotting with the ring in place. CVRs and Nordette produced approximately the same total number of bleeding and spotting days during 6 cycles of use, 27-29, but the small (50-mm OD) ring was associated with somewhat more spotting. This ring was also associated with somewhat more prolonged bleeding and spotting runs and with more prolonged nonbleeding intervals than reported by users of the larger (58-mm OD) ring or of Nordette. Differences among regimens, however, tended to be small even when statistically significant. Evidence from menstrual diaries indicates that these CVRs, and in particular 58-mm ring, provide control over the menstrual cycle comparable to the Nordette.

Adolescent↗
PubMed1981

Lipoprotein patterns in women in Santo Domingo using a levonorgestrel/estradiol contraceptive ring.

Ten healthy, normally menstruating women attending a family planning clinic in Santo Domingo Participated in a study to determine the effects on plasma lipid levels of levonorgestrel and estradiol released from a contraceptive ring. A schedule of 21 days of use followed by 7 days of non-use was followed for 6 cycles. During the first two cycles of use, concentrations of cholesterol, HDL cholesterol, triglycerides and LDL cholesterol declined significantly from control levels, up to 25% for cholesterol, 28% for HDL cholesterol, 45% for friglycerides and 24% for LDL cholesterol. There were no subsequent changes with continued use. These declines are similar in direction but of lesser magnitude than those reported from clinics in other countries where pretreatment plasma levels of the same lipids are considerably higher. There was no significant change in the total cholesterol to HDL cholesterol ratio during treatment.

Adolescent↗
PubMed1981

Sperm migration at different stages of the menstrual cycle.

Sperm migration to the upper genital tract was studied in 15 volunteers who were to be surgically sterilized to see if sperm migration to the upper genital tract is consistent during different stages of the menstrual cycle. Five subjects underwent surgery during the midproliferative phase, five during the periovulatory period and five during the secretory phase. The stage of the cycle was determined by endometrial and ovarian biopsy at the time of surgery. Volunteers had a single coitus 5-12 h before surgery, confirmed by Sims-Huhner test. Sperm were found in the uterus and at least one oviduct in all five subjects studied during the periovulatory phase, and only in two of the five cases undergoing surgery during either of the other phases. A good correlation was also observed between presence and number of sperm in the upper genital tract and quality of Sims-Huhner test. However, neither the cycle stage nor the postcoital test had an absolute prognostic value over sperm migration.

Adult↗
PubMed1981

Pituitary-ovarian function after tubal ligation.

Pituitary-ovarian function was evaluated by measurement of daily serum levels of luteinizing hormone (LH), 17 beta-estradiol, and progesterone in women with a previous history of tubal ligation. Normally menstruating women served as controls. The duration of the proliferative and luteal phase was similar for both groups. The midluteal progesterone level averages did not differ between the two groups. Preovulatory LH and 17 beta-estradiol peaks were significantly lower in the tubal ligation group; average midluteal LH and 17 beta-estradiol levels were also lower. These results reveal that pituitary-ovarian function can be altered following surgical sterilization.

Adult↗
PubMed1981

Sperm suppression with monthly injections of medroxyprogesterone acetate combined with testosterone enanthate at a high dose (500 mg).

The combination of an initial injection of 1000 mg of depot medroxyprogesterone acetate and 500 mg of testosterone enanthate, followed by monthly administration of 150 mg and 500 mg of the same drugs, was tested in 10 healthy males aged 28 through 39, with pre-treatment sperm counts of 50 x 10(6)/ml or more. Eight of the subjects achieved azoospermia, and the sperm counts of the other two declined 0.09 ad 5 million/ml. This last subject was highly refractory to treatment as his sperm density recovered to 27 million sperm/ml at the 6th month of continuous therapy. FSH was severely depressed during the entire treatment period. LH fell to 30--40% of normal values in the first two months and then showed a slow recovery during maintenance treatment. Testosterone measured one month after each injection was between 10 and 30% of pre-treatment values. Three of the subjects had increased libido and potency, none had decreased sexual drive or potency. All subjects gained weight with the average gain being 6 kg. The increase in the dose of testosterone enanthate to 500 mg/ng did not improve the results as compared to previous trials using lower doses of TE.

Adult↗
PubMed1980

The menstrual cycle in women using an intrauterine device.

The duration and hormonal characteristics of the menstrual cycles of women using Copper T intrauterine devices (IUDs) were studied. Daily load samples were obtained during both the pre- and postovulatory phases of 30 IUD-associated cycles and the hormone values were compared with those of 15 normally menstruating women not using contraception. The ovulation rate and peak levels of 17 beta-estradiol and luteinizing hormone (LH) were not significantly different between the two groups. The average number of days from the 1st day of menstrual bleeding to the LH peak (the proliferative phase) was longer in the IUD users. The number of days from the LH peak to the onset of menstrual bleeding (the luteal phase) was shorter in the IUD users. Because of the compensating nature of these statistically significant differences, the total cycle length appeared to be unchanged. At the time of menstruation, the plasma levels of both progesterone and 17 beta-estradiol were significantly higher among IUD users. It is concluded that the presence of an IUD does not influence ovarian function, but that ovarian steroid production and endometrial events become asynchronous.

Adolescent↗
PubMed1979

Pregnancies associated with sperm concentrations below 10 million/ml in clinical studies of a potential male contraceptive method, monthly depot medroxyprogesterone acetate and testosterone esters.

A potential male contraceptive approach was evaluated in clinical trials involving monthly injections of depot medroxyprogesterone acetate and either subdermal implants of testosterone propionate or monthly injections of testosterone enanthate. Pregnancies occurred in partners of 9 men with recent sperm counts of 10 million/ml or below. In 5 of the 9 instances, the sperm counts were less than 1 million/ml. It appears that male contraceptive methods involving spermatogenic suppression may require attainment and maintenance of azoospermia. The pregnancy rate cannot be calculated, because the extent of other contraceptive use is uncertain. There were no spontaneous abortions. 6 pregnancies were carried to term, and all progeny were normal, based on physical examination at birth or 3 months after birth.

Contraceptive Agents, Male↗