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PubMed2004

Emetine ditartrate: a possible lead for emergency contraception.

Interception of pregnancy in its initial stage is an attractive and viable approach to contraception. A chemical agent, taken within the first few days of missed menses, intercepts the conception, which is expelled with menstrual flow. The main targets of such agents are the uterus, blastocyst and the growing trophoblasts, whose nutritional requirement is inhibited. Our previous work has identified several nonsteroidal chemical entities as pregnancy interceptives in rodents and infrahuman primates. However, none reached clinical stage due to their ineffectiveness by oral route. Nevertheless, parallel to these rationally designed synthetic compounds, a program was ongoing to identify natural product(s) that can be used as interceptives. We are reporting for the first time the detailed profile of emetine ditartrate, a compound whose pregnancy interceptive efficacy has been studied in mouse, rat, hamster, guinea pig and rabbit by oral and intravaginal routes of administration. By the oral route, the compound caused 100% resorption of the fetuses in rat, hamster and guinea pig at 6.0, 5.0 and 3.0 mg/kg, respectively, on administration during peri- and early postimplantation periods of pregnancy (depending upon the day of implantation in each species). By intravaginal route, the compound was administered once in the form of a vaginal pessary on the day of implantation in respective species; interception of pregnancy was not achieved completely in rat and hamster at doses four to five times the oral dose in multi-day schedule. However, in guinea pig and rabbit it was fully effective at 7.0 and 70.0 mg/animal, respectively. The compound was devoid of estrogenic, antiestrogenic and progestational activity but possessed mild antiprogestational activity at the high dose in vivo. In in vitro assay, however, it did not show any significant binding to estrogen and progesterone receptors. The mode of action of the compound was found to be mainly on the uterus and early embryos around implantation, possibly on the trophoblasts and endometrial cells at the attachment site. The absence of 100% efficacy in rat and hamster by intravaginal route, but not by oral route, is possibly due to poor absorption of the compound through the vagina in these species. The guinea pig and rabbit, therefore, seem the better species for evaluating the efficacy of the compound administered by the vaginal route.

Administration, Intravaginal↗
PubMed1995

Randomized comparison of the effects of endocervical and vaginal prostaglandin E2 gel in women with various degrees of cervical ripeness. Dutch Collaborative Prostaglandin Trialists' Group.

OBJECTIVE: The trail was conducted to obtain an unbiased comparison of the relative merits of endocervical and vaginal prostaglandin E2 gel in a weighted case mix of parous and nulliparous women with favorable and unfavorable cervical features. STUDY DESIGN: Multicenter randomized trial with 285 participants, (three exclusions) was performed with sealed envelopes stratified for parity and Bishop score. RESULTS: Outcomes of labor and delivery were clearly related to the cervical score at trial entry, especially in nulliparous women. Endocervical prostaglandin E2 had a more marked effect on cervical ripeness than did vaginal prostaglandin E2, but this did not result in any differences in more substantive outcomes. Frequencies of delivery within 12 (50%) and 24 hours (77.7%), cesarean section (7.3%), instrumental vaginal delivery (11.7%), and poor infant outcomes were similar with both preparations. CONCLUSION: Because differences in effectiveness between endocervical and vaginal prostaglandin E2 in triacetin gel are marginal, preferences of women and clinicians can determine the choice between them.

Administration, Intravaginal↗
PubMed1999

A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and withdrawal bleeding.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of 2 doses of a transvaginal polycarbophil-based progesterone gel (4% and 8%) in hormone replacement therapy. STUDY DESIGN: This multicenter, randomized, parallel-group, open-label 3-month study included 127 women with secondary amenorrhea. Estrogenized patients applied transvaginal progesterone (4% or 8%) every other day for 6 doses per month. Efficacy was based on endometrial biopsy findings and withdrawal bleeding. McNemar's test was used to compare incidence of adverse events before and during treatment. RESULTS: Progestational changes were found in 92% (Crinone 4%) and 100% (Crinone 8%) of patients with evaluable biopsies. Withdrawal bleeding was experienced by 81% (Crinone 4%) and 82% (Crinone 8%) of the patients. No patient experienced any serious side effect related to treatment. The incidence of most side effects, including psychologic symptoms, decreased with progesterone treatment compared with estrogen alone therapy. Compliance exceeded 98% for both doses. CONCLUSIONS: Crinone is a novel, effective, and well-tolerated option for hormone replacement therapy in women with secondary amenorrhea.

Administration, Intravaginal↗
PubMed1997

Estradiol delivery by vaginal rings: potential for hormone replacement therapy.

OBJECTIVES: To determine if delivery of estradiol from elastomeric vaginal rings gives estradiol blood levels in the range associated with effective estrogen replacement therapy and to determine the relation between in vitro estradiol release from the rings and blood levels in vivo. Secondary objectives related to changes in lipoprotein cholesterol, changes in climacteric symptoms, and evaluation of acceptability to users. METHODS: Three ring variants releasing approximately 100, 150 and 200 micrograms/day of estradiol in vitro were used through 22 days in 21 postmenopausal women, 7 on each dose levels. Blood samples for measurement of estradiol were taken at 3-4 day intervals. Lipoprotein cholesterol was measured before and at the end of treatment. Women were questioned about climacteric symptoms and about their satisfaction with the ring. RESULTS: Mean serum estradiol levels for the three groups of rings were 63 +/- 6, 94 +/- 5 and 136 +/- 13 pg/ml for the 100, 150 and 200 micrograms/day rings, respectively. FSH levels declined during ring use and the maturation values of cells collected on vaginal swabs markedly increased. Total and LDL cholesterol were significantly reduced and HDL cholesterol was not significantly changed. All women reported relief of postmenopausal symptoms. Vaginal discomfort during the first 3 days of use was reported by 12 women but overall satisfaction with the method was high. CONCLUSIONS: Women using the vaginal rings attained estradiol blood levels compatible with control of climacteric symptoms and bone loss. The relation between in vitro estradiol release and blood levels in vivo was essentially identical for all 3 doses. The use of vaginal rings to deliver estradiol for hormone replacement therapy is judged to merit further evaluation.

Administration, Intravaginal↗
PubMed2004

Obstetric outcomes after cervical ripening by multiple doses of vaginal prostaglandin E2.

AIM: The study was designed to investigate the delivery outcome in women who required vaginal prostaglandin E2 for cervical priming prior to labor induction. MATERIALS AND METHODS: This retrospective cohort study included all singleton term deliveries that required labor induction over a 3-year period. Incidence and indications of obstetric interventions were compared among women who required different doses of vaginal prostaglandin E2 for cervical priming and who had induction by amniotomy and oxytocin infusion. RESULTS: Of 706 deliveries, 411 had favorable Bishop's scores and no vaginal prostaglandin E2 for cervical priming was required (group A); 268 required one or two doses of vaginal prostaglandin E2 for cervical priming (group B); and 27 required three or more doses (group C). The incidence of cesarean section was significantly higher in group C (48.1%) than in group A (19.0%) and group B (16.4%). The difference remained statistically significant when primiparous and multiparous women were analyzed separately. The risk of obstetric intervention was particularly high in primiparous women in group C (58.8% required emergency cesarean section and 23.5% had instrumental delivery). There was an increased frequency of all major indications for cesarean section in group C. CONCLUSION: The risk of emergency cesarean section was higher in women who required more than two doses of vaginal prostaglandin E2 for cervical priming compared to induction by one or two doses of vaginal prostaglandin E2 or by amniotomy and oxytocin infusion. These women should be informed regarding the high risk of intrapartum cesarean section, and the option of alternative methods of induction or elective cesarean section should be made available.

Administration, Intravaginal↗
PubMed2002

Magnetic resonance imaging to determine the distribution of a vaginal gel: before, during, and after both simulated and real intercourse.

To provide effective contraception and protection against sexually transmitted disease, vaginal gels should maximally cover the cervical os and the vaginal epithelium before, during and after intercourse. To non-invasively monitor the intravaginal distribution of an applied intravaginal gel, we performed high-resolution magnetic resonance imaging (MRI) of the female pelvis before, during and after both real and simulated sexual intercourse. We sought to determine whether simulated intercourse with a plastic phallus could be used as a surrogate for real intercourse for such experiments. Dilute gadolinium chelate solution was mixed with Gynol-II gel and introduced intravaginally to volunteer female human subjects using a conventional applicator. MRI was performed at 1.5 Tesla with a surface coil. Imaging of the female pelvis was performed: (1) immediately after insertion of the gel; (2) during real intercourse with a male partner (2 subjects) or simulated intercourse with a plastic phallus (4 subjects); and (3) after completion of real or simulated intercourse. Subjects were studied after application of both 3 mL and 5 mL of vaginal gel. Measurements of gel thickness covering the vaginal mucosa were made digitally using electronic calipers. The bolus of gel is initially located in the upper vaginal canal, superior to the urogenital diaphragm. Both real and simulated intercourse dramatically increases the spread of gel to the lower vagina. The cervix appears to be adequately covered with gel both before and after intercourse. Increasing the volume of the gel increases initial vaginal mucosal coverage but also increases leakage from the introitus. No statistically significant differences in vaginal mucosal coverage were found between patients having undergone real vs. simulated intercourse, or on post-intercourse scans of 3 mL versus 5 mL. MRI is a sensitive, reproducible means of tracking the spread of intravaginal medications.

Administration, Intravaginal↗
PubMed2000

Uterine rupture associated with vaginal birth after cesarean section: a complication of intravaginal misoprostol?

Intravaginal misoprostol has become increasingly employed for labor induction among patients with an unfavorable Bishop's score. Almost all of the reported studies have specifically excluded patients with prior uterine surgery. There has been, therefore, very little information concerning its usage among patients attempting vaginal birth after cesarean section. We report a patient with two prior low transverse uterine incisions who experienced uterine rupture after having received a single 25-microg intravaginal dose of misoprostol.

Administration, Intravaginal↗
PubMed1993

Effects and acceptability of a new 17 beta-oestradiol-releasing vaginal ring in the treatment of postmenopausal complaints.

The treatment of postmenopausal symptoms was studied in 26 healthy women using a new synthetic rubber (Kraton D 2109) vaginal ring containing 53 mg of 17 beta-oestradiol. All women were postmenopausal, at least 6 months after the last vaginal bleeding and suffering from daily hot flushes. The study was conducted in a double-blind placebo-controlled intrapatient cross-over fashion, and the study period was 6 months. The rings used give an initial in vitro release rate of 0.4 mg/E2 per day. The in vitro release rate decreases to about 0.2 mg/day after 20 days and levels off asymptotically to about 0.1 mg/day after 50 days. Serum E2 levels equivalent to the follicular phase of the normal menstrual cycle were measured after 1 month's use, and serum E2 level stayed above postmenopausal levels throughout the study period. FSH was suppressed during use of the E2-releasing vaginal ring, while LH showed no statistically significant suppression in continued use. Postmenopausal complaints were recorded by Visual Analogue Scales (VAS) as judged by both the patient and the examining doctor; all complaints had favourable outcomes during use of the E2-releasing vaginal ring without deterioration of symptoms during use of the placebo ring. No serious side-effects were encountered, and the possibility of managing all postmenopausal complaints with intravaginal oestrogen treatment is discussed.

Administration, Intravaginal↗
PubMed1994

Endometrial hyperplasia: efficacy of a new treatment with a vaginal cream containing natural micronized progesterone.

Seventy-eight premenopausal women affected by benign endometrial hyperplasia (60 simple and 18 complex) were treated from the 10th to the 25th day of the menstrual cycle with a vaginal cream containing 100 mg of natural micronized progesterone in polyethylene glycol base. The treatment lasted 3 months in 58 patients and 6 in the other 16 patients. Four patients were lost from the study. We observed a total of 67 complete regressions (90.5%) of which 58 (78.3%) occurred in the first 3 months and 9 (11.5%) after 6 months of treatment. Simple hyperplasia showed a significantly higher response to treatment in comparison with the complex type (P < 0.001). The most frequent endometrial pattern detected in the patients in whom hyperplasia regressed was of a secretive type. Recurrence of hyperplasia occurred in 1 out of 58 (1.72%) patients at the 3rd month and in 3 out of 49 (6.1%) patients at the 6th month after treatment. There were no significant differences between the two hystological groups in the percentage of recurrence. During treatment we observed a significant reduction of the amount, duration and frequency of the menstrual bleeding. Minimal side-effects were observed. In conclusion, for its effectiveness and safety, vaginal administration of natural micronized progesterone seems to be an interesting approach to benign endometrial hyperplasia, particularly indicated in women also affected by metabolic disorders.

Administration, Intravaginal↗
PubMed2005

Misoprostol use for labor induction in developing countries: a prospective study in Guinea.

BACKGROUND: The purpose of this study was to assess the efficacy, side effects and cost of misoprostol regimens in various obstetrical situations frequently occurring in developing countries. STUDY DESIGN: One hundred and four parturient women with indications for labor induction received different regimens of misoprostol in the range of 50-800 microg according to their gestational age. Misoprostol was administered by the vaginal route, every 6h without exceeding four doses. RESULTS: All indications for labor induction concerned women with a gestational age of more than 30 weeks, except in the intrauterine death cases. The mean overall duration of labor was 7.8 h (+/-4.6 h). The mean amount of misoprostol used was 226 microg (+/-196 microg). The difference in the mean labor duration between the four indications for induction was statistically significant (P<0.01). It was also significant for the mean total dose of misoprostol used. Total dose of misoprostol and Bishop score were inversely proportional. Two caesarean deliveries and two uterine ruptures were recorded, but no maternal deaths. The mean Apgar score was 8.0 (+/-1) at 1 min and 9.5 (+/-0.8) at 5 min. In our series, four fetal deaths occurred. The mean cost of misoprostol for labor induction was around US$ 1, with a range of 0.05-4. CONCLUSIONS: The use of vaginal misoprostol appears to be relevant in developing countries in cases where labor induction is indicated. Nevertheless, the advantages of misoprostol (low cost, facility of storage) are counter-balanced by side-effects (C-section, uterine rupture) which can be harmful for the mother and also for the newborn.

Administration, Intravaginal↗