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1.
Journal of Menopausal Medicine ; : 63-68, 2019.
Article in English | WPRIM | ID: wpr-765756

ABSTRACT

OBJECTIVES: Although vaginal estrogen is highly effective in alleviating genitourinary symptoms of menopause (GSM), some women are reluctant to use hormonal treatment. Our aim was to evaluate the effect of a zinc-containing vaginal moisturizer gel on GSM. METHODS: Women with GSM were enrolled. Patients were asked to use the vaginal gel daily for 2 weeks. Vaginal Health Index (VHI) was calculated. Visual analogue scale (VAS) was obtained on vaginal pain, dryness, burning, itching, dyspareunia and dysuria before and 2 weeks after the completion of treatment. Vaginal cytology was obtained. Vulvovaginal symptom questionnaire (VSQ-21) was used to assess subjective symptoms. RESULTS: Thirty-seven women with GSM participated in the study. The VHI improved significantly (mean ± standard deviation, 13 ± 4 before vs. 17 ± 4 after treatment, P < 0.01). The patient reported VAS combined score was significantly lower after the treatment (18 ± 14 before vs. 7 ± 12 after treatment, P < 0.01). The largest improvement occurred in vaginal dryness. The maturation value did not change significantly. There were no signs of inflammation on vaginal cytology. VSQ-21 combined scores also improved significantly (7.9 ± 5.5 before vs. 2.7 ± 3.6 after the intervention, P < 0.01). Side effects were rare and minor. CONCLUSIONS: Novel zinc-containing vaginal moisturizer gel significantly improves postmenopausal vulvovaginal symptoms without serious side effects.


Subject(s)
Female , Humans , Burns , Dyspareunia , Dysuria , Estrogens , Inflammation , Menopause , Pilot Projects , Pruritus , Vagina , Vaginal Creams, Foams, and Jellies , Zinc
2.
Journal of Menopausal Medicine ; : 1-10, 2018.
Article in English | WPRIM | ID: wpr-765732

ABSTRACT

OBJECTIVES: Atrophic vaginitis (AV), which is common in postmenopausal women, is characterized by vaginal dryness, dyspareunia, and discomfort. There are a variety of therapeutic agents for the treatment of AV, besides hormone replacement therapy. We performed this systematic review to compare the effectiveness of various therapies for symptom improvement in AV patients. METHODS: We searched the Cochrane Library, EMBASE, MEDLINE, and other literature (Google Scholar, Web of Science, and hand search) for studies published between January 2010 and March 2015. AV was evaluated by the following outcomes: vaginal pH, dyspareunia, vaginal dryness, or cytological change (endometrial thickness, percentages of superficial cells and parabasal cells). They measured treatment efficacy with various outcomes pertaining to AV symptoms. RESULTS: Meta-analysis suggested that ospemifene was effective against dyspareunia, vaginal dryness, endometrial thickness, and percentage changes in superficial and parabasal cells. Vaginal pH was most affected by soy isoflavone vaginal gel. Ospemifene was effective for AV symptoms. CONCLUSIONS: This systematic review compared the effects of several therapeutic agents on symptoms of AV through a network meta-analysis. This study provides objective evidence for clinical treatment and efficacy management in AV.


Subject(s)
Female , Humans , Atrophic Vaginitis , Dyspareunia , Hand , Hormone Replacement Therapy , Hydrogen-Ion Concentration , Postmenopause , Treatment Outcome , Vagina , Vaginal Creams, Foams, and Jellies
3.
IJCBNM-International Journal of Community Based Nursing and Midwifery. 2018; 6 (2): 101-110
in English | IMEMR | ID: emr-192428

ABSTRACT

Background: The present study was conducted on the effect of prangos ferulacea vaginal cream on accelerating the recovery of bacterial vaginosis


Methods: This randomized controlled clinical trial was conducted on 100 non-pregnant women referring to health centers affiliated to Lorestan University of Medical Sciences in 2016 with the diagnosis of bacterial vaginosis based on the patient's complaints, Amsel's clinical criteria, and the Nugent microscopic criteria. The women were randomly divided into two groups of 50. One group was treated with oral metronidazole plus Prangos ferulacea vaginal cream and the other with oral metronidazole plus a placebo vaginal cream for seven days. The patient's complaints, Amsel's clinical criteria and the Nugent microscopic criteria were assessed seven days after treatment. The data were analyzed using SPSS, version 20, with a significance level of 0.05


Results: The response to oral metronidazole plus Prangos ferulacea vaginal cream treatment was 94% according to Amsel's clinical criteria and 88% according to the Nugent microscopic criteria. The response to oral metronidazole plus placebo vaginal cream treatment was 94% according to Amsel's criteria and 86% according to the Nugent criteria. The analysis of the patients' complaints, Amsel's clinical criteria and the Nugent microscopic criteria showed significant differences in each group before and after the treatment


Conclusion: This trial showed that Prangos ferulacea vaginal cream accelerated the recovery of bacterial vaginosis of patients with bacterial vaginosis. It can be used effectively as a complementary treatment with oral metronidazole in cases of medication resistance and also in people wishing to use herbal remedies


Subject(s)
Humans , Female , Adolescent , Adult , Middle Aged , Metronidazole/therapeutic use , Phytotherapy , Herbal Medicine , Vagina , Vaginal Creams, Foams, and Jellies
4.
Oman Medical Journal. 2017; 32 (1): 15-19
in English | IMEMR | ID: emr-185719

ABSTRACT

Objectives: To measure the effect of vaginal estrogen cream in the treatment of vaginal atrophy in menopausal Indian women


Methods: A total of 50 menopausal women aged between 40 and 80 years old with symptoms of vaginal atrophy were selected and treated with 0.5 g vaginal estrogen cream, twice weekly for 12 weeks. The women were followed up monthly where symptom score, Genital Health Clinical Evaluation [GHCE] score, vaginal pH, and vaginal maturation index [VMI] were assessed and compared to baseline data. Any adverse events were recorded


Results: There was a significant improvement [p < 0.010] in complaints such as vaginal dryness, itching, burning, and dyspareunia at the end of the study period. The clinical improvement of these patients was reflected in a decrease in GHCE score on every visit. Vaginal pH and VMI score also showed statistically significant improvements [p < 0.010]. No side effects with the drugs used were recorded during the study period


Conclusions: Vaginal estrogen cream causes symptomatic relief in women of menopausal age in India suffering from vaginal atrophy


Subject(s)
Adult , Aged , Aged, 80 and over , Middle Aged , Women , Vaginal Creams, Foams, and Jellies , Menopause , Estrogens/administration & dosage , Prospective Studies
5.
Obstetrics & Gynecology Science ; : 405-420, 2017.
Article in English | WPRIM | ID: wpr-103249

ABSTRACT

Preterm birth (PTB) is one of the most common complications during pregnancy and it primarily accounts for neonatal mortality and numerous morbidities including long-term sequelae including cerebral palsy and developmental disability. The most effective treatment of PTB is prediction and prevention of its risks. Risk factors of PTB include history of PTB, short cervical length (CL), multiple pregnancies, ethnicity, smoking, uterine anomaly and history of curettage or cervical conization. Among these risk factors, history of PTB, and short CL are the most important predictive factors. Progesterone supplement therapy is one of the few proven effective methods to prevent PTB in women with history of spontaneous PTB and in women with short CL. There are 2 types of progesterone therapy currently used for prevention of PTB: weekly intramuscular injection of 17-alpha hydroxyprogesterone caproate and daily administration of natural micronized progesterone vaginal gel, vaginal suppository, or oral capsule. However, the efficacy of progesterone therapy to prevent PTB may vary depending on the administration route, form, dose of progesterone and indications for the treatment. This review aims to summarize the efficacy and safety of progesterone supplement therapy on prevention of PTB according to different indication, type, route, and dose of progesterone, based on the results of recent randomized trials and meta-analysis.


Subject(s)
Female , Humans , Infant , Pregnancy , Cerebral Palsy , Conization , Curettage , Developmental Disabilities , Infant Mortality , Injections, Intramuscular , Pregnancy, Multiple , Premature Birth , Progesterone , Risk Factors , Smoke , Smoking , Suppositories , Vaginal Creams, Foams, and Jellies
6.
IJPR-Iranian Journal of Pharmaceutical Research. 2016; 15 (1): 23-34
in English | IMEMR | ID: emr-177535

ABSTRACT

The present investigation was designed to formulate a natural tablet for the treatment of vaginal candidiasis in order to eliminate side effects that are caused by existing antifungal drugs. Curcumin has promising antifungal activity in comparison with the existing azole antifungal drugs. Bioadhesive curcumin vaginal tablets were prepared by direct compression with different ratios of biadhesive polymers like xanthan gum, guar gum and HPMC. Curcumin tablets were characterized by studies of friability, hardness, hydration, DSC, mucoadhesion, in vitro release and antifungal activity. DSC and FT-IR data indicate there was no interaction between the drug and the excipients and also polymer concentration has some effects on melting point of curcumin. Formulation F3 showed the best results in terms of swelling and mucoadhesion together with prolonged drug release. The antifungal activity of the Curcumin tablet has demonstrated a significant effect against Candida albicans. Hence, the study indicates the possible and effective use of curcumin bioadhesive monolithic vaginal tablet for vaginal candidiasis as a promising natural antifungal treatment


Subject(s)
Curcumin , In Vitro Techniques , Vaginal Creams, Foams, and Jellies
7.
Medical Forum Monthly. 2015; 26 (6): 6-8
in English | IMEMR | ID: emr-166531

ABSTRACT

To compare the effectiveness of prostaglandin E2 vaginal gel versus vaginal tablets for the induction of labour at term. Retrospective comparative study. This study was conducted in Gynaecology and obstetric unit B, Lady Reading Hospital Peshawar, from 1st January 2013 till 31[st] December 2014. Study population was women with singleton, term pregnancy with cephalic presentation undergoing induction of labour after 37 weeks of gestation. Prostaglandin E2 [PGE2] vaginal tablets [3 mg] or vaginal [2 mg] was administered at 6-hourly intervals, two doses administered. Main outcome measured was rate of failed induction of labour, besides failed induction in primigravida and multigravida and mode of delivery was also observed in both groups. Descriptive statistics was used to analyze the data and the results are expressed in the form of frequency and percentages. The number of patients induced with PGE2 tablet [3mg] were 39.74 % [n=503] while 60.20 [n=761] were induced with PGE2 gel [2mg]. It was observed that failed induction was more in patients induced with PGE2 tablets14.11 % [n=71] as compared to PGE2 gel 8.67% [n= 66]. Sub analysis showed failed induction was more in primigravida as compared to multigravid women. Spontaneous vaginal birth was found to be the most common mode of delivery 75.31 % [n=952]. Prostaglandin E2 vaginal gel is superior to vaginal tablets for the induction of labour


Subject(s)
Humans , Female , Vaginal Creams, Foams, and Jellies , Retrospective Studies , Labor, Obstetric , Labor, Induced , Pregnancy
8.
Braz. j. pharm. sci ; 50(4): 931-941, Oct-Dec/2014. tab, graf
Article in English | LILACS | ID: lil-741355

ABSTRACT

Rational design of vaginal drug delivery formulations requires special attention to vehicle properties that optimize vaginal coating and retention. The aim of the present work was to perform a screening of mucoadhesive vaginal gels formulated with carbomer or carrageenan in binary combination with a second polymer (carbomer, guar or xanthan gum). The gels were characterised using in vitro adhesion, spreadability and leakage potential studies, as well as rheological measurements (stress and frequency sweep tests) and the effect of dilution with simulated vaginal fluid (SVF) on spreadability. Results were analysed using analysis of variance and multiple factor analysis. The combination of polymers enhanced adhesion of both primary gelling agents, carbomer and carrageenan. From the rheological point of view all formulations presented a similar behaviour, prevalently elastic and characterised by loss tangent values well below 1. No correlation between rheological and adhesion behaviour was found. Carbomer and carrageenan gels containing the highest percentage of xanthan gum displayed good in vitro mucoadhesion and spreadability, minimal leakage potential and high resistance to dilution. The positive results obtained with carrageenan-xanthan gum-based gels can encourage the use of natural biocompatible adjuvants in the composition of vaginal products, a formulation field that is currently under the synthetic domain.


O planejamento racional de formulações para a liberação vaginal de fármacos requer atenção especial às propriedades do veículo, que otimizem o revestimento e a retenção vaginal. O objetivo do presente trabalho foi realizar uma triagem de géis vaginais mucoadesivos formulados com carbomero ou carragenina em combinação binária com um segundo polímero (carbomero, goma guár ou xantana). Os géis foram caracterizados usando estudos in vitro de aderência, espalhabilidade e potencial de vazamento, bem como medições reológicas (testes de varredura de tensão e frequência) e o efeito de diluição com fluido vaginal simulado (SVF) na espalhabilidade. Os resultados foram analisados utilizando a análise de variância e de fator múltiplo. A combinação de polímeros reforçou a adesão de ambos os agentes gelificantes primários, carbomero e carragenina. Do ponto de vista reológico todas as formulações apresentaram comportamento semelhante, predominantemente elástico e caracterizado por valores de tangente de perda bem abaixo de 1. Não se encontrou correlação entre as medições reológicas e o comportamento de adesão. Os géis de carbomero e carragenina contendo o maior porcentual de goma xantana apresentaram melhor mucoadesão e espalhabilidade, menor potencial de vazamento e maior resistência à diluição in vitro. Os resultados positivos obtidos com géis de carragenina-goma xantana podem incentivar o uso de adjuvantes biocompatíveis naturais na composição dos produtos vaginais, um campo de formulação atualmente sob o domínio de produtos sintéticos.


Subject(s)
Vaginal Creams, Foams, and Jellies/analysis , Chemistry, Pharmaceutical/methods , Rheology/methods , Straining of Liquids/classification , Drug Liberation
9.
Braz. j. med. biol. res ; 44(3): 245-252, Mar. 2011. ilus, tab
Article in English | LILACS | ID: lil-576061

ABSTRACT

A 7.4 percent vaginal extract of the Brazilian pepper tree (Schinus terebinthifolius Raddi) was compared with 0.75 percent vaginal metronidazole, both manufactured by the Hebron Laboratory, for the treatment of bacterial vaginosis, used at bedtime for 7 nights. The condition was diagnosed using the combined criteria of Amsel and Nugent in two groups of 140 and 137 women, aged between 18 and 40 years. Intention-to-treat analysis was performed. Women were excluded from the study if they presented delayed menstruation, were pregnant, were using or had used any topical or systemic medication, presented any other vaginal infections, presented hymen integrity, or if they reported any history suggestive of acute pelvic inflammatory disease. According to Amsel’s criteria separately, 29 patients (21.2 percent) treated with the extract and 87 (62.1 percent) treated with metronidazole were considered to be cured (P < 0.001). According to Nugent’s score separately, 19 women (13.9 percent) treated with the extract and 79 (56.4 percent) treated with metronidazole were considered to be cured (P < 0.001). Using the two criteria together, the so-called total cure was observed in 17 women (12.4 percent) treated with the extract and in 79 women (56.4 percent) treated with metronidazole (P < 0.001). In conclusion, the cure rate for bacterial vaginosis using a vaginal gel from a pepper tree extract was lower than the rate obtained with metronidazole gel, while side effects were infrequent and non-severe in both groups.


Subject(s)
Adult , Female , Humans , Young Adult , Anacardiaceae/chemistry , Anti-Bacterial Agents/therapeutic use , Metronidazole/therapeutic use , Plant Extracts/therapeutic use , Vaginosis, Bacterial/drug therapy , Administration, Intravaginal , Anti-Bacterial Agents/administration & dosage , Double-Blind Method , Metronidazole/administration & dosage , Phytotherapy/methods , Plant Extracts/administration & dosage , Treatment Outcome , Vaginal Creams, Foams, and Jellies
10.
The Journal of Korean Society of Menopause ; : 136-141, 2011.
Article in Korean | WPRIM | ID: wpr-92204

ABSTRACT

Because sex hormones influence the lower urinary tract, menopause can cause several urinary diseases including overactive bladder, stress urinary incontinence and recurrent urinary tract infection. However, the results of many clinical studies have indicated that menopausal hormone replacement therapy is not effective for the treatment of previous diseases, especially via the oral route. Although estrogen vaginal cream or pessary is an effective treatment for overactive bladders and can prevent recurrent urinary tract infection, its beneficial effects only last for the duration of the treatment. If patients with previous mentioned urologic disease have other local symptoms and conditions, such as atrophic vaginitis and dyspareunia, local estrogen replacement therapy will be helpful in relieving the local symptoms. However, the potential for breast cancer or return of withdrawal of bleeding, patient's age, adverse effect of systemic administration, estrogen-progesterone combination therapy, and effectiveness among other treatment modalities must be considered before a treatment decision can be made. In this article, we will review the current issues on the relationship among urinary tract and sex hormone and menopause, and the effectiveness of menopausal hormone replacement therapy for the treatment of overactive bladders, stress urinary tract incontinence and recurrent urinary tract infection.


Subject(s)
Female , Humans , Atrophic Vaginitis , Breast Neoplasms , Dyspareunia , Estrogen Replacement Therapy , Estrogens , Gonadal Steroid Hormones , Hemorrhage , Hormone Replacement Therapy , Menopause , Pessaries , Urinary Bladder , Urinary Bladder, Overactive , Urinary Incontinence , Urinary Tract , Urinary Tract Infections , Urologic Diseases , Vaginal Creams, Foams, and Jellies
11.
Rev. chil. endocrinol. diabetes ; 3(3): 208-210, jul. 2010.
Article in Spanish | LILACS | ID: lil-610321

ABSTRACT

Urogenital atrophy is characterized by dryness, inflammation, and thinning of the epithelial lining of the vagina and lower urinary tract due to estrogen decline. Local estrogen therapy if effective to relieve signs and symptoms of vaginal atrophy without causing an elevation of serum estrogen levels. Although there are no big studies addressing the safety of this type of treatment, it can be maintained over long periods to avoid annoying symptoms. Special care must be taken with women with breast cancer in whom the effective dose must be titrated to avoid an increase in serum estrogens over the levels usually observed in postmenopausal women.


Subject(s)
Humans , Female , Female Urogenital Diseases/drug therapy , Estradiol/administration & dosage , Estriol/administration & dosage , Estrogens/administration & dosage , Administration, Intravaginal , Atrophy/drug therapy , Breast Neoplasms , Climacteric , Ointments , Tablets , Vaginal Creams, Foams, and Jellies , Vagina , Vagina/pathology
12.
The Journal of Korean Society of Menopause ; : 162-169, 2010.
Article in Korean | WPRIM | ID: wpr-153597

ABSTRACT

OBJECTIVES: The aim of this study was to assess atrophic symptoms, the vaginal maturation index (VMI), and vaginal pH in postmenopausal women after use of estriol vaginal tablets for the treatment of vaginal atrophy. METHODS: In a randomized prospective study, 67 postmenopausal women were treated with 500microg estriol tablets 3 times a week for 1 week in the 1-week treatment group (n = 40) and for 2 weeks in the 2-week treatment group (n = 27). The primary endpoints were changes in the VMI, vaginal pH, and improvement in participant-reported most bothersome symptom (MBS; vaginal dryness, irritation/itching, or dyspareunia). We compared three endpoints before and after treatment in each group and between the two treatment groups. The correlation between the vaginal pH and maturation value (MV) was assessed. RESULTS: A statistically significant increase in the MV, decrease in pH, and improvement in the MBS occurred for women treated with estriol vaginal tablets in the 1- (P = 0.000, P = 0.002, and P = 0.000, respectively) and 2-week treatment groups (P = 0.000, P = 0.000, and P = 0.000, respectively). There were no significant differences between the 1- and 2-week treatment groups with respect to improvement in the VMI, vaginal pH, or MBS. The correlation between the vaginal pH and MV showed a negative linear correlation at 0, 1, and 2 weeks (P = 0.000, P = 0.000, and P = 0.011, respectively). CONCLUSION: Treatment with 500microg estriol vaginal tablets thrice-weekly for 1 week was effective in improving. It is thought that the three primary endpoints (VMI, vaginal pH, and MBS) improved at the same time during treatment.


Subject(s)
Female , Humans , Estriol , Estrogens , Hydrogen-Ion Concentration , Prospective Studies , Tablets , Vaginal Creams, Foams, and Jellies
13.
RBCF, Rev. bras. ciênc. farm. (Impr.) ; 44(4): 637-643, out.-dez. 2008. ilus, graf, tab
Article in Portuguese | LILACS | ID: lil-507914

ABSTRACT

A nistatina é um antibiótico poliênico, com características fungistáticas e fungicidas, que age desestruturando a membrana celular de fungos e leveduras. O creme vaginal de nistatina é usado para o tratamento da candidíase vaginal. Até recentemente, os compêndios oficiais preconizavam o ensaio microbiológico para doseamento deste antibiótico, método este considerado inviável na rotina de centros de controle de qualidade, devido ao tempo excessivo para liberação dos resultados. Visando obter um método alternativo para o doseamento do creme vaginal de nistatina, procurou-se desenvolver e validar um método cromatográfico (CLAE). O método desenvolvido utilizou como fase estacionária uma coluna de fase reversa, C18, 3,9 x 150 mm, 4 mm, à temperatura de 30 ºC. A fase móvel foi constituída por tampão fosfato de sódio 0,25 mM e EDTA 0,025 mM, pH 6,00, metanol e acetonitrila (40:30:30), vazão de 1,0 mL/minuto e comprimento de onda 305 nm. O método validado revelou-se exato, preciso, robusto, linear e específico, além de rápido e prático, podendo ser utilizado para o doseamento analítico de creme vaginal de nistatina.


Nystatin is a polyenic antibiotic with fungistatic and fungicide characteristics that acts by de-structuring the cellular membrane of fungi and yeast. The nystatin vaginal cream is used for the treatment of vaginal candidiasis. Until recently, the official compendia professed the microbiological trial for dosing this antibiotic, method considered as non-feasible in the routine of quality control centers due to the excessive time for release of results. Aiming at obtaining an alternative method for dosing nystatin vaginal cream, a chromatographic method (HPLC) was developed and validated. The method developed used a reversible phase column of C18, 3.9 x 150 mm, 4 mm, at 30 ºC. The mobile phase was made up of a 0.25 mM sodium phosphate buffer and 0.025 mM EDTA, pH 6.00, methanol and acetonitrile (40:30:30), rate of 1.0 mL/minute and wavelength of 305 nm. The validated method showed to be accurate, precise, robust, linear and specific, in addition to being fast and practical, able to be used for analytic dosing of nystatin vaginal cream.


Subject(s)
Analytic Sample Preparation Methods , Chromatography, High Pressure Liquid/methods , Nystatin/administration & dosage , Validation Studies as Topic , Vaginal Creams, Foams, and Jellies/administration & dosage
14.
Pejouhandeh: Bimonthly Research Journal. 2008; 13 (3[63]): 193-202
in Persian | IMEMR | ID: emr-89812

ABSTRACT

Bacterial vaginosis [BV] is one of most prevalent complications among fertile women. Metronidazole prescription which is considered the first choice remedy for BV is usually followed by few side-effects. Besides, there is a growing tendency toward herbal medicines for treatment of vaginitis. Antibacterial and antifugal effects of Zataria multiflora have been demonstrated through in-vitro and in-vivo. This study aimed to compare therapeutic effects of Zataria Multiflora vaginal cream and Metronidazole vaginal cream on bacterial vaginosis. This was a randomized clinical trial on 90 married women aged 18-40, affected by bacterial vaginosis who attended for treatment to gynecology clinic of "Shabih-Khani hospital". They randomly divided into two groups each consisted 45 participants. Diagnostic criteria were Amsel's criteria and gram-stain. Zataria Multiflora vaginal cream or Metronidazole vaginal gel was prescribed for a five-night period for each group. After 2 to 7 days of administration, therapeutic effects, complications and the Amsel criteria were reassessed. Data analysis was performed by McNemar test to compare both the complications, Amsel's criteria and gram-stain in each group in their before and after treatment course. Fisher exact test was applied to compare the therapeutic effects between two groups. Complication and the Amsel criteria significantly decreased after treating by Zataria Multiflora vaginal cream or Metronidazole vaginal gel [P<0.05]. Relative risk for unresponsiveness treatment with Zataria Multiflora, to Metronidazole treatment was 1.5 [CI 95%: 0.27-8.27] which was not significant and both had therefore, similar therapeutic effects on VB. Zataria Multiflora vaginal cream has similar therapeutic effects to Metronidazole vaginal gel on VB. Thus, it could be an appropriate choice for VB treatment for those interested in herbal medicines or affected by side-effects of Metronidazole


Subject(s)
Humans , Female , Vaginosis, Bacterial/drug therapy , Terpenes , Metronidazole , Administration, Intravaginal , Vaginal Creams, Foams, and Jellies , Treatment Outcome , Clinical Trials as Topic , Plants, Medicinal
15.
Article in English | IMSEAR | ID: sea-19822

ABSTRACT

BACKGROUND & OBJECTIVE: The number of HIV infected women is steadily increasing worldwide and women controlled methods to prevent HIV are urgently needed. Vaginal microbicides are products for vaginal administration that can be used to prevent HIV infection and other sexually transmitted diseases (STDs). We conducted a Phase I safety and acceptability study of Praneem polyherbal tablet, a candidate microbicide, among HIV uninfected women in Pune, India. METHODS: Twenty eligible women were requested to use the product intravaginally once daily for 14 consecutive days between menses. Safety was assessed by clinical examination, laboratory monitoring and colposcopy. Acceptability was assessed after 14 days of product use through structured questionnaires, focus group discussions among participating women, and in-depth interviews with a subset of 5 randomly selected male partners. RESULTS: Praneem polyherbal tablet was found acceptable by the study participants with 90 per cent of the participants showing 80 per cent and more acceptability score. Discharge of the product residue was reported as a concern by 6 (30%) of participants. Nineteen (95%) female participants liked the smell and the same number reported that the product was easy to use and did not affect the usual sexual pleasure. However, men reported lack of sexual satisfaction. INTERPRETATION & CONCLUSION: Product characteristics received good acceptability score in women. However, studies of long-term safety and acceptability among at-risk population would provide more detailed information about its long term acceptability.


Subject(s)
Adult , Anti-Infective Agents/administration & dosage , Female , HIV Infections/prevention & control , Humans , India , Male , Patient Compliance , Phytotherapy , Plant Extracts/administration & dosage , Quinine/administration & dosage , Sexual Partners , Vaginal Creams, Foams, and Jellies
16.
Almustansiriya Journal of Pharmaceutical Sciences. 2006; 3 (1): 75-85
in English | IMEMR | ID: emr-75762

ABSTRACT

The ability of local mucoadhesive vaginal aqueous gel to deliver the antibacterial, antiprotozoal tinidazole [TND] to vaginal endolayers is dependent on its releasing out of the drug from vehicle to the mucosal layer of the vagina and then exert its local effect. This depends upon the physicochemical properties of the drug, vehicle and the composition of the releasing medium used. The effect of different concentration of carbomer 941[0.5, 1 and 2% w/w] on the release of TND [2%w/w] from the aqueous gel base in absence and presence of various concentration of propylene glycol [PG] to the stimulant vaginal fluid [S.V.F] medium was investigated. The release of TND from low concentration of carbomer [0.5% w/w] aqueous gel base was higher and its followed fickian mechanism of the release while an anomalous mechanism holds the releasing of drug from a high concentration of carbomer [1 and 2% w/w] aqueous gel base, the release of TND from aqueous gel containing low concentration of PG was markedly higher than that of aqueous gel having a higher concentration of PG. The solubility of TND in different concentration of PG: water solution were also investigated. The releasing method were carried out using both S.V.F [pH4.2] and citrate buffer [pH4.2]. It was found that the using of S.V.F considered to be useful for the evaluation of topically prepared vaginal dosage form as a releasing medium. Furthermore the swelling index or [swelling percent] of I gm carbomer polymer in S.V.F was measured after 4 hours incubation of the dry polymer in the fluid. The initial rate of swelling and the swelling equilibrium of [0.5, 1 and 2% w/w] dry carbomer in the S.V.F were also investigated, 0.5% w/w cabomer aqueous gel has a high rate of swelling and swelling to equilibrium size rapidly, while 1 and 2% w/w carbomer aqueous gel having a low rate of swelling and swelling to equilibrium size slowly


Subject(s)
Vaginal Creams, Foams, and Jellies , Acrylic Resins , Propylene Glycol , Tinidazole/administration & dosage
17.
DARU-Journal of Faculty of Pharmacy Tehran University of Medical Sciences. 2006; 14 (4): 172-177
in English | IMEMR | ID: emr-76414

ABSTRACT

The lactobacilli which are present in vaginal fluids play an important role in prevention of vaginosis and there are considerable interests in formulation of these friendly bacteria into suitable pharmaceutical dosage forms. Formulating these microorganisms for vaginal application is a critical issue as the products should retain viability of lactobacilli during formulation and also storage. The aim of this study was to examine the viability and release of Lactobacillus acidophilus from slow-release vaginal tablets prepared by using six different retarding polymers and from two effervescent tablets prepared by using citric or adipic acid. The Carbomer-based formulations showed high initial viablility compared to those based on HPMC-LV, HPMC-HV, Polycarbophil and SCMC polymers which showed one log decrease in viable cells. All retarding polymers in slow release formulations presented a strong bacterial release at about 2 h except Carbomer polymers which showed to be poor bacterial releasers. Although effervescent formulations produced a quick bacterial release in comparison with polymer based slow-release tablets, they were less stable in cold storage. Due to the strong chelating characteristic of citric acid, the viability was quickly lost for aqueous medium of citric acid in comparison with adipic acid based effervescent tablets


Subject(s)
Microbial Viability/drug effects , Vaginal Creams, Foams, and Jellies , Chemistry, Pharmaceutical
18.
Korean Journal of Perinatology ; : 62-67, 2006.
Article in Korean | WPRIM | ID: wpr-210616

ABSTRACT

OBJECTIVE: The purpose of this study is to evaluate the effect of Vitamin-C vaginal tablets on vaginal pH and vaginitis symptoms of pregnant women. METHODS: Ninety pregnant women who visited the antenatal clinic were included in this study after giving their informed consent. The treatment regimen of the vitamin-C vaginal tablets (250 mg, Vagi-C(R), Taurus Pharma GmbH, Germany) was one tablet given once a day for 6 consecutive days. Vaginal pH was measured the day before and the day after the Vit-C vaginal treatment. Ninety women of initial, ten failed to follow-up (participate). After routine screening using microscopic analysis of the vaginal smears, 31 of the 80 participating women fell into one of 3 pathologic groups (15 monilial infection, 10 bacterial vaginosis, 6 trichomonial infection) and leaving 49 pathogen-free pregnant women. 10 of the pathogen-free pregnant women were excluded during the study because they did not complete the treatment period due to vaginal irritation such as itching or burning sensations. The diagnosis of each vaginal infection was made by specific pathologic findings. RESULT: Mean vaginal pH values for the pathology group decreased significantly from 4.9 to 4.2. Pathologic findings of each infection were also improved without specific treatment. Bacterial vaginosis disappeared in 80.0% (8/10) of patients. The specific pathogens of the remained two vaginitis types were not detected in 33.3% (5/15) of monilial infection and 33.3% (2/6) trichomonial infection 1 week after discontinuation of Vitamin-C vaginal tablets. Although it is not significant, mean vaginal pH values decreased from 4.4 to 4.2 in the pathogen-free pregnant women. CONCLUSION: Vitamin-C, when vaginally applied, is effective in lowering vaginal pH and in the treatment of vaginitis in pregnant women.


Subject(s)
Female , Humans , Pregnancy , Burns , Diagnosis , Follow-Up Studies , Hydrogen-Ion Concentration , Informed Consent , Mass Screening , Pathology , Pregnant Women , Pruritus , Sensation , Vaginal Creams, Foams, and Jellies , Vaginal Smears , Vaginitis , Vaginosis, Bacterial
19.
Iranian Journal of Obstetric, Gynecology and Infertility [The]. 2005; 8 (2): 33-42
in Persian | IMEMR | ID: emr-71272

ABSTRACT

Vaginal candidiasis is one of the most common genital infections, which has many different therapeutic methods. Some Para clinical researches suggest garlic for treatment of candidiasis.The purpose of this study was to compare the effect of garlic extract vaginal douche and clotrimazole vaginal cream in the treatment of women with vaginal candidiasis. This is a randomized, controlled, clinical trial on 100 non-pregnant women who came with the symptomatic vaginal candidiasis. Fresh garlic extract was provided by Pharmacologist, and then the patients whose mycologic culture was positive were randomly allocated into 2 groups of vaginal douche containing 1% garlic extract and vaginal cream containing 1% clotrimazole .All patients were treated daily for 7 days and assessed for clinical and mycological results 1-2 .week after the end of treatment. Data were obtained by interview and observation methods and were analyzed by SPSS software using Chi Square, Fisher exact test student, t-test and paired-samples t-test by the confidence of 95%. Successful response [according to clinical and mycologic results] were reported in 34.7% of Garlic users and 56.9% clotrimazole users. [P=0.026] There was not any significant difference between clinical results after treatment in both groups [51% against 66.7%] but there was a significant difference between mycologic results in both groups. [40.8% against 60.8%] [P=0.046] According to the results, percentage of successful response in users of vaginal garlic extract douche was less than users of vaginal clotrimazole cream but there was no significant statistical difference between these groups according to the clinical result. We suggest more studies about different methods and doses of this drug


Subject(s)
Humans , Female , Garlic , Vaginal Douching , Clotrimazole , Vaginal Creams, Foams, and Jellies
20.
Infection and Chemotherapy ; : 86-90, 2003.
Article in Korean | WPRIM | ID: wpr-722211

ABSTRACT

BACKGROUND: To the best of our knowledge, there has been no any report on the antibiotic susceptibility profile of Gardnerella vaginalis, determined in domestic area by the agar dilution method. Therefore, we studied on 49 strains of G. vaginalis by the agar dilution method. METHODS: One standard strain (ATCC 14018) and Forty-eight strains isolated from patients with increased vaginal discharge were included in this study. Columbia agar base containing 1% proteose peptone No. 3 was supplemented with horse serum (5%) and human erythrocyte lysate (5%) which was prepared by a new method, and this medium was used for the antibiotic susceptibility test. RESULTS: The MICs90 of clindamycin and ciprofloxacin were 0.3 g/mL and 0.6 g/mL, respectively. Amoxicillin, cefazolin, doxycycline, and erythromycin were hardly effective against most strains of G. vaginalis (NCCLS, U.S.A., 2001). Especially, MICs90 of both metronidazole and tinidazole were 80 g/ mL under micro-aerobic condition of 5% O2. CONCLUSION: For the treatment of Bacterial vaginosis, it is suggested that clindamycin or ciprofloxacin should be combined with vaginal tablet or gel of metronidazole rather than single administration of metrondazole or tinidazole.


Subject(s)
Humans , Agar , Amoxicillin , Cefazolin , Ciprofloxacin , Clindamycin , Doxycycline , Drug Resistance , Erythrocytes , Erythromycin , Gardnerella vaginalis , Gardnerella , Horses , Metronidazole , Peptones , Tinidazole , Vaginal Creams, Foams, and Jellies , Vaginal Discharge , Vaginosis, Bacterial
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