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At least 1,243 records · Page 69Linked to original sources
PubMed1990

A comparative study of the safety, effectiveness and acceptability of two foaming vaginal tablets (nonoxynol-9 versus menfegol) in Thai women.

Two foaming vaginal tablets containing nonoxynol-9 (OVT-n) or menfegol (OVT-m) were studied to evaluate safety, effectiveness and acceptability. The study was conducted at the Chulalongkorn University, Institute of Health Research, Bangkok, Thailand. One-hundred-two women randomly assigned to one of the two types of tablets were scheduled for follow-up visits at 1, 3, 6 and 12 months. Although there were differences between the two groups in the gross cumulative 12-month life table rates and 12-month continuation rates, these differences were not statistically significant. Twelve-month discontinuation rates for accidental pregnancy were 31.7 per 100 women for OVT-n group and 25.3 per 100 women for the OVT-m group. Seventeen of the total 22 pregnancies occurred due to use failure. This study indicates that the regular and proper use of OVT-n or OVT-m tablets are comparable and are a safe means of birth control. Although a few product-related (burning) or medical complaints were reported by both groups of tablet users, it seems that the vaginal contraceptive is an acceptable method for fertility control in a suitable population who will use it regularly and properly.

Administration, Intravaginal↗
PubMed1991

Quantitative analysis of nonoxynol-9 in blood.

At present, there is little data on the level of nonoxynol-9 (N-9) in blood. Using routine methods, the rate of recovery for N-9 in blood has been confirmed to be very low. A method determining N-9 levels in urine has been found but obviously a more efficient method for determining N-9 levels in blood and urine is still needed. Here, a method of determining N-9, a nonionic surfactant spermicide, in blood is presented. The analytical procedure is a simple and convenient method. Using HPLC, UV detector, ODS reversed-phase column, methanol-water mobile phase, NaCl salting-out and two extractions with benzene, a rate of recovery for N-9 of 93 +/- 4% has been obtained.

Administration, Intravaginal↗
PubMed1992

Ovarian activity and bleeding patterns during extended continuous use of a combined contraceptive vaginal ring.

A combined contraceptive vaginal ring with a mean release rate of 0.015 mg of ethinyloestradiol and 0.120 mg of 3-ketodesogestrel per day was used by female volunteers, for either 28, 42, 56 or 84 days. Contraceptive efficacy was assessed by pelvic ultrasound scanning, endocrine monitoring and cervical mucus assessment. Menstrual diary cards were analysed to assess the effect on cycle control. Ovulation inhibition was seen in all treatment groups. Following removal of the ring, a return to an ovulatory cycle was observed in all volunteers. With extension of the treatment cycle beyond the recommended 21 days, there is an increase in the occurrence of bleeding and spotting episodes. This can be compared to patterns obtained during continuous use of combined oral contraceptives.

Administration, Intravaginal↗
PubMed1992

Progesterone-releasing vaginal rings for use in postpartum contraception. II. Pharmacokinetic profiles in women.

Vaginal rings releasing progesterone with 3 different initial release rates (5, 8 and 20 mg/day) were used by 11, 10 and 10 women, respectively. The period of insertion was 90 days. The 5 and 8 mg/day rings consisted of a core loaded with progesterone, the 20 mg/day ring contained progesterone homogeneously distributed throughout the mass of the ring. Notwithstanding these differences, the total progesterone levels (areas under curve) were directly related to the release rates. So were the rates of decrease of progesterone levels during the 90 days of insertion of the ring. They were 25, 31 and 47% for the rings releasing 5, 8 and 20 mg/day, respectively.

Administration, Intravaginal↗
PubMed1992

Microbiological studies in mid-trimester abortion with Emcredil versus normal saline.

In 40 mid-trimester abortion seekers, in whom abortion was induced by extra-amniotic normal saline or Emcredil, microbiological studies were carried out before induction and at 24 hours. It was observed that there was no difference in the isolation of organisms from vagina and cervix of these subjects between 0 hours and 24 hours. Thus, this study shows that leaving the catheter in the extra-amniotic space until it is expelled spontaneously does not increase the risk of ascending infection. At the same time, leaving the catheter in-situ until it is expelled spontaneously reduces the induction-abortion interval appreciably.

Abortion, Induced↗
PubMed1992

Evaluation of four different contraceptive vaginal rings: steroid serum levels, luteal activity, bleeding control and lipid profiles.

Four different models of contraceptive vaginal rings were tested during three cycles for luteal activity, bleeding control, plasma lipoproteins and serum levels of the contraceptive steroids. Two progestins, levonorgestrel acetate (LNGA) and ST 1435, alone or in combination with ethynyl-estradiol (EE) were tested. The rings released 100 ug/day of the progestins and 30 ug/day of EE. Luteal activity was detected among users of the progestin-only rings: 4 of 8 cycles with ST 1435 and 2 of 10 with LNGA. Only one of the 18 cycles studied with the two combined rings showed luteal activity, but the measurement of contraceptive steroid in plasma suggested that this subject delayed reinsertion of the ring for about one week in that particular cycle. Breakthrough bleeding was observed in 12 of 30 cycles of use of the progestin-only rings, and in only 2 of 27 cycles with the combined models. No significant changes in total cholesterol or its HDL-fraction were observed. However, the only reduction observed in HDL-cholesterol was among users of the LNGA-only ring. It is concluded that the two combined CVR models offer good possibilities of high effectiveness and bleeding control and merit further development.

Administration, Intravaginal↗
PubMed1992

The effects of a combined contraceptive vaginal ring releasing ethinyloestradiol and 3-ketodesogestrel on vaginal flora.

Fifty nine women with documented normal ovulatory cycles and with no symptoms of vaginal infection were divided into four groups. Each group used a combined contraceptive vaginal ring (CCVR) with a mean daily release rate of 0.015 mg of ethinyloestradiol (EE) and 0.120 mg of 3-ketodesogestrel (3-KDG) per day, for one cycle of either 21, 28, 42, or 56 days. Cultures from the posterior vaginal fornix and from the endocervical canal were obtained immediately before insertion of the ring and on removal of the ring. Changes in the numbers of vaginal cells, aerobic and anaerobic bacteria, Chlamydia trachomatis, Gardnerella vaginalis, yeasts and Trichomonas vaginalis were documented at the end of each treatment. Intra- and inter- group changes in the vaginal flora were assessed at the end of each treatment. The comparison between the number and type of flora showed no significant change between the pre-treatment population and the post-treatment population. The results of this study suggest that the use of this CCVR for 21, 28, 42 and 56 days is not associated with an increase in inflammatory cells or pathogenic bacteria.

Administration, Intravaginal↗
PubMed1994

A contraceptive vaginal ring releasing norethindrone acetate and ethinyl estradiol.

A core design contraceptive vaginal ring (CVR) releasing 650 mcg of norethindrone acetate (NA) and 10, 20, 30 or 65 mcg of ethinyl estradiol (EE) daily was developed and tested in 99 women. The CVR inhibited ovulation well with 30 or 65 mcg EE. Vaginal bleeding was better controlled than in 23 control women using NA/EE oral contraceptives. Side effects were comparable to controls for the 20 and 30 mcg EE CVR. The 65 mcg EE CVR resulted in an unacceptably high level of nausea. The 20 and 30 mcg EE CVR caused an increase in serum HDL cholesterol and triglycerides. Total cholesterol was unchanged. Angiotensinogen and sex hormone binding globulin-binding capacity were increased in a subgroup of the 20 and 30 mcg EE CVR subjects, similar to that of 20 controls using EE/gestodene oral contraceptives. This new CVR offers an excellent contraceptive alternative with the best performance provided by the 30 mcg EE dose.

Administration, Intravaginal↗
PubMed1994

Dose-finding study of a contraceptive ring releasing norethindrone acetate/ethinyl estradiol.

A core design contraceptive vaginal ring (CVR) with average daily release of 650 mcg of norethindrone acetate (NA) and 30 mcg of ethinyl estradiol (EE) inhibited ovulation and controlled vaginal bleeding well, but caused some nausea. This study was designed to minimally alter the dose of steroid to see if nausea could be reduced without loss of contraceptive efficacy. This 30/650 CVR was compared to a CVR releasing 20 mcg of EE and 1000 mcg of NA (20/1000) and another releasing 25 mcg of EE and 650 mcg of NA (25/650) in 69 subjects. Twenty-three subjects using an oral contraceptive containing NA/EE served as controls. Ovulation inhibition was excellent and comparable to the OC for all formulations. The CVR provided better control of vaginal bleeding than did the OC. Side effects were equivalent to the OC with the exception of a slight increase in nausea in CVR users. Lipid changes and globulin increases were comparable to oral contraceptive users. The 20/1000 CVR increased sex hormone binding globulin-binding capacity less than the other two CVRs. The performance of the three CVRs was not significantly different, but the 25/650 showed a trend of reduced performance relative to the other two formulations.

Administration, Intravaginal↗
PubMed1994

Studies on a vaginal ring releasing levonorgestrel at an initial rate of 27 micrograms/24 h when used alone or in combination with transdermal systems releasing estradiol.

Vaginal rings releasing levonorgestrel (L-NOG) at an initial rate of 27 micrograms/24h were studied in a group of 24 normally menstruating women during three months (i.e., during three four-week segments). Each segment consisted of three weeks with the vaginal rings in situ followed by a treatment-free period of one week. The women were divided into three groups (8 subjects each). The first group received vaginal rings only, the second and third groups were treated, in addition, with transdermal systems (patches) releasing estradiol at a rate of 50 and 100 micrograms/24h, respectively. Peripheral blood samples were withdrawn three times weekly (Monday, Wednesday and Friday) during a pretreatment cycle and during the following three months of treatment. The levels of L-NOG, estradiol and progesterone were analyzed by radioimmunoassay techniques. In all subjects, endometrial biopsies were taken in a control cycle and during the last days with vaginal rings in situ in segments II and III. The treatment with estradiol did not significantly influence L-NOG levels. Considerable differences in the L-NOG levels between the subjects of the same group were observed. Fluctuation in ovarian reaction within groups was also large. Nevertheless, estradiol noticeably increased the proportion of anovulatory cycles; the total number of anovulatory segments was 5, 9 and 19 (out of 24) in the groups "No estradiol", "50 micrograms/24h estradiol" and "100 micrograms/24h estradiol", respectively. A morphometric study of the endometrium indicated a significant decrease in the diameter of glands. This change was due to L-NOG alone, but it seemed to be accentuated by the exogenous estradiol. The occurrence of glandular mitoses increased in both groups receiving estradiol in a dose-dependent manner, indicating an increased endometrial proliferation. The treatment with estradiol did not significantly alter the bleeding pattern.

Administration, Cutaneous↗
PubMed1994

Pharmacokinetic and pharmacodynamic effects of vaginal rings releasing levonorgestrel at a rate of 27 micrograms/24 hours: a pilot study.

The pharmacokinetic and pharmacodynamic effects of vaginal rings releasing levonorgestrel (L-NOG) at an initial rate of 27 micrograms/24 h were studied in a group of 12 normally menstruating women during 90 days of continuous use (i.e., during three 30-day treatment segments). Blood samples were drawn immediately before insertion, 15 and 30 min, as well as 1, 2, 4, 8, 12 and 24 h after insertion of the rings, and thereafter three times weekly throughout the study for the analysis of L-NOG, estradiol, progesterone and sex hormone-binding globulin (SHBG). Endometrial biopsies were obtained for a morphometric analysis in a pre-treatment (control) cycle and in the 6th and 10th weeks of treatment. The peak of average L-NOG levels was reached within two hours after the insertion of rings. Until 24 h after insertion, the levels did not change significantly. Thereafter, a decrease at a rate of 0.2% per day was initiated. The L-NOG and SHBG levels were highly correlated. This was seen for both the pre-treatment SHBG vs L-NOG (r = 0.96) and the treatment SHBG vs L-NOG levels (r = 0.92). There was a significant (p < 0.001) decrease of SHBG levels due to treatment. During the total of 36 treatment segments, a normal ovarian function was seen in 47% of the segments. The women were anovulatory and had an inadequate lutal function in 28% and 25% of segments, respectively. No correlation between the L-NOG levels and ovarian reaction to treatment was found. The use of L-NOG induced significant changes in the endometrium; the number of glands/mm2 decreased after 6 (p < 0.02) and 10 weeks of use (p < 0.01). Also, the diameter of glands and the occurrence of vacuolated cells decreased significantly (p < 0.02 and p < 0.005, respectively). None of the endometrial parameters or dating was correlated with the ovarian reaction to treatment, indicating independent endometrial effects of L-NOG.

Absorption↗
PubMed1995

The effect of small doses of progesterone released from two types of vaginal rings on ovarian activity and bleeding patterns during the first postpartum year.

A total of 20 breastfeeding women used progesterone-releasing vaginal rings for up to 12 months. The women were divided into two groups, one (n = 9) using rings with an initial release rate of 5 mg/24 h, the other (n = 11) with a release rate of 20 mg/24 h. Individual women started to give breast milk supplements and ceased to breastfeed after various periods of time. Urinary estrone and pregnanediol glucuronide levels were measured by radioimmunoassay three times weekly during the entire trial. Individual diary cards were used to register bleeding and spotting. A significantly higher concentration of pregnanediol glucuronide was seen when the 20 mg/24 h ring was used in the lactation period, in comparison with the 5 mg/24 h ring. In the post-lactation period, pregnanediol glucuronide levels dropped when the 20 mg/24 h ring was used. Estrone glucuronide levels increased after the termination of breastfeeding, indicating an enhanced suppression of ovarian activity in the lactation period with both rings. Although the degree of suppression was dose-related, both rings were likely to offer a sufficient contraceptive effect in the lactation period. No significant changes were observed when milk supplements were added to breastfeeding. The use of the 20 mg/24 h ring resulted in a much better bleeding pattern (significantly less bleeding days) than the 5 mg/24 h ring during the lactation period. In the post-lactation period, the 20 mg/24 h ring the bleeding because much worse than in the lactation period.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed1995

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route.

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

Administration, Intravaginal↗
PubMed1996

Zinc acetate and lyophilized aloe barbadensis as vaginal contraceptive.

Twenty samples of fresh ejaculate, donated by healthy volunteers ranging in age from 20-30 years, were obtained from the Center for Fertility & Cryobiology, University of Missouri, Columbia, Missouri. Average semen volume was 2.49 ml; average sperm motility was 71.32%; and average sperm density was 113.71 x 10(6) /ml. Testing for spermicidal effectiveness of a 1% concentration of zinc acetate, zinc sulfate, zinc chloride, and zinc gluconate proved that only zinc acetate was spermicidal. It appears this is due to the acetate in zinc acetate which may decrease oxygen utilization by sperm. Zinc acetate in vitro was antiviral while lyophilized aloe barbadensis was not. Lyophilized aloe barbadensis at concentrations of 7.5% and 10% proved to be spermicidal due to the multiple micro elements (boron, barium, calcium, chromium, copper, iron, potassium, magnesium, manganese, phosphorus, and zinc) which were toxic to the tail causing instant immobilization. The two compounds did not irritate or cause ulceration of rabbit vaginal epithelium. These results suggest the possibility of using zinc acetate and lyophilized aloe barbadensis as a new, effective and safe vaginal contraceptive.

Acetates↗
PubMed1996

Evaluation of the effectiveness of vaginal misoprostol to induce first trimester abortion.

Two doses, 200 and 400 micrograms, of misoprostol, administered vaginally every 12 hours, up to four times, were tested in 101 and 133 healthy women, respectively, for interruption of pregnancies with 35 through 77 days of amenorrhea. The proportion of women who aborted increased with longer duration of treatment and was significantly higher with 400 than with 200 micrograms (66 versus 46 percent at 48 hours). Significance was maintained after controlling by age, body weight, parity, previous abortion and gestational age. Abortions were classified as incomplete or complete, according to the presence or not of embryonic tissue in the uterine cavity, diagnosed by vaginal sonography. Vacuum aspiration was carried out in all cases not classified as complete abortion 48 hours after the initiation of treatment, or earlier in case of persistent bleeding or woman's request. The possibility of increasing effectiveness by using higher dose, shorter intervals or longer duration of treatment is discussed.

Abortifacient Agents, Nonsteroidal↗
PubMed1996

Methotrexate and misoprostol for early abortion: a multicenter trial. I. Safety and efficacy.

A prospective trial was conducted including 300 pregnant women seeking elective abortion to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at < or = 56 days gestation. Subjects received methotrexate 50 mg/ m2 intramuscularly followed 7 days later by misoprostol 800 micrograms vaginally. The misoprostol dose was repeated the next day if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), duration of vaginal bleeding, and side effects. Complete abortion occurred in 263/ 300 (87.7%, 95% CI 83.4, 91.2%) patients. The complete abortion rate was higher for early gestations: 183/202 (90.6%, 95% CI 85.7, 94.2%) at < or = 49 days gestation, and 80/98 (81.6%, 95% CI 72.5, 88.7%) from 50-56 days gestation (p = 0.038). Abortion occurred in the 24 hours following the initial or repeat misoprostol dose (immediate success) in 65.0%; the remaining 22.7% of women who aborted did so after a delay of 23.6 +/- 9.1 (mean +/- standard deviation) days. Vaginal bleeding lasted 14 +/- 7 days and 11 +/- 9 days in immediate success and delayed success patients, respectively. Overall, 69.7%, 87.7%, and 91.7% of patients had passed the pregnancy by 14, 28, and 35 days, respectively, after receiving methotrexate. Methotrexate and misoprostol side effects were minimal. This treatment regimen offers an alternative to surgical abortion or the use of antiprogestins and prostaglandin for medical abortion.

Abortifacient Agents, Nonsteroidal↗
PubMed1996

Sperm transport and survival post-application of a new spermicide contraceptive. Advantage 24 Study Group.

The present study was undertaken to evaluate the effectiveness of Advantage 24 to inhibit sperm transport and survival when applied at 24 hours, 12 hours, and 15-30 minutes prior to a single act of intercourse. Conceptrol, applied at 15-30 minutes before intercourse, was employed as the comparative spermicide. One-hundred-thirty-nine women, aged 22 to 45 years, were enrolled into the study and 111 completed the trial. The ability of the spermicides to immobilize sperm was assessed by postcoital testing (PCT) and by examining the proportion of sperm immobilization failure (SIF) rates. SIF was a postcoital test result with > or = 10 sperm with progressive motility (either sluggish or rapid) per x 400 power field. Conceptrol and Advantage 24 used at 15-30 minutes were similar with respect to their ability to inactivate sperm (0% and 2% SIF, respectively, p = 0.5). At longer intervals between spermicidal application and intercourse, less inhibition of sperm motility was noted (9% and 14% SIF for 12 and 24 hours, respectively). The present study indicates that Advantage 24 is an effective agent to immobilize sperm. The action of Advantage 24 may decrease if it is applied earlier than 15-30 minutes before intercourse.

Administration, Intravaginal↗
PubMed1996

Methotrexate and misoprostol for early abortion: a multicenter trial. Acceptability.

A prospective trial was conducted including 300 pregnant women seeking elective abortion to evaluate the efficacy and acceptability of methotrexate and misoprostol for abortion at < or = 56 days gestation. Subjects received methotrexate 50 mg/m2 intramuscularly followed 7 days later by misoprostol 800 micrograms vaginally. The misoprostol dose was repeated the next day if the abortion did not occur. Efficacy is reported elsewhere. Subjects were questioned before the study as to their reasons for choosing a medical abortion and past experience with surgical abortion. After the study was completed, the women were questioned about their medical abortion experience. All questions were asked in an open-ended manner. Main outcome measures included reasons for abortion and study participation, attitudes about the nonsurgical abortion experience, and feelings about preference of nonsurgical or surgical abortion. The most common reason cited as to why women chose to have a nonsurgical abortion was to avoid some aspect of the surgery (48.4%). The percent of women who cited that avoiding surgery was an important reason in their choice of nonsurgical abortion varied by study site and according to whether the woman had a prior surgical abortion. Upon completion of the study, 73.4% of women stated it was a good experience, 19.5% a neutral experience, 7.1% a bad experience, and 1.0% gave no response. When asked what method they would choose if they had to have another abortion, 83.5% would choose this method of medical abortion rather than a surgical abortion. Intramuscular methotrexate and vaginal misoprostol are an acceptable and desirable method of abortion.

Abortifacient Agents↗