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PubMed1999

5-aminolevulinic acid-mediated photodynamic therapy of intraepithelial neoplasia and human papillomavirus of the uterine cervix--a new experimental approach.

The aim of this study was to treat patients for ectocervical dysplasia [cervical intraepithelial neoplasia (CIN) grades 1 and 2] and associated human papilloma virus (HPV) infections with photodynamic therapy (PDT). In 20 patients, 5-aminolevulinic acid (5-ALA, 12% w/v) was applied topically with a cervical cap 8 h prior to illumination. A thermal light source (150 W halogen lamp) emitting a broadband red light (total energy: 100 J/cm2, fluence rate: 90 mW/cm2) was used for superficial illumination of the portio. In addition, an Nd:YAG pumped dye laser (652 nm) was used to illuminate the cervical canal (total energy: 50 J/cm2, fluence rate: 300 mW/cm2). Preliminary results of follow-ups at 1, 3, 6, and 9 months posttherapy showed a cytological improvement in the grading of the PAP smears in 19 patients and the eradication of cervical HPV in 80%. These results demonstrate that ectocervical dysplasia and associated HPV infections can be treated by PDT.

Administration, Intravaginal↗
PubMed1989

Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis.

A multi-centre, randomized, single-blind, parallel-group clinical trial was undertaken in 50 patients (26 fenticonazole, 24 clotrimazole) with symptomatic vaginal candidiasis to compare the antifungal efficacy and tolerability of single-dose intra-vaginal treatment with a fenticonazole ovule (600 mg) or a clotrimazole vaginal tablet (500 mg). Assessment was by laboratory mycological investigation and symptomatic assessments for a period of 3 weeks from the day of treatment. Of the 50 patients, 43 (23 fenticonazole, 20 clotrimazole) returned for assessment 1 week after drug administration and 32 (17 fenticonazole, 15 clotrimazole) were re-assessed 3 weeks after drug administration. Both treatments resulted in very similar and highly significant improvements in symptoms, associated with disappearance of detectable Candida in approximately 70% of patients. There were no significant differences between treatments and no appreciable incidence of relapse during the 3-week period of observation. At the end of this period, 10 (59%) of 17 fenticonazole patients were totally disease-free, as compared with 10 (67%) of 15 patients after clotrimazole treatment. The cure rate observed was somewhat less than that previously seen when intra-vaginal cream formulations of the same two drugs were given on a multiple-dose basis. Both drugs were very well tolerated, with no reports of appreciable local or systemic adverse reactions to either drug.

Administration, Intravaginal↗
PubMedDate not supplied

Acceptability of a novel vaginal microbicide during a safety trial among low-risk women.

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.

Administration, Intravaginal↗
PubMed2000

[Medical indications of labor induction: a comparison between intravaginal misoprostol and intravenous prostaglandin E2].

OBJECTIVES: To assess the effectiveness and safety of misoprostol compared to dinoprostone at term, in cervical priming and labor induction for medical indications. MATERIAL: and methods. Retrospective analysis of 87 patients. 43 patients received intravaginal misoprostol (50microg) and 44 intravenous dinoprostone (0,225 microg/mn with progressive increasing). RESULTS: The mean time from administration to delivery was significantly shorter in the misoprostol group than in the dinoprostone group (10,2 vs 26,0 hours, p<0,01). A significantly greater number of deliveries occurred within 24 hours following administration of misoprostol ( 95 vs 55%, p<0,01). There was no difference in the rates of cesarean section (21 vs 23%, NS), in the rates of tachysystole (30 vs 27%, NS). Hyperstimulations (excessive uterine response: hypertony or tachysystole with non reassuring fetal heart rate) were increased in the misoprostol group, but not significantly (16 vs 7%, NS). Three cesarean sections were performed for hyperstimulation syndrome in the misoprostol group. There was no significant difference between the two agents administered in neonatal outcome or meconial fluid. CONCLUSION: Misoprostol appears interesting in promoting cervical priming and induction of labour at term, but the increased frequency of hyperstimulation and meconial fluid reported in the literature indicate than larger studies than ours are necessary to accurately define the fine incidence of adverse effect. Moreover, dose and administration modalities should be defined by those studies.

Administration, Intravaginal↗
PubMed2004

Ovarian and endocrine responses associated with the treatment of cystic ovarian follicles in dairy cows with gonadotropin releasing hormone and prostaglandin F2alpha, with or without exogenous progesterone.

The objectives of this observational study were to document ovarian and endocrine responses associated with the treatment of cystic ovarian follicles (COFs) in dairy cows, using gonadotropin releasing hormone (GnRH) and prostaglandin F2alpha (PGF) with or without exogenous progesterone. A secondary objective was to determine pregnancy establishment following synchronization of ovulation and timed insemination in cows diagnosed with COFs. In trial I, 18 Holstein cows diagnosed with COFs received 2 injections of 100 microg GnRH, 9 d apart, with 25 mg PGF given 7 d after the 1st GnRH. A new follicle developed in all 18 cows after the 1st GnRH, and 83% of cows ovulated following the 2nd GnRH. Cows were inseminated 16 h after the 2nd GnRH. Of the 17 cows available for pregnancy diagnosis, 7 were confirmed pregnant. In trial II, 8 cows with COFs received GnRH and an intravaginal progesterone device (CIDR) concurrently, then PGF 7 d later. The CIDR was removed 2 d after PGF administration. Plasma estradiol concentrations declined following CIDR insertion. In all cows, a new follicle developed following GnRH treatment; estradiol-surge and estrus occurred spontaneously after CIDR-removal. Seven of 8 cows ovulated the new follicle. In dairy cows diagnosed with COFs, treatment with GnRH followed by PGF 7 d later, with or without exogenous progesterone, resulted in the recruitment of a healthy new follicle; synchronization of ovulation and timed insemination resulted in a 41% pregnancy rate.

Administration, Intravaginal↗
PubMed2005

Local estrogen replacement therapy in postmenopausal atrophic vaginitis: efficacy and safety of low dose 17beta-estradiol vaginal tablets.

PURPOSE OF INVESTIGATION: To verify the effectiveness and safety of low-dose 17beta-estradiol vaginal tablets in the treatment of the postmenopausal atrophic vaginitis. PATIENTS AND METHODS: 325 postmenopausal women with atrophic vaginitis in estrogenic replacement therapy with 0.025 mg 17beta-estradiol vaginal tablets, one application each day for two weeks, and a single application two times a week for the following 22 weeks (total treatment period: 24 weeks). RESULTS: Most of the women reported an improvement of symptoms just after two weeks and minimal incidence of adverse reactions. No patients showed abnormal endometrial thickness and no one had to interrupt the treatment for abnormal uterine bleeding because of systemic absorption. CONCLUSION: Low-dose 17beta-estradiol vaginal tablets in the treatment of the postmenopausal atrophic vaginitis constitutes an extremely valid approach in terms of effectiveness and safety.

Administration, Intravaginal↗
PubMed1990

[Clinical evaluation of high dose rate intra-cavitary irradiation in the treatment of uterine cervical cancer, combined with pepleomycin suppository in uterine cavity].

By means of re-irradiation using pepleomycin suppository in uterine cavity, we attained local control for one patient who had local recurrence in uterine cavity and suffered from uterine fluor in which viable cancer cells were confirmed. We were enlightened by this therapeutic experience, so we attempted combination therapy using pepleomycin suppositories to supplement intra-cavitary irradiation, for the 11 selected patients who were suffering from uterine fluor. We investigated the treatment results in 7 patients of stage III out of 11 patients (of all stages), in comparison with 13 patients of stage III who were treated by irradiation alone. Consequently, these treatment results were approximately equivalent, and the incidence of sigmoid complications could be decreased. Side effects which were followed by the combination therapy were not serious, and so we believe that pepleomycin suppository is a simple method and valuable to supplement radiation therapy of uterine cervical cancer.

Administration, Intravaginal↗
PubMed1994

Disturbances of the endometrium in the luteal phase of cycles stimulated for in vitro fertilization and of normal cycles treated with vaginal progesterone.

Thirty-nine cycles of primarily (n = 32) and secondarily (n = 7) tubal infertile women were studied to evaluate the state of the luteal endometrium in women undergoing In Vitro Fertilization (IVF) without embryo transfer and in women in the normal unstimulated luteal phase with and without vaginal progesterone supplementation. One to four endometrial biopsies were performed in the luteal phase. Serum progesterone (P) and estradiol (E2) as well as the endometrial thickness were estimated on the same days. In groups stimulated for IVF, serum progesterone and estradiol levels were significantly higher (P < 0.01) compared to the control group. The endometrium was significantly thicker and grew more rapidly when cycles were stimulated, but the endometrial thickness did not correlate with endometrial maturation as assessed by histology. The endometrium was disturbed in a major part of the biopsies in all stimulated groups. Progesterone support had no beneficial effect. In women with unstimulated cycles, vaginal progesterone support caused mainly delayed gland maturation: the higher the dose of vaginal progesterone, the sooner the pathological changes in the endometrium were seen. With regard to endometrial histology, vaginal progesterone treatment in the luteal phase of IVF patients may not be advantageous.

Administration, Intravaginal↗
PubMed2003

Comparison of two doses of oestradiol benzoate administered at a resynchronised oestrus on reproductive performance of dairy cows.

OBJECTIVE: To compare the effects of two doses of oestradiol benzoate (ODB) administered as part of a treatment designed to resynchronise returns to oestrus on the reproductive performance of cows in a controlled breeding program. DESIGN: Cohort study. PROCEDURE: Lactating dairy cows on two farms were treated to synchronise three successive oestrous cycles. An intravaginal progesterone releasing insert (IVP4) was used to synchronise the first oestrous cycle. The cows were then treated 15 days after the first treatment by reinsertion of an IVP4 that had been used to synchronise the first oestrus and administration of 1.0 mg of oestradiol benzoate (ODB) i.m. at device insertion. The IVP4 device was removed 8 days later and either 0.5 (n = 421) or 1.0 mg of ODB (n = 446) was administered 24 h later. Injections of (ODB) with or without the use of an IVP4 were used to synchronise the third oestrous cycle. Different synchronisation treatments were used to synchronise first and third oestrous cycles but differences were included in statistical models to account for variation in the data. This enabled examination of effects due to differences in the dose of ODB used to synchronise the second synchronised oestrus. RESULTS: The dose of ODB (0.5 or 1.0 mg) administered just before the second synchronised oestrus did not significantly (P > 0.10) affect the cumulative pregnancy rates over three successive rounds of artificial insemination, the mating start date to the conception intervals, the conception rates to the first or second insemination, the proportion of cows submitted for insemination at the second synchronised oestrus or the proportion of cows that were not pregnant yet failed to show signs of oestrous (phantom cows) identified within each herd. CONCLUSION: There was no difference in reproductive performance between cows receiving either 0.5 mg or 1.0 mg ODB after removal of used IVP4 devices that had been inserted to resynchronise them for a second insemination.

Administration, Intravaginal↗
PubMed1995

Low-dose vaginal misoprostol for induction of labor with a live fetus.

OBJECTIVE: To test the effectiveness and safety of low-dose vaginal misoprostol for induction of labor with a live fetus. METHODS: Labor was induced in 666 pregnant women with a live fetus in the cephalic position, who had no medical complications and no history of uterine surgery. One-fourth of a 200-micrograms tablet of misoprostol (50 micrograms) was placed in the posterior vaginal fornix every 12 h for a maximum of four doses or until active labor commenced. Time from induction to delivery, side effects and neonatal outcome were evaluated. RESULTS: Labor was successfully induced in all cases. The mean time from induction to delivery was 10.4 h. The cesarean section rate was 7.8%. There were eight perinatal deaths, six of which occurred in low birth weight fetuses. There was one case of abruptio placenta, which was less than that expected in the study population. CONCLUSION: Vaginal misoprostol, in very low doses, was a remarkably efficient and safe method for induction of labor with a live fetus.

Administration, Intravaginal↗
PubMed2001

Efficacy of 7-day treatment with metronidazole+miconazole (Neo-Penotran) - a triple-active pessary for the treatment of single and mixed vaginal infections.

OBJECTIVE: To evaluate the efficacy of Neo-Penotran pessaries (metronidazole 500 mg + miconazole nitrate 100 mg) in candidal, bacterial and trichomonal vaginitis and in mixed vaginal infections. METHOD: Ninety-seven patients with clinical diagnosis of vaginitis entered this open, non-comparative study. Each patient inserted one pessary twice daily for 7 days. Gynecological and microbiological assessments were carried out before, and 8-10/21-23 days after the start of treatment. RESULTS: Vaginitis symptoms were resolved in 91% of the 74 patients evaluated, and improved in a further 7%. Microbiological cure rates were 97.3% for trichomonal, 86.6% for bacterial and 81% for candidal vaginitis. Recurrence rates were 2.7, 3.8 and 16.1%, respectively. Overall microbiological cure rate for mixed infections was 86%, with 93% for trichomonal+bacterial, and 73% for bacterial+candidal vaginitis. In two out of three cases with trichomonal+bacterial+candidal infection, the microorganisms were eradicated completely. CONCLUSION: Neo-Penotran provides immediate and effective treatment for vaginitis, irrespective of single or multiple infection, even when the diagnosis may be uncertain.

Administration, Intravaginal↗
PubMed2006

Effects of long-term use of nonoxynol-9 on vaginal flora.

OBJECTIVE: Products containing nonoxynol-9 have been used as spermicidal contraceptives for many years, but limited data have been published describing the long-term effects of nonoxynol-9 use on the vaginal microbial ecosystem. This longitudinal study was conducted to examine the effects of nonoxynol-9 on the vaginal ecology. METHODS: Vaginal swabs were obtained from 235 women enrolled in a randomized clinical trial before initiation of use of 1 of 5 different formulations of nonoxynol-9 for contraception, and up to 3 more samples were gathered over 7 months of use. The swab samples were evaluated in a single laboratory. The prevalence of several constituents of the normal vaginal flora was evaluated. The associations between nonoxynol-9 dosage, formulation, average product use per week, and number of sex acts per week were calculated. RESULTS: The changes in prevalence of vaginal microbes after nonoxynol-9 use were minimal for each of the different nonoxynol-9 formulations. However, when both nonoxynol-9 concentration and number of product uses are taken into account, nonoxynol-9 did have dose-dependant effects on the increased prevalence of anaerobic gram-negative rods (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1-5.3), H2O2-negative lactobacilli (OR 2.0, 95% CI 1.0-4.1), and bacterial vaginosis (OR 2.3, 95% CI 1.1-4.7). CONCLUSION: This study demonstrated that most nonoxynol-9 users experienced minimal disruptions in their vaginal ecology. There were no differences between the different formulations evaluated with respect to changes in vaginal microflora. However, independent of the nonoxynol-9 formulation, there was a dose-dependent effect with increased exposure to nonoxynol-9 on the risk of bacterial vaginosis and its associated flora. LEVEL OF EVIDENCE: II-2.

Administration, Intravaginal↗
PubMed2001

Second trimester pregnancy termination: a comparison of 600 and 800 micrograms of intravaginal misoprostol.

OBJECTIVE: To compare the effectiveness of 600 and 800 microg of misoprostol administered intravaginally every 12 hours for termination of second trimester pregnancies. METHODS: One hundred and forty-three pregnant women at 14-26 weeks' gestation were randomized in 2 groups to receive either 600 microg (N = 67), or 800 microg (N = 76) of intravaginal misoprostol every 12 hours until abortion was induced. RESULTS: The incidences of abortion within 24 hours after initial drug administration were 82.1% (n = 55) and 78.9% (n = 60), within 48 hours 92.5% (n = 62) and 92.1% (n = 70), the mean abortion intervals were 15.2 (10.5, 20.8) hours and 15.3 (10.2, 21.8) hours, the complete abortion rates 77.6% (n = 52) and 72.4% (n = 55), and body temperature of more than 38 degrees C were 26.9% (n = 18) and 71.1% (n = 54, p = < 0.001) in the 600 and 800 microg group, respectively. All other side-effects were similar between the 2 groups. CONCLUSION: In consideration of effectiveness and febrile complication, we suggest that 600 microg applied every 12 hours is the most appropriate dose to use for second trimester termination

Abortion, Induced↗