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PubMed2004

Vaginal microbicides: a novel approach to preventing sexual transmission of HIV.

The AIDS epidemic continues its unrelentless expansion. According to the Joint United Nations Programme on HIV/AIDS, there are more than 40 million people living with HIV, and more than 15,000 new infections occur every day. One approach to curbing HIV is the development of topical microbicidal agents or microbicides. These are compounds designed to protect the body's mucosal surfaces from infection by sexually transmitted disease-causing pathogens, including HIV. Several candidates are in preclinical stages; however, only a handful have been tested in humans for safety, and even fewer are ready for clinical efficacy trials. In this update, we describe microbicide research and development, including preclinical screening algorithms, ideal properties, compounds in the pipeline, and future prospects. This review is based on a previous work, which has been updated to contain new information, especially regarding microbicide candidates in preclinical and clinical stages of development.

Administration, Intravaginal↗
PubMed2003

Advancements in minimally invasive treatments for female stress urinary incontinence: radiofrequency and bulking agents.

Continuous advancements in materials technology have provided the possibility that multiple new urethral bulking agents will be available soon. Experience continues to accrue in clinical trials for urethral bulking with these agents. Parallel use for the indication of pediatric vesicourethral reflux also has provided evidence of biologic activity related to these compounds. All of the agents closest to complete analysis are synthetic and represent a variety of material types and characteristics. As these materials evolve, understanding of the preferential injection technique is being gained. Delivery methods and sites may prove to alter the biologic activity of these compounds substantially. Emphasis on other minimally invasive options for the surgical treatment of stress incontinence also has resulted in the development of radiofrequency vesicourethral suspension. Improved understanding of thermal application to tissue, acute and chronic tissue response to this application, and accumulating human experience with this method of therapy has provided an acceptable tolerability profile for this therapy. This profile may provide application of this method of therapy to an in-office treatment setting, precluding hospitalization and substantially decreasing convalescence times.

Administration, Intravaginal↗
PubMed1987

Comparison of serum progesterone levels in dogs after administration of progesterone by vaginal tablet and vaginal suppositories.

Serum progesterone levels from a vaginal tablet formulation and six different vaginal suppository formulations, each containing 25 mg of progesterone, were evaluated in mongrel dogs. Bioavailabilities relative to an intravenous dose of progesterone were calculated. The vaginal tablet was found to have a significantly higher bioavailability compared with the vaginal suppositories.

Administration, Intravaginal↗
PubMed1989

Effects of estrogen on urethral function in women with urinary incontinence.

In a prospective study, 2 gm of conjugated estrogen vaginal cream was administered daily for a total of 6 weeks in a group of 11 postmenopausal women with urodynamically proved genuine stress incontinence. Midurethral cytologic studies and a complete clinical and urodynamic evaluation were performed twice at 6-week intervals. Clinically, six of the 11 patients (54.5%) were cured or improved significantly after estrogen treatment, whereas the other five patients (45.5%) were clinically unchanged. The favorable clinical response correlated with urodynamic findings of increased urethral closure pressure and improved abdominal pressure transmission to the proximal urethra (p less than 0.05); in the patients who had a poor clinical response to estrogens, no significant changes in urethral dynamics were noted. Changes in urethral cytologic findings also correlated well with clinical and urodynamic findings. Patients with a favorable response to estrogen showed a maturation change from transitional to intermediate squamous epithelium (p less than 0.02), whereas nonresponders showed no significant changes in urethral cells.

Administration, Intravaginal↗
PubMed1991

Uterine rupture at term pregnancy with the use of intracervical prostaglandin E2 gel for induction of labor.

Prostaglandin E2 is a powerful oxytocic agent that reliably initiates labor, even in the presence of an unripe cervix. The low incidence of fetomaternal complication contributes to its universal use. We report a rare case of uterine rupture after intracervical application of prostaglandin E2 gel. Thus far no prostaglandin compound or method of administration seems to be exempt from such a complication.

Administration, Intravaginal↗
PubMed1991

Vasopressin pack for treatment of bleeding after myoma resection.

In 17 women with refractory bleeding after myoma resection a dilute vasopressin pack was applied. Twenty units of vasopressin was diluted with 30 ml normal saline solution. A 1-inch new gauze pack was soaked in the dilute vasopressin and packed into the uteri of patients with bleeding from the beds of resected submucous myomas. The pack was left in place for no more than an hour. In none of the cases was there bleeding after the removal of the pack nor were there any side effects that could be attributed to the vasopressin.

Administration, Intravaginal↗
PubMed1994

A comparative multicenter study of the effects of continuous low-dose estradiol released from a new vaginal ring versus estriol vaginal pessaries in postmenopausal women with symptoms and signs of urogenital atrophy.

OBJECTIVE: Our purpose was to study the efficacy, safety, and acceptability of a new estradiol-releasing (6.5 to 9.5 micrograms per 24 hours) silicone rubber vaginal ring compared with Ovesterin 0.5 mg estriol vaginal pessaries. STUDY DESIGN: Gynecologic clinical status, vaginal pH, cytologic characteristics, and occurrence of bacteriuria were determined before starting and after 3 and 12 weeks of treatment in 146 postmenopausal women. RESULTS: Both treatments alleviated the subjective and objective symptoms of estrogen deficiency excellently, and both were equally effective at restoring the vaginal pH to levels normally seen in fertile women (< 5.5). Vaginal cytologic studies showed a significant difference in maturation value in favor of the estradiol-releasing silicone rubber vaginal ring, as measured by the pathologist's assessment of the proliferation of the vaginal mucosa. A total of 77% of users were classified as responders, compared with 39% in the pessary group. Both treatments were well accepted. The administration of the pessary was associated with a significantly higher (p < 0.001) incidence of discomfort than that of the ring, which was given better (p < 0.001) rating by the patients at the 12-week visit. A strong preference (p < 0.001) for the ring was shown by patients with previous experience with pessaries. CONCLUSION: Treatment of urogenital symptoms in postmenopausal women with an estradiol-releasing vaginal ring is shown to be an effective and safe method, exhibiting advantages over treatment with estriol vaginal pessaries.

Administration, Intravaginal↗
PubMed1994

Fetal urine production after induction of labor with prostaglandin E2.

The effect of prostaglandin E2 on fetal urine production was examined in women undergoing labor induction. An effect may be expected, because the administration of indomethacin, a potent antiprostaglandin, has been shown to cause a decrease in fetal urine production and subsequent oligohydramnios. The mean hourly fetal urine production before and 4 hours after vaginal application of prostaglandin E2 were similar (38 and 43 ml per hour, respectively). The application of prostaglandin E2 need not be taken into consideration when fetal urine production is assessed.

Administration, Intravaginal↗
PubMed1986

Therapeutic abortion in early pregnancy with antiprogestogen RU486 alone or in combination with prostaglandin analogue (gemeprost).

Abortion was attempted in 39 women in early pregnancy (less than 56 days amenorrhea) with the progesterone antagonist RU486 alone (150 mg per day for 4 days) or in combination with a PG analogue, 16,16-dimethyl-trans-delta 2-PGE1 (Gemeprost) in the form of a 1 mg vaginal pessary. Complete abortion was also attempted in 5 women who received RU486 together with 2 X 1 mg PG pessaries. Vaginal bleeding followed by complete abortion occurred in 18 of 19 women who received RU486 + 1 mg PG pessary as compared to only 12 of 20 women who received RU486 alone (P less than 0.01). All women who received RU486 + 2 mg Gemeprost had a complete abortion. The onset of crampy abdominal pain (median: 3 vs 4 days) and vaginal bleeding (3 vs 3 days) was similar in the RU486 and RU486 + PG groups, respectively. Slightly less than half the patients in both groups had nausea and/or vomiting, but the incidence did not differ from that occurring prior to treatment. The mean duration (range) of vaginal bleeding [RU486 alone: 10 (0,29) days and RU486 + PG: (5,34) days], and the measured blood loss [RU486: 53 (2,227) ml and RU486 + PG: 81 (32,222) ml] did not differ significantly between the two treatments. It is concluded that the combination of RU486 and a single PG vaginal pessary is a highly effective means of inducing therapeutic abortion in early pregnancy and offers an alternative to surgery.

Abortifacient Agents↗
PubMed1988

Vaginal bleeding patterns among women using one natural and eight hormonal methods of contraception.

Menstrual diary records were obtained from a total of 5257 women using nine different methods of contraception, one natural and eight hormonal. This paper presents a comparative analysis of their vaginal bleeding patterns. The analytic procedures follow the recommendations of a recent WHO workshop on bleeding pattern analysis, which involve dividing each subject's diary into successive 90-day reference periods, calculating ten indices for each period, and classifying women according to whether they have "clinically important" bleeding disturbances. In general, the findings of this analysis confirm those of previous studies. Women using the natural method, who were deliberately selected for the regularity of their menstrual cycles, averaged three bleeding/spotting episodes of length 5 days in each 90-day period, with very little variability within or between women. Subjects given a combined oral contraceptive had more regular patterns than any other treated group, with short (4-day) episodes and 23-24 day bleeding-free intervals. Progestogen-only pill users had more frequent, longer episodes and shorter, less predictable intervals than combined pill users. Contrary to widely-held beliefs, the progestogen-only pills produced fewer spotting days than the combined pills, and almost no spotting episodes at all. Nearly half of vaginal ring users experienced some menstrual disturbance in each period; their most common problems were irregular, infrequent or prolonged bleeding. Women using the long-acting injectable, depot medroxyprogesterone acetate, had totally unpredictable patterns, with infrequent but prolonged bleeding/spotting episodes. The incidence of amenorrhea rose from just under 10% in their first injection interval to over 40% in their fourth. The methods of analysis recommended by WHO in 1985 still require substantial refinement. Nevertheless, they are more sensitive than those used previously for WHO trials and produce an easily understood, clinically meaningful characterization of bleeding patterns.

Administration, Intravaginal↗
PubMed1988

The association between vaginal bleeding patterns and reasons for discontinuation of contraceptive use.

This paper describes the relationship between menstrual bleeding patterns recorded and reasons for discontinuing method use given by women using one of four types of hormonal contraception: combined oral pills, progestogen-only oral pills, a vaginal ring or depot-medroxyprogesterone acetate (DMPA). The women were recruited to five clinical trials, each of which lasted at least 48 weeks. The subject's reason for discontinuation was recorded if she stopped contraceptive use before the scheduled time. Overall, the reason expressed for discontinuing method use was a close reflection of the subject's experience. Among women using either type of oral contraceptive or a vaginal ring, subjects who discontinued for a non-menstrual reason or were lost to follow-up had bleeding patterns which did not differ markedly from those of women who continued method use. Only in the DMPA group was there any evidence that women who complained of non-menstrual side effects or were lost to follow-up might have ceased method use because they were unwilling or unable to tolerate their bleeding patterns. Subjects who discontinued because of amenorrhea had few bleeding/spotting days and at least one prolonged bleeding-free interval; women who complained of longer bleeding had long episodes and short intervals. Women who reported heavier bleeding had patterns which were similar to, but less extreme, than those of subjects who reported longer bleeding. The complaint of irregular bleeding, however, did not concur with the bleeding patterns recorded, regardless of contraceptive method. The predominant menstrual disturbance in this group of women was frequency of bleeding. They had no special difficulty in predicting either the time of onset or the length of their bleeding episodes. There were marked differences between individuals in terms of their acceptance of bleeding disturbances. Nevertheless, the results of this study confirm the importance of counselling. Women using DMPA tolerated far greater menstrual disruption than subjects using any other method. Subjects using an oral contraceptive were unlikely to have been warned of potential bleeding problems; when they encountered any, they tended to cease method use. In contrast, subjects using DMPA would have been advised to expect irregular patterns and possibly amenorrhea; prepared for such disturbances, their perseverance was remarkable.

Administration, Intravaginal↗
PubMed1988

Determinants of menstrual bleeding patterns among women using natural and hormonal methods of contraception. I. Regional variations.

Records of the occurrence of vaginal bleeding were obtained from women using either a natural method of contraception or one of four types of hormonal contraceptive. The relationships between their bleeding patterns and a number of demographic variables were examined, with the aim of identifying subgroups of women who, if they used a particular hormonal method of contraception, would be likely to suffer more or less disruption to their bleeding pattern than the 'norm'. Within contraceptive method, bleeding patterns were more closely related to the women's geographical region of residence than to any other factor. Some of the differences between regions were consistent across contraceptive methods. European women tended to have more bleeding/spotting days than women in other regions; Latin American women had relatively short episodes and long bleeding-free intervals, whether they were using the ovulation method, combined pills or a vaginal ring. Other differences were method-specific. Women using combined pills in India or Pakistan had fewer spotting episodes than women using the same method elsewhere; those using progestogen-only pills had more. Regional variations in bleeding patterns were particularly marked among women using DMPA, and increased over time: by their fourth injection interval, 25% of European women had amenorrhea, as compared with 72% of subjects in North Africa. These findings need to be confirmed by carefully controlled studies of menstrual bleeding patterns and their acceptability in various ethnic groups. The results would be valuable in counselling new contraceptive acceptors, and could eventually guide the choice of methods for introduction into national family planning programmes.

Administration, Intravaginal↗
PubMed1988

Determinants of menstrual bleeding patterns among women using natural and hormonal methods of contraception. II. The influence of individual characteristics.

Menstrual diary records were obtained from women using either a natural method of contraception, a combined or progestogen-only oral contraceptive, a vaginal ring, or a long-acting injectable (DMPA). Within each method group, multiple regression analysis was used to examine the relationships between the subjects' bleeding patterns and their age, age at menarche, ponderal index, obstetric and contraceptive history and ethnic origin. The influence of ethnic origin was described in the preceding paper. Among combined pill users, increasing age was associated with more frequent spotting episodes. In both the untreated and combined pill groups, women with a higher ponderal index had less variable bleeding-free intervals; in the vaginal ring and DMPA groups, the more obese women had shorter bleeding/spotting episodes and longer bleeding-free intervals. Among combined oral contraceptive users, the most influential variable was the time since the end of the woman's last pregnancy: subjects who had been more recently pregnant had longer, less predictable episodes and shorter intervals. Previous oral contraceptive use was associated with more predictable bleeding patterns among women currently using either type of oral pill. In the vaginal ring and DMPA groups, subjects whose last pregnancy had ended in abortion had more bleeding/spotting days and episodes than those who had had a live birth. As reported previously, bleeding patterns were more closely related to the woman's geographical region of residence than to any other factor. The associations found with other individual characteristics were often inconsistent or difficult to interpret. A number of variables which could potentially influence menstrual bleeding patterns, such as nutritional status, were not measured and therefore could not be included in the analysis. However, contraceptive method and ethnic origin may be predominant influences, overriding any other factor.

Abortion, Induced↗
PubMed1989

Pharmacodynamics of a contraceptive vaginal ring releasing 3-keto-desogestrel.

The pharmacodynamic effects of a new type of 3-keto-Desogestrel [3kDOG] releasing vaginal ring was studied in a group of 20 normally ovulating women during a period of 21 days continuous use. Peripheral blood samples were taken for the estimation of progesterone and oestradiol levels, ultrasound tracking for follicular growth and cervical mucus sampling for scoring [modified Insler] and sperm penetration testing during a control, treatment and recovery period. Additional blood samples were taken for the estimation of 3kDOG levels during the treatment period. After a control cycle, twenty normally ovulating women were selected and randomly divided into two groups. Group A were given a vaginal ring on day 5 of the menstrual cycle releasing 30 ug/24 hours of 3kDOG and group B a similar ring releasing 15 ug/24 hours of kDOG. Of the treatment cycles, none showed an ovulatory pattern in group A and there was only one in group B, the respective mean plasma levels of 3kDOG were 0.38 and 0.25 pmol/ml. The formation of "cysts" or persistent follicles was common to both groups, 6 out of 10 subjects in group A and 8 out of 10 subjects in group B had "cysts" greater than 25mm in diameter in the treatment cycle, this had become 5 out of 10 and 8 out of 10, respectively, in the recovery cycle. A comparison of the cervical mucus scores and sperm penetration of cervical mucus showed a significant reduction between the control and treatment groups but no significant difference between the two groups. The bleeding profiles showed an increase in percentage of bleeding days in both treatment groups to 25% in group A and 21.7% in group B [cf, 17.1%, 15.9%, respectively, in control month]; there being no statistical difference between groups. In conclusion, it is believed that given the efficacy demonstrated and the low level of menstrual disturbances found, this system warrants further investigation as a means of contraception as it appears to offer a better compromise than previous vaginal ring systems.

Administration, Intravaginal↗
PubMed1989

Comparative trial between two soft jelly capsules containing nonoxynol as spermicidal contraceptives.

The rupture time of two types of soft jelly capsules (treated and non-treated) containing Nonoxynol-9 after its vaginal insertion was investigated in 96 women. Subjects were allocated in four study groups: Group I (n = 24), women with clinical vaginal infection; Group II (n = 24), subjects without vaginal infection; Group III (n = 24), patients with vaginal infection; and Group IV (n = 24), women without vaginal infection. Groups I and II received the treated capsules, and Groups III and IV the non-treated capsules. The capsules remained in the vagina for 2.5 to 5 minutes. The weight of the capsules was measured before insertion and after their extraction. Additionally, vaginal pH and distribution of the compound were assessed. The results disclosed that in Groups I, III and IV, the capsules ruptured within 2.5 minutes, whereas in Group II the rupture did not occur until 3 minutes. The largest number of non-ruptured capsules was observed in Group II. The major capsule weight loss occurred at minute 5 in most of the groups. The conditions currently observed in cases of non-ruptured capsules were: alkaline pH, multiparity and vaginal dryness. The vaginal distribution of the compound was observed at its upper portion. In women with vaginal infections, there were more cases of rupture and a significant weight loss between the treated capsules than the non-treated capsules. Further postcoital tests are required to assess its effectiveness.

Administration, Intravaginal↗
PubMed1989

The in vivo release characteristics of a multi-compartment vaginal ring releasing 3-keto-desogestrel.

The results of a stage I study of a new vaginal ring releasing 3-keto-Desogestrel [3kDOG] is reported. The study design consisted of one study cycle, where the ring was used continuously for 21 days and then removed. Twenty healthy volunteers were randomly allocated to each of two study groups. On day 5 of the menstrual cycle, group A used a vaginal ring releasing 30 micrograms 3kDOG per 24 hours and group B used a 15 micrograms 3kDOG per 24 hours ring. After initial absorption of the 3kDOG a plateau phase was reached in 46 hours [group A] and 49 hours [group B]. On reaching the plateau phase, the overall decline in plasma levels during the 21 days of use was 5.24% for group A and 5.27% for group B. This represents a daily decline in plasma levels of 0.27% and 0.28% for the 30 micrograms and 15 micrograms per 24 hours rings, respectively. The plasma levels achieved by the rings were significantly different throughout (p = 0.011). On removal after 21 days, the mean removal half-life for both ring types was similar at 20.9 hours for group A and 21.1 hours for group B. It is concluded that the characteristics of the delivery system are worthy of further study as a potential means of contraception using 3kDOG delivered from a vaginal ring.

Administration, Intravaginal↗
PubMed1990

Comparison of the clinical performance, contraceptive efficacy and acceptability of levonorgestrel-releasing IUD and Norplant-2 implants in China.

The levonorgestrel-releasing IUD (LNG-IUD, 20 micrograms/d) and the Norplant-2 implants were studied in a randomized comparative clinical trial with 200 women for one year. No pregnancy or expulsion occurred with the Norplant-2. In the LNG-IUD group, there was one pregnancy at the 12th month of use after an unnoticed expulsion. The net cumulative pregnancy and expulsion rates of LNG-IUD were 1.0 and 3.0. The removal rate due to menstrual disturbances in both LNG-IUD and Norplant-2 groups was 3.0. The use-related discontinuation rates were 9.0 and 3.0, and the continuation rates were 90.0 and 96.0, respectively. The differences were not statistically significant. Menstrual disturbance was the main side effect. It was improved after long time use, especially in the LNG-IUD group. After one year, the percentages of women with amenorrhea were 18.9 for the LNG-IUD and 8.3 for the Norplant-2. The menstrual blood loss was statistically significantly reduced in the LNG-IUD group, and blood haemoglobin concentration increased in both groups. The LNG-IUD and Norplant-2 are highly effective, safe, long-acting, and well accepted by the Chinese women.

Administration, Intravaginal↗