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PubMed1987

Systemic concentrations of metronidazole and its main metabolites after intravenous oral and vaginal administration.

Metronidazole kinetics was studied in 5 healthy women after a single dose given intravenously, orally or vaginally, 500, 400 and 500 mg, respectively. Serum levels of the drug and of its hydroxy and acid metabolites were assessed. The results after intravenous and oral boluses were consistent with previous reports. After vaginal dose maximum serum levels of about 1 microgram/ml of the drug were obtained between 9 and 24 h after the dose. Maximum concentration of the hydroxy metabolite was about 0.3 microgram/ml after 24 h. Bioavailability of the drug was 19 +/- 3% after the vaginal dose as compared to 100 +/- 5% after the oral dose. Daily insertion into the vagina of 500 mg metronidazole resulted in a maximum serum concentration of 1.2 +/- 0.2 microgram/ml of the parent drug and of 0.6 +/- 0.1 microgram/ml of the hydroxy metabolite after about 3 days (range 2-4) after which no accumulation was noted. Urinary excretion of the metabolites was considerably lower after vaginal than after intravenous or oral administration, but the proportion between the two metabolites in the urine was constant.

Administration, Intravaginal↗
PubMed1978

Pathology of experimental Histophilus ovis infection in sheep. II. Pregnant ewes.

Intravenous inoculation of Histophilus ovis to pregnant ewes at mid or late gestation resulted in acute bacterial endometritis, placentitis and foetal death. There were no lesions in the foetuses but H. ovis was recovered from the uteri of the ewes and the placentas. Oral or intravaginal administration had no effect.

Abortion, Veterinary↗
PubMed1991

Comparative study of fluconazole and clotrimazole in the treatment of vulvovaginal candidiasis.

Fluconazole is a new oral triazole antifungal with good activity against Candida spp. In this study, we investigated the effectiveness and tolerability of a three-day course of treatment with fluconazole compared with clotrimazole vaginal tablets in nonpregnant women with acute Candida vaginitis. Of the 90 evaluable patients who received fluconazole, 76 (84 percent) were asymptomatic seven to ten days after treatment compared with 84 of 95 (88 percent) treated with clotrimazole. An additional ten patients in the fluconazole group (11 percent) and seven in the clotrimazole group (7 percent) had improvement in their signs and symptoms. Only four patients in each group (4 percent) were considered treatment failures. Mycological cures were obtained in 89 and 93 percent of patients treated with fluconazole and clotrimazole, respectively, seven to ten days posttreatment. Clinical cure rates remained high one month posttreatment: 79 percent in the fluconazole group and 83 percent in the clotrimazole group. Both therapies were well tolerated. One patient discontinued treatment after she developed diarrhea while receiving fluconazole. The most common adverse effects associated with fluconazole use were nausea (six percent) and diarrhea (three percent). No clinically significant laboratory abnormalities were observed. In this investigation, oral fluconazole therapy was found to be as safe and effective as clotrimazole vaginal tablets in women with acute vulvovaginal candidiasis.

Administration, Intravaginal↗
PubMed2002

The effects of short-term medroxyprogesterone acetate and micronized progesterone on glucose metabolism and lipid profiles in patients with polycystic ovary syndrome: a prospective randomized study.

In this prospective, randomized study we determined 10-d effects of medroxyprogesterone acetate (MPA) and micronized progesterone (MP) either orally or per vaginally on hormonal parameters, glucose metabolism and lipid profiles in patients with polycystic ovary syndrome (PCOS). Twenty-eight consecutive women with PCOS were randomized to receive 10-d MPA, oral MP, or vaginal MP. Hormonal parameters, insulin levels, oral glucose tolerance test, lipid profiles, and homeostasis model assessment and quantitative insulin sensitivity check indexes were assessed in all groups before and after treatment. Oral MPA and oral MP decreased LH (15.64 +/- 13.17 to 7.27 +/- 4.35 IU/liter, P = 0.028, and 18.85 +/- 11.86 to 10.49 +/- 6.48 IU/liter, P = 0.009, respectively) and total testosterone (5.85 +/- 2.80 to 3.40 +/- 1.72 nmol/liter, P = 0.013, and 5.29 +/- 2.98 to 3.43 +/- 2.10 nmol/liter, P = 0.037, respectively) levels. Hormonal parameters did not change with vaginal MP. Basal insulin (123.42 +/- 97.50 to 87.38 +/- 48.68 pmol/liter; P = 0.021) and homeostasis model assessment levels decreased, and quantitative insulin sensitivity check index increased significantly in the oral MPA group. Low density lipoprotein cholesterol and lipoprotein (a) levels decreased only in the MPA group. In conclusion, short-term oral MP and especially oral MPA might ameliorate insulin sensitivity in patients with PCOS. Vaginal MP has no effect on glucose metabolism and lipid profiles. LH, total testosterone, and insulin levels may be affected from the short-term progesterone treatment.

Administration, Intravaginal↗
PubMed2004

Mucosal drug delivery: membranes, methodologies, and applications.

In recent years, extensive research into novel forms of drug delivery has suggested that mucosal approaches offer a promising therapeutic alternative, especially for systemically acting drugs. Transmucosal drug delivery offers many benefits, including noninvasive administration, convenience, rapid onset, as well as elimination of hepatic first-pass metabolism. The investigated absorptive surfaces consist of the nasal, buccal, ocular, vaginal, and rectal mucosae. Among these, the nasal and buccal routes have proved the most promising to date. The bioavailability achieved mainly depends upon the pathophysiological state of the mucosa and the properties of both the drug and delivery systems. Various agents can increase the efficacy of transmucosal drug delivery. These include cyclodextrins, bile salts, surfactants, fusidic acid derivatives, microspheres, liposomes, and bioadhesive agents. The mechanisms of action, effectiveness, and toxicity profiles of these enhancers have been investigated extensively in both animal and human models.

Absorption↗
PubMed2006

Efficacy in treatment of cervical HRHPV infection by combination of beta interferon, and herbal therapy in woman with different cervical lesions.

Cervical dysplasia, a premalignant lesion that can progress to cervical cancer, is caused primarily by a sexually transmitted infection with an oncogenic strain of the human papillomavirus (HPV). The HPV infections are treated through destroying the clinical lesions: laser, cryotherapy, podophyllin... The hope is that by causing local tissue inflammation that the body will be stimulated to mount an antibody response and thereby prevent recurrence. In contrast to other prevention approaches, vaccines can reduce susceptibility in uninfected partners by stimulating the immune system. Aloe vera has also been reported to retard tumour growth and stimulate the immune response to viruses. A list of possible actions of propolis includes: antibacterial, antifungal, antiviral, antioxidant, anticarcinogenic, antithrombotic and immunomodulatory. Research on the possible role of some B vitamins in preventing cancer began in the last few decades, but however this complex have an influence on immune status. The aim of our study is to try to treat the HPV infection as confirmed cause of neoplastic transformation with some herbal therapy and interferon and to try define the guidelines in the management of the HPV positive patients. Goal of this paper is to search for evidence of efficacy of any treatment for HPV infection of the cervix mostly in woman with no concomitant CIN. Fifty five woman affected by HPV genital infection were enrolled in the study from September 2005 to April 2006. Patients were classified according to the results of the HPV testing prior and after the therapy. Patients were randomized into two groups: the first group was HPV positive woman treated with other than recommended therapy (n=20), (control group); the second group was pharmacologically treated with intravaginal administration of an interferon and aloe vera-propolis in recommended scheme (n=35) with treatment of the possible fungal or bacterial genital infection prior to the specific therapy. The almost same therapy was recommended to the male partner. Patients from the second group used B complex during the therapy. Patients were retested for the HPV presence after three or six month from therapy depend of the presence bacterial or fungal genital coinfection. Three months after applied therapy HPV infection was still present in more than 90% of the patients in the first group. In the second group treated according to the recommended therapy scheme HPV infection disappeared in 71.42% of the patients after three months and in 100% of patients after six months. Samples of the cervical smear for the HPV analysis were being taken during routine gynecological examinations, by using sticks with cotton, taken from the Digene Specimen Collection Kit, from the whole surface of a portion, and by mild rotating moves from the outer cervical entrance. Our results suggest that the combination of interferon and herbal therapy with B complex is effective, atraumatic and simple non-surgical treatment of HPV infection. Since prospective efficacy trials will take several years to complete, considering alternative approaches is also worthwhile.

Aloe↗
PubMed2003

Report from the Faculty of Family Planning and Reproductive Health Care AGM, May 2003: Medical termination of pregnancy in the late first trimester.

In the UK, mifepristone and gemeprost are licensed for medical termination of pregnancy (TOP) in the first trimester up to 63 days' amenorrhoea. Current practice, however, is to use low-dose (200 mg) mifepristone and misoprostol. We report a large cohort study using these drugs for medical TOP in the first trimester after 63 days amenorrhoea. Of 415 patients undergoing the procedure, 392 (95%) aborted completely and 96% required only two doses of misoprostol. We conclude that the regime is effective with few complications, however certain safeguards may be necessary for its widespread introduction

Abortifacient Agents, Nonsteroidal↗
PubMed1988

Clinical pharmacokinetics of ketoconazole.

Ketoconazole, a synthetic imidazole antifungal, is effective for superficial fungal infections, genital candidosis and chronic mucocutaneous candidosis, and has been used in immunocompromised patients and advanced prostatic carcinoma. Absorption of ketoconazole is variable after oral administration, with large variability in peak serum concentrations. Antacids reduce, and food or dilute hydrochloric acid increase, absorption. Renal failure and bone marrow transplantation are associated with reduced absorption. Ketoconazole is not absorbed systemically after topical administration, and minimally absorbed from the vagina. Distribution of ketoconazole varies according to the tissue sampled, the underlying disease and the dose and duration of treatment. Ketoconazole does not cross the intact blood-brain barrier, and crosses to only a limited extent in fungal meningitis. Urinary concentrations of ketoconazole are usually low, but vaginal and vaginal tissue concentrations correlate with those in serum. Seminal fluid concentrations are inadequate for treatment of epididymitis. Ketoconazole is 83.7% plasma protein (mainly albumin) bound, and 15.3% is erythrocyte bound, resulting in only 1% of free drug. Animal studies indicate strong binding to the cytochrome P-450 mono-oxygenase complex. Extensive metabolism to inactive metabolites occurs, the products being mainly excreted in the faeces. Saturable hepatic first-pass metabolism is probable. The half-life of ketoconazole is dose-dependent, increases during long term treatment, suggesting auto-inhibition of metabolism. The kinetics after oral administration fit a 2-compartment model. Drug interactions of theoretical, if not practical, significance include warfarin, chlordiazepoxide, methylprednisolone, cyclosporin and drugs known to induce microsomal enzymes. In each case, some dosage adjustment for ketoconazole, or the interacting drug, may be required.

Administration, Intravaginal↗
PubMed2004

Clinical development of microbicides for the prevention of HIV infection.

The HIV/AIDS pandemic continues its spread at a rate of over 15,000 new infections every day. Sexual transmission of HIV-1 is the dominant mode of this pandemic spread. For the first time since the disease emerged in the early 1980s, about half the 42 million people now living with HIV/AIDS worldwide are women. Worldwide, more than 90 percent of all adolescent and adult HIV infections have resulted from heterosexual intercourse. The "feminization" of the pandemic largely driven by the social, economic, and biological factors warrants urgent attention particularly for the adolescent female population. In the absence of an effective prophylactic anti-HIV therapy or vaccine, current efforts are aimed at developing intravaginal/intrarectal topical formulations of anti-HIV agents or microbicides to curb the mucosal and perinatal HIV transmission. Microbicides would provide protection by directly inactivating HIV or preventing HIV from attaching, entering or replicating in susceptible target cells as well as dissemination from target cells present in semen or the host cells that line the vaginal/rectal wall. Thus, ideally, anti-HIV microbicides should be capable of attacking HIV from different angles. In addition, a contraceptive microbicide could help prevent unintended pregnancies worldwide. To be a microbicide, these agents must be safe, effective following vaginal or rectal administration, and should cause minimal or no genital symptoms following long-term repeated usage. A safe and efficacious anti-HIV microbicide is not yet available despite the fact that more than 60 candidate agents have been identified to have in vitro activity against HIV, 18 of which have advanced to clinical testing. Targeting HIV entry has been a favored approach because it is the first step in the process of infection and several readily available anionic polymeric products seem to variably interfere with these processes are the primary candidates for potential microbicides. Formulations of some anionic polymeric antiviral agents have been tested at various doses and various durations for safety, tolerability, and acceptability in Phase I/II clinical trials (vaginal, rectal, or penile studies) in HIV-uninfected and/or HIV-infected populations. Current multicenter Phase I/II safety and Phase II/III efficacy studies that are being conducted or planned in different geographical locations by various special interest groups are designed for rapid clinical development of candidate products. The currently marketed detergent-type spermicide, nonoxynol-9 (N-9), has failed in Phase III clinical trials, due to the drug-induced formation of localized genital lesions that might in fact actually promote virus transmission. Alternative "first-generation" microbicides that have undergone Phase I/II safety and tolerability studies in HIV-uninfected and/or HIV-infected volunteers include polymeric viral fusion inhibitors (dextrin sulfate/Emmelle, carrageenans [PC-213, PC-503, PC-515/Carraguard], cellulose sulfate/Ushercell, polystyrene sulfonate, naphthalene sulfonate [PIC 024-4/PRO 2000/5], acidifying gel [Carbomer 974P/BufferGel], Lactobacillus (L. crispatus) suppository/CTV-05, detergent-type dual-function barriers [ACIDFORM, GEDA Plus, SURETE, Glyminox/C31G/Savvy, Invisible Condom], herbal extracts [Praneem], and viral replication inhibitors [PMPA/Tenofovir]. For majority of these products, no information is available regarding their long-term mucosal safety, carcinogenicity potential, bioavailability, or efficacy following their extended vaginal or rectal exposure. The irritative genitourinary symptoms reported for a number of these first-generation products in Phase I clinical trials implies that the "soft" preclinical endpoints for mucosal safety established for the use and development of vaginal spermicides may not be rigorous enough for vaginal and rectal microbicides because of the efficient sexual tra virus diversity, and genetic environment. It is now apparent that sexually transmitted R5 HIV-1 viruses have less positive charge on their surface compared with the R4 HIV-1 viruses, which may limit the anionic polymers as topical microbicides despite extensive clinical trials. Nevertheless, their ongoing clinical trials, reviewed here, using optimized formulations, and special populations in various geographic locations are paving the way for future rigorous clinical testing of "mechanism-based" broad-spectrum anti-HIV microbicides that are currently under intense development. It is anticipated that future microbicide trials will focus on combination of products capable of attacking HIV life cycle at multiple steps intended to increase efficacy, limit cross-resistance as well as minimize microbicide-induced host toxicity.

Administration, Intravaginal↗
PubMed2002

Sodium lauryl sulfate, a microbicide effective against enveloped and nonenveloped viruses.

The number of individuals infected with human immunodeficiency virus (HIV) and other pathogens causing sexually transmitted diseases (STDs) is growing dramatically worldwide. Globally, heterosexual transmission may account for as much as 85-90% of new cases of HIV infection. Latex condoms represent an effective barrier against sexually transmitted pathogens, but unfortunately, their use is not generalized. Therefore, there is an urgent need to develop safe and potent topical microbicides under the control of women to efficiently reduce the spread of sexually transmitted infections. Sodium lauryl sulfate (SLS), an anionic surfactant with protein denaturing potency, is a potent inhibitor of the infectivity of several enveloped (Herpes simplex viruses, HIV-1, Semliki Forest virus) and nonenveloped (papillomaviruses, reovirus, rotavirus and poliovirus) viruses. The mechanism of action of SLS involves the solubilization of the viral envelope and/or the denaturation of envelope and/or capsid proteins. Studies have shown that SLS is not toxic for cultured cell lines of different origins at concentrations that inactivate HIV-1, herpes and human papillomavirus in vitro. In addition, intravaginal pretreatment of mice with a gel formulation containing SLS, completely protected animals against Herpes simplex virus type-2 infection. The gel formulation containing SLS was also well-tolerated following repeated intravaginal administrations to rabbits. Taken together, these data suggest that SLS represents a potential candidate for the use as a topical microbicide to prevent the sexual transmission of HIV-1, herpes, human papillomavirus and possibly other sexually transmitted pathogens. The impact of such a preventive tool on public health can be enormous.

Animals↗
PubMed2006

[Medicamentous abortion with mifepristone and misoprostol in Serbia and Montenegro].

BACKGROUND/AIM: Medicamentous abortion was first introduced in Serbia and Montenegro in September 2001. The aim of this study was to assess the efficiency, side effects, and acceptability of medicamentous abortion using mifeprostone orally (600 mg), and 48 hours later, misoprostol both orally and vaginally in different regiments in our population (400 mcg, 600 mcg, 800 mcg). METHODS: A total of 235 consecutive women with pregnancies up to 49 days of gestational age were assigned to 4 groups according to the different misoprostol regiment (group I 400 mcg, group II 600 mcg, group III 800 mcg orally, and group IV 800 mcg both orally and vaginally). The principal outcome measure was a successful abortion defined as a complete expulsion of intrauterine contents without a need for surgical intervention 14 days after the procedure. Other outcome measures were the following: drug related effects, and adverse effects related to the abortion process. RESULTS: In general, the success rate was 50%, 89.48%, 75% and 92.11% in the groups I, II, III, and IV, respectively, as judged by the complete expulsion of the intrauterine contents without surgical intervention (t1:4 = 7.005; t2:4 = 0.3872, t3:4 = 2.9784, p < 0.01). The incidence of adverse effects (vomiting, abdominal pain, bleeding, and fever) was low in general, but among our groups it occurred mostly with the higher doses of orally applied misoprostol (800 and 600 mcg). Only one case required urgent curettage for heavy vaginal bleeding, and two blood transfusions, as well. No cases of intact pregnancies were recorded in the study. CONCLUSION: Our study showed that a mifepristone dose of 600 mg orally, and misoprostol 400 mcg orally and 400 mcg vaginally were most effective. Thus, a combination of mifepristone and misoprostol for medicamentous abortion should take a higher proportion in the termination of early pregnancy in our population.

Abortifacient Agents, Nonsteroidal↗
PubMed1991

Treatment of candidal vaginitis. A prospective randomized investigator-blind multicenter study comparing topically applied econazole with oral fluconazole.

Two hundred and thirty-five women with clinically and microbiologically proven candidal vaginitis were randomly allocated for treatment with either one topically applied vaginal tablet of 150 mg econazole (114 women) or one orally administered capsule of 150 mg fluconazole (121 women). The women returned for follow-up visits 7-10, 28-35, and 80-100 days after the recruitment visit. Women with clinical and/or mycological failures and/or a recurrence were successively excluded from the follow-up. At the 28-35-day follow-up visit, the women treated with fluconazole had a significantly higher clinical/microbiological cure rate than those given econazole (P = 0.022; Fisher's exact 2-tail test). No significant such differences were observed at the 7-10 and the 80-100-day follow-up visits, although fluconazole tended to be more efficacious. Nine women administered fluconazole, and 2 women given econazole reported minor systemic side effects of the treatment. Three women out of 4 preferred oral to local therapy of candidal vaginitis.

Administration, Intravaginal↗
PubMed1996

Effect of progesterone and its 5 alpha and 5 beta metabolites on symptoms of premenstrual syndrome according to route of administration.

Orally administered progesterone may have advantages over other routes of administration in the treatment of premenstrual syndrome (PMS) because of substantially higher levels of the anxiolytic metabolites 5 alpha and 5 beta pregnanolone. The only previous placebo-controlled trial which used oral progesterone reported beneficial effects in the treatment of PMS. The present study, a double-blind crossover trial, compared the administration of 300 mg daily oral progesterone with 200 mg daily vaginal progesterone and matched placebos for 10 days premenstrually. Although there was a significant treatment effect on symptoms, no difference between active treatments and placebo was found. The trial was terminated with 25 women completing treatment as it was evident that no clinically significant effect of either form of progesterone was likely to be detected even with twice the sample size. Serum levels of progesterone and metabolites showed that oral administration resulted in supraphysiological levels of 5 alpha and 5 beta metabolites and there was a negative correlation between 5 alpha pregnanolone levels and anxiety. However, this did not translate to overall reduction in premenstrual distress or anxiety beyond that achieved by placebo, as measured by validated questionnaires.

Administration, Intravaginal↗
PubMed1992

Vaginal bromocriptine--clinical and biochemical effects.

Adverse effects occur in over 50% of women taking oral bromocriptine, causing at least 10% to discontinue treatment. Although the drug is absorbed from the vagina and reportedly caused no side-effects in one patient intolerant of oral bromocriptine, long-term clinical effects of daily vaginal administration have not been assessed. We have now given bromocriptine vaginally for up to 2 years to 31 hyperprolactinemic and five normoprolactinemic women, 17 of whom were intolerant of oral bromocriptine. The drug was well absorbed from the vagina and a daily dosage of 2.5 mg lowered serum prolactin levels in 28 of the hyperprolactinemic women (in 11 to within normal limits), restored menstrual cyclicity, and abolished galactorrhea; one of the four infertile women conceived. Minor side-effects occurred in only three women. Vaginal administration is clinically effective, avoids the adverse effects of oral therapy and could be the first-line treatment for patients requiring bromocriptine.

Administration, Intravaginal↗
PubMed2002

Differential induction of mucosal and systemic antibody responses in women after nasal, rectal, or vaginal immunization: influence of the menstrual cycle.

A cholera vaccine containing killed vibrios and cholera toxin B subunit (CTB) was used to compare mucosal immunization routes for induction of systemic and mucosal Ab. Four groups of women were given three monthly immunizations by the rectal immunization (R(imm)) route, nasal immunization (N(imm)) route, or vaginal immunization route during either the follicular (V-FP(imm)) or luteal (V-LP(imm)) menstrual cycle phase. N(imm) was performed with 10-fold less vaccine to determine if administration of less Ag by this route can, as in rodents, produce mucosal Ab responses comparable to those induced by higher dose R(imm) or vaginal immunization. Concentrations of Ab induced in sera and secretions were measured by ELISA. None of these routes produced durable salivary Ab responses. N(imm) induced greatest levels of CTB-specific IgG in sera. R(imm) failed to generate CTB-specific IgA in genital tract secretions. N(imm), V-FP(imm), and V-LP(imm) all produced cervical CTB-specific IgA responses comparable in magnitude and frequency. However, only V-FP(imm) induced cervical IgA2-restricted Ab to the bacterial LPS vaccine component. V-FP(imm), but not V-LP(imm), also induced CTB-specific IgA in rectal secretions. N(imm) was superior to V-FP(imm) for producing rectal CTB-specific IgA, but the greatest amounts of CTB-specific IgA and LPS-specific IgA, IgG, and IgM Ab were found in rectal secretions of R(imm) women. These data suggest that in women, N(imm) alone could induce specific Ab in serum, the genital tract, and rectum. However, induction of genital tract and rectal Ab responses of the magnitude generated by local V-FP(imm) or R(imm) will likely require administration of comparably high nasal vaccine dosages.

Administration, Intranasal↗