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PubMedDate not supplied

A new approach for the treatment of bacterial vaginosis: use of polyhexamethylene biguanide. A prospective, randomized study.

BACKGROUND: Bacterial vaginosis (BV) is the most common vulvovaginal infection and represents the 35% of all the infections occurring in women in the reproductive age. It is well recognised that serious forms of BV can induce several complications among women undergoing gynaecologic or obstetric surgery, having pelvic inflammatory diseases, temporary or absolute infertility, miscarriage and abortion. At present, the clinical treatment of choice of BV is the use of systemic or local (gel or cream) metronidazole and clindamycin, though systemic use has some limitations due to side-effects and contraindications. Polyhexamethylene biguanide (PHMB) is a new bi-biguanide compound having a broad spectrum activity and low toxicity, that have been successfully utilized in ophthalmology and dentistry. Aim of this study was to evaluate the efficacy and tolerability of a single-dose vaginal administration of a PHMB vaginal gel in the treatment of BV in comparison to clindamycin vaginal cream. METHODS: One-hundred and ten patients affected by BV were treated with PHMB vaginal gel in single administration or clindamycin vaginal cream 1 daily administration for 7 days. RESULTS: We demonstrated the therapeutic efficacy of mono-dose administration of a vaginal solution containing PHMB in BV treatment; this efficacy is similar to the one shown in antibiotic therapy. Furthermore, this product was well tolerated by all treated patients. CONCLUSIONS: Mono-dose PHMB treatment should be regarded as the therapy of choice for BV, using clindamycin and metronidazole only for relapses treatment.

Administration, Intravaginal↗
PubMed1997

Intramuscular versus vaginal progesterone in assisted reproduction: a comparative study.

The effectiveness and the absorption of two progesterone (P) presentations have been compared for luteal phase support of patients aged < or = 37 years undergoing an in vitro fertilization (IVF) procedure for the first time, who were stimulated after pituitary desensitization with gonadotrophin releasing hormone agonists (GnRHa). All of them had two ovaries, normal ovarian functions and normal endometrial morphology: the indication for the assisted reproductive technique was the tubal factor. Two hundred and fifty patients were randomly allocated to two groups in order to compare two treatment protocols: Group A: natural i.m. P (50 mg/day, Prontogest, AMSA, Italy); Group B: micronized vaginal P (200 mg/day Esolut, Angelini, Italy). We were able to show that the i.m. P resulted in a higher percentage of pregnancies than the vaginal preparation, with statistically significant differences. We recommend the use of injectable P, and suggest reserving intravaginal P as a second choice for patients who cannot tolerate intramuscular administration.

Administration, Intravaginal↗
PubMed2005

Intravaginal misoprostol 600 microg and 800 microg for the treatment of early pregnancy failure.

OBJECTIVE: To compare the respective effectiveness and safety of 600 microg and 800 microg of intravaginal misoprostol for complete abortion in cases of early pregnancy failure (occurring in the first 12 weeks). METHOD: A total of 114 women with a diagnosis of early pregnancy failure made by transvaginal ultrasonography at Rajavithi Hospital between November 25, 2002 and July 31, 2003, were assigned randomly to 2 groups of equal size. In one group the women received 600 microg of misoprostol and in the other 800 microg of misoprostol intravaginally. RESULTS: The rate of complete abortion within 24 h was significantly higher in the group that received 800 microg of misoprostol (68.4%) than in the other group (45.6%) (P<0.05). There were no significant differences between the 2 groups regarding time interval between misoprostol insertion and complete abortion or side effects. CONCLUSION: Intravaginal misoprostol 800 microg is significantly more effective than vaginal misoprostol 600 microg for the termination of an early pregnancy failure, with no significant differences in side effects.

Abortifacient Agents, Nonsteroidal↗
PubMed1994

Double-blind comparison of intracervical and intravaginal prostaglandin E2 for cervical ripening and induction of labor.

OBJECTIVE: Our purpose was to compare the safety and effectiveness of prostaglandin E2 delivered sequentially as an intracervical (0.5 mg) or intravaginal (2.5 mg) gel. STUDY DESIGN: Hospitalized patients with an unfavorable cervix (Bishop score < or = 4) at > or = 35 weeks and requiring induction of labor were assigned to receive two 2.5 ml doses of gel intracervically and intravaginally in a double-blind, placebo-controlled manner. Second and third doses were given at 6-hour intervals until there were either regular uterine contractions or a Bishop score change > 3 points. RESULTS: The 100 evaluable cases received prostaglandin E2 either intracervically (n = 52) or intravaginally (n = 48). Difficulty with exact gel instillation was present with intracervical gel only, where spillage occurred in 85% of cases. Compared with intracervical therapy prostaglandin E2 given intravaginally was more likely to significantly change the Bishop score (60.4% vs 40.4%, p = 0.04) and stimulate regular contractions (72.9% vs 48.1%, p = 0.01). Uterine hyperstimulation was present in one case in each group. CONCLUSION: Although each was safe, instillation of prostaglandin E2 gel was better at a higher intravaginal dose than a lower intracervical dose because of its greater ease of administration and higher likelihood of cervical change.

Administration, Intravaginal↗
PubMed2003

Prediction of adverse outcome associated with vaginal misoprostol for labor induction.

OBJECTIVE: To identify predictors of adverse outcome in pregnant women at term receiving 50 microg of intravaginal misoprostol for labor induction. STUDY DESIGN: A prospective observational study was conducted of 720 pregnant women at term with an unfavorable cervix and a medical or obstetric indication for labor induction. All patients received 50 microg of intravaginal misoprostol every 4h up to three doses. The primary outcome measure was "adverse outcome" defined as: neonatal death, fetal acidemia and emergent cesarean delivery performed for non-reassuring fetal heart rate tracings. A stepwise logistic regression analysis was used to identify predictors of adverse outcome. RESULTS: Tachysystole (frequent uterine contractions) (odds ratio (OR), 3.7; 95% confidence interval (CI), 1.2-10.8) and fetal tachycardia (OR, 4.8; 95% CI, 1.4-16.2) were determined as significant predictors of adverse outcome. The specificity of the model was 94.2%, whereas the sensitivity was 20.4%. CONCLUSION: In the absence of tachysystole and fetal tachycardia, an uneventful delivery might be expected for women receiving 50 microg of intravaginal misoprostol.

Administration, Intravaginal↗
PubMed1999

A comparison of two dosing regimens of intravaginal misoprostol for second-trimester pregnancy termination.

OBJECTIVE: To compare the effectiveness of misoprostol administered intravaginally every 6 versus every 12 hours for termination of second-trimester pregnancies. METHODS: One hundred pregnant women at 12-22 weeks' gestation were randomized to receive 200 microg of misoprostol intravaginally either every 6 or every 12 hours for up to 48 hours. RESULTS: The incidences of abortion within 48 hours after initial drug administration were 87.2 and 89.2%, the complete abortion rates 43.9 and 33.3%, and the mean abortion intervals 13.8 and 14.0 hours in the 6- and 12-hour groups, respectively. Side effects were similar between groups. CONCLUSION: Misoprostol administered vaginally is effective for terminating second-trimester pregnancies. Shortening the dosing interval from 12 to 6 hours produced no significant benefit.

Abortifacient Agents, Nonsteroidal↗
PubMed2004

Vaginal misoprostol 800 microg every 12 h for second-trimester abortion.

The objective of the study was to evaluate the efficacy and safety of 800 microg misoprostol every 12 h, up to three doses, for pharmacological second-trimester abortion. The misoprostol doses were always administered by doctors into the vagina. Two-hundred and sixty-nine women with gestations within 12 and 20 weeks were recruited into the study. The main outcomes measured were successful abortion (passage of fetus and placenta without surgery), side effects and mean drop in hemoglobin, vaginal bleeding and mean time of return of menstruation. Complete abortion occurred in 245/269 (91.1%, 95% confidence interval 87-94%) patients. Vaginal bleeding lasted 15.7 +/- 4.1 days. The mean drop in hemoglobin, calculated 24 h after abortion, were statistically significant (p = 0.0001), as also was the mean hemoglobin measured 14 days after abortion, but without clinical relevance. According to the results obtained, 800 microg of misoprostol administered every 12 h, up to a maximum of three doses, could be a valid method for abortion within 12 and 20 weeks of gestation.

Abortion, Induced↗
PubMed1989

Long-term treatment of leiomyomas with gestrinone.

A prospective randomized study was conducted in 100 women with leiomyomas in order to evaluate the effect of gestrinone, a synthetic derivative of ethynil-nor-testosterone. Patients in group A received capsules containing 2.5 mg of gestrinone three times weekly orally. Those in group B received capsules containing 5.0 mg twice weekly, also orally. In group C, patients used by vaginal route tablets containing 5 mg of gestrinone three times weekly. Reduction in uterine volume occurred in all three groups of patients. Of patients who discontinued treatment at 6 months, uterine volume remained lower than pretreatment values in 89%, 18 months after discontinuation. Of those patients who discontinued at 1 year, uterine volume remained below pretreatment levels in 76% 1 year after discontinuation. In patients treated continuously for 24 months, mean uterine volume decreased from a mean 339 cm3 to 273 cm3, a statistically significant difference. The vaginal route showed statistically more significant volume decreases than the oral route for all treatment intervals.

Administration, Intravaginal↗
PubMed2003

Local estrogen treatment in patients with urogenital symptoms.

OBJECTIVES: Determination of the efficacy and safety of vaginally administered low dose (25 microg) micronized 17beta-estradiol in the management of patients with urogenital symptoms. METHODS: A total of 1612 patients with urogenital complaints were randomized to receive 25 microg of micronized 17beta-estradiol (n=828) or placebo (n=784) in a multicenter double-blind placebo-controlled study running for 12 months. Female patients were treated once a day over a period of 2 weeks, and then twice a week for the remaining of the 12 months with an active or placebo tablet. The assessment included full history-questionnaire, micturition diary, gynecologic and cystometric examination, transvaginal ultrasound, and serum 17beta-estradiol level determination. It was carried out at the beginning, and after 4 and 12 months of treatment. RESULTS: The overall success rate of micronized 17beta-estradiol and placebo on subjective and objective symptoms of postmenopausal women with vaginal atrophy was 85.5%, and 41.4%, respectively. A significant improvement of urinary atrophy symptoms was determined in vaginal ERT group as compared with the beginning of the study (51.9% vs. 15.5%, P=0.001). The maximal cystometric capacity (290 ml vs. 200 ml, P=0.023), the volume of the urinary bladder at which patients first felt urgency (180 vs. 140, P=0.048), and strong desire to void (170 ml vs. 130 ml, P=0.045) were significantly increased subsequent to the micronized 17beta-estradiol treatment. The number of patients with uninhibited bladder contractions significantly decreased following micronized 17beta-estradiol as compared with pretreatment values (17/30, P=0.013). Side effects were observed in 61 (7.8%) patients treated with low dose micronized 17beta-estradiol. Therapy with 25 microg of micronized 17beta-estradiol did not raise serum estrogen level nor stimulated endometrial growth. CONCLUSIONS: Local administration of 25 microg of micronized 17beta-estradiol is an effective and a safe treatment option in the management of women with urogenital complaints.

Administration, Intravaginal↗
PubMed2003

Efficacy and tolerability of a novel estradiol vaginal ring for relief of menopausal symptoms.

OBJECTIVE: To assess the efficacy, tolerability, and acceptance of a vaginal ring delivering the equivalent of 50 or 100 microg per day of estradiol (E2), compared with placebo, for relief of moderate to severe vasomotor symptoms and urogenital symptoms in postmenopausal women. METHODS: Women with moderate to severe vasomotor symptoms (seven or more per day or 56 per week average) received 13 weeks of treatment with a vaginal ring delivering 50 microg per day E2 (n = 113) or 100 microg per day E2 (n = 112), or a placebo vaginal ring (n = 108). Severity of vasomotor symptoms was assessed by a daily diary card and the Greene Climacteric Scale. Urogenital signs and symptoms were evaluated via patient and physician assessment and vaginal cytology. Participant satisfaction with the vaginal ring was evaluated via questionnaire. RESULTS: Vasomotor symptoms significantly improved in both treatment groups, compared with placebo (P <.05). There was a trend toward greater improvement in patient assessment of urogenital signs with active rings compared with placebo. For women with vaginal atrophy at baseline (n = 60), the maturation index improved significantly in both treatment groups compared with placebo. Total Greene Climacteric Scale scores significantly improved for both E2 vaginal ring groups (P <.05) compared with placebo. The vaginal rings were well tolerated. Most adverse events were mild or moderate and consistent with estrogen therapy. CONCLUSION: A novel vaginal ring delivering the equivalent of 50 or 100 microg per day of E2 significantly reduced the number and severity of vasomotor symptoms and improved urogenital symptoms, compared with placebo. The E2 vaginal ring was well tolerated.

Administration, Intravaginal↗
PubMed2002

Twice-weekly transdermal estradiol and vaginal progesterone as continuous combined hormone replacement therapy in postmenopausal women: a 1-year prospective study.

OBJECTIVE: The purpose of this study was to evaluate the acceptability and endometrial safety of a twice-weekly administration of transdermal estradiol (0.05 mg) systems and vaginal progesterone gel (Crinone [Serono, Rome, Italy] 4%, 45 mg/d) as a continuous combined nonoral hormone replacement therapy regimen. STUDY DESIGN: Thirty-five postmenopausal women took part in this 1-year prospective observational trial. The bleeding pattern, blood pressure, weight, endometrial thickness, and endometrial histologic characteristics of the women were monitored. Mean values were compared before and after treatment by paired Student t tests. RESULTS: Twenty-six (74.3%) women completed the study and were totally amenorrheic. A total of 350 cycles yielded valuable data. Of these, 287 (82%) cycles were amenorrheic. At month 3, blood pressure and weight decreased significantly. At final assessment, endometrial thickness was significantly greater than baseline (4.6 +/- 0.9 vs 3.6 +/- 0.9 mm; P <.0005), and histologic examination revealed endometrial atrophy in 24 (92.3%) cases and signs of decidualization in 2 cases. CONCLUSION: Transdermal estradiol and a twice-weekly administration of the vaginal progesterone gel Crinone constitutes a new, viable hormone replacement therapy regimen. It represents a practical option for a no-bleed treatment, ensuring both high endometrial protection and the inherent safety linked to administrating physiologic hormones nonorally.

Administration, Cutaneous↗
PubMedDate not supplied

Quantitative and qualitative assessment of milk production after pharmaceutical induction of lactation in the mare.

The induction of lactation is performed in ruminants by steroidogenic impregnation, followed by drugs intended to increase prolactin secretion. The aim of this study was to induce lactation in barren mares and to evaluate milk production. Five treated and 5 control mares were used in June and September in year 1, and 12 mares were used in year 2. Mares were administered a vaginal pessary (500 mg altrenogest and 50 mg estradiol benzoate) for 1 week. The 2nd week, another sponge with 100 mg estradiol benzoate was administered, together with 50 mg/100 kg body weight (BW) sulpiride in oil (IM q12h). All mares were milked by hand. Drug treatment was stopped after I L was obtained. Milk production and composition and plasma prolactin concentration were measured. In year 2, the same steroid treatment was applied, but mares received sulpiride (n = 6) or domperidone (1.1 mg/kg PO q12h) (n = 6). A milking machine and oxytocin injections 1 minute before the start of milking were used. In year 1, all treated mares started milking within 1-5 days after sulpiride treatment. Mean daily milk production was 0.88 +/- 0.52 L/500 kg BW. Milk immunoglobulin G (IgG) contents increased in all mares (IgG concentration range, 14-92 g/L). Plasma prolactin increased during sulpiride treatment (range. 27.7 +/- 2.9 to 43.7 +/- 6.7 ng/mL [before] to 289.0 +/- 7.8 ng/mL during treatment, P < .001). In year 2, results were similar to those in year 1, with peak IgG concentrations ranging from 4.2 to 106.7 g/L and a larger daily milk production (3.13 +/- 0.75 with sulpiride and 3.45 +/- 0.51 L/500 kg BW with domperidone). In conclusion, lactation can be induced in mares within 2 weeks, and some mares produce good-quality colostrum.

Administration, Intravaginal↗
PubMed1997

Patterns of uterine activity. Using oxytocin after intracervical PGE2.

OBJECTIVE: To compare patterns of uterine activity from low-dose oxytocin begun immediately or six hours after intracervical placement of prostaglandin E2 (PGE2) gel for the induction of labor. STUDY DESIGN: A total of 50 nonlaboring women at term with an unfavorable cervix (Bishop score < or = 4) were given a 0.5-mg dose of PGE2 gel. Each was then randomized either to be observed or to receive a low dose of oxytocin (2 mU/min, increased by 2 mU/min at 30-minute intervals, as necessary). After the six-hour observation, the patient was reexamined, and a low dose of oxytocin was either begun or continued. An adequate sample size (21 per group) was calculated for evaluating uterine activity changes. Comparisons were made using chi 2 testing, Student's t test and analysis of variance, as appropriate. RESULTS: There were no differences between the two groups in maternal race, gestational age, predose Bishop score, predose uterine activity or indication for induction. Uterine contractions became more frequent (P < .01) and were judged to be more intense (P < .02) and earlier when oxytocin was used immediately after PGE2 placement. No uterine hyperstimulation or abnormal fetal heart rate pattern was observed that required discontinuation of the oxytocin. The percentages of cases delivering vaginally within 24, 36 and 48 hours were greater when oxytocin was begun immediately in nullipara (P < .01). CONCLUSION: Low-dose oxytocin may be started immediately after instilling intracervical PGE2, with shortened time until the onset of adequate contractions.

Administration, Intravaginal↗