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At least 1,315 records · Page 73Linked to original sources
PubMed1992

Low-dose oestradiol in the treatment of urogenital oestrogen deficiency--a pharmacokinetic and pharmacodynamic study.

Twenty-four postmenopausal women with vaginal atrophy due to oestrogen deficiency were treated with 17 beta-oestradiol administered as vaginal tablets containing 10 and 25 micrograms, respectively, in a slow-release system (Vagifem, Novo Nordisk, Denmark). All the women were treated for 2 weeks with each dose in a double-blind, cross-over study. Plasma concentrations of unconjugated oestradiol and unconjugated oestrone were measured at regular intervals for 24 h on days 1 and 14 of each treatment regimen. Cytological and clinical evaluations of the vaginal and urethral epithelium were also carried out. Initially, when the epithelium was still atrophic, dose-dependent absorption of oestradiol was demonstrated. After 14 days of treatment maturation of the vaginal epithelium was seen with both regimens and the absorption of oestradiol then declined significantly on both the 10 and the 25 micrograms dose. Oestrone levels remained unchanged and gonadotrophin levels were unaffected during treatment. Vaginal cytology showed maturation on both the 10 and the 25 micrograms dose, whereas urethral cytology showed a reduction in parabasal cells that was significant only on 25 micrograms. Clinical and subjective improvement was apparent on both doses and acceptance of treatment was good.

Administration, Intravaginal↗
PubMed1993

Oestradiol-releasing vaginal ring for treatment of postmenopausal urogenital atrophy.

A silicone vaginal ring releasing 5-10 micrograms oestradiol/24 h for a minimum of 90 days has been developed for treatment of urogenital mucosal atrophy. The efficacy, safety and acceptability of the oestradiol-releasing ring were studied in 222 postmenopausal women with symptoms and signs of atrophic vaginal mucosa. The maturation of the vaginal epithelium, as measured by cytological parameters, was significantly improved during treatment. No proliferation of the endometrium was encountered. The therapy had a significant effect on symptoms (vaginal dryness, pruritus vulvae, dyspareunia, urinary urgency) and on signs of atrophic vaginitis, with cure/improvement registered in > or = 90%. The patient acceptability was high, since > or = 90% did not report any discomfort with the ring. Almost all of the sexually active women had the ring in place during coitus and in < or = 2% of cases discomfort was noticed by them or the partner. It is concluded that a vaginal silicone ring giving a continuous release of an ultra-low dose of oestradiol is an effective and safe treatment for urogenital oestrogen deficiency. No addition of progestagen is needed.

Administration, Intravaginal↗
PubMed1995

Transvaginal estriol administration in postmenopausal women: a double blind comparative study of two different doses.

A group of 72 postmenopausal women were treated for 4 weeks with vaginal suppositories containing 0.5 or 1.0 mg of estriol. The two different doses achieved an identical significant improvement of urogenital symptoms, while a dose-related effect seen to be on climacteric complaints, according to a good absorption of estriol by the vaginal epithelium. Minimal side effects were observed and the safety of vaginal estriol treatment could advise further study about the effect of this kind of treatment on the climacteric syndrome.

Administration, Intravaginal↗
PubMed1996

Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women.

OBJECTIVES: This study was designed to evaluate the efficacy of Replens, a non-hormonal moisturizing vaginal gel, on symptoms of vaginal atrophy in postmenopausal women, in comparison with Dienoestrol (Cilag), an oestrogenic vaginal cream. METHODS: Thirty-nine patients were randomly allocated to either of the two treatments. Replens was given three times a week during the 12 weeks of the study, while Dienoestrol was administered daily during the first 2 weeks and thereafter three times a week. Vaginal dryness index, itching, irritation, dyspareunia, pH and safety were evaluated every week the first month and every month thereafter. RESULTS: Both treatments had a significant increase on vaginal dryness index as soon as the first week of treatment, and the hormonal compound was significantly better than the non-hormonal one. All symptoms such as itching, irritation and dyspareunia significantly decreased or disappeared without any difference between the two treatments. For pH, no significant difference was seen either in each group or between the two groups. No adverse events related with the two drugs were found. CONCLUSION: This study shows that Replens applied vaginally three times a week, is a full therapy for all symptoms of vaginal atrophy as well as local estrogen. No serious adverse event was related. Replens is an alternative treatment to local estrogen and perhaps a good complement of systemic HRT in patient suffering from vaginal dryness.

Administration, Intravaginal↗
PubMed1995

The estradiol vaginal ring--a study of existing clinical data.

Eleven reports on clinical trials with the estradiol vaginal ring have been completed to date. In five of these, the ring was compared with other vaginally-applied estrogen preparations while in the other six trials there were no parallel controls. Three trials with no parallel controls were carried out on patients who had participated in previously controlled studies. In the controlled studies, reference therapy included an estriol pessary in two, conjugated estrogen cream in two and an estriol vaginal cream in one. After 3 and 12 weeks of treatment in the non-controlled studies, vaginal maturation by cytologic as well as physician assessment was documented. These urogenital maturation changes were associated with improvement or elimination of patient symptoms in 67%-100% of the subjects. Average plasma levels of estradiol, with first and second ring, indicated a transient Cmax of 232 and 162 pmol/l, respectively, but with steady-state concentrations at 28 and 21 pmol/l, respectively. In the five controlled studies, patients were randomized to the agents mentioned above or to the ring, and the dependent variables were vaginal and urinary symptoms reported by subjects and physician and cytopathologic evaluation of the urogenital tissue. These variables were vaginal dryness, pruritus, dyspareunia, dysuria, urinary urgency and stress incontinence. Physician assessment of overall improvement in vaginal and urinary status and cytologic maturation value and vaginal pH were also recorded. Statistical analysis of each trial revealed no significant difference between treatments, and good patient acceptance of the ring. The longer term studies (over 1 year) indicated good to excellent patient acceptance of this low dose estradiol-releasing vaginal ring in the treatment of symptoms associated with urogenital ageing. In summary, clinical experience from 946 postmenopausal women treated with the ring for up to 96 weeks indicates a good response with respect to patient complaints and physical and cytologic examination, without serious adverse reactions.

Administration, Intravaginal↗
PubMed1995

New kinetic data on estradiol in light of the vaginal ring concept.

The principal estrogen produced by the functioning premenopausal ovary is 17 beta-estradiol. At the point of irreversible ovarian failure, at menopause, the production of estradiol decreases dramatically, which results in circulating serum levels less than 120 pmol/l. It is important to recognise the pharmacokinetic and metabolic outcomes associated with dosage and route of delivery of estrogen. One of the most promising methods of administering estrogen replacement therapy (ERT) for local effects is the estradiol vaginal ring designed for a controlled continuous low release (7.5 micrograms estradiol/24 h) over a period of 90 days. The present study was undertaken to characterise the basal endogenous turnover of estradiol in postmenopausal women. Information on the disposition of estradiol after an intravenous dose formed the base of the kinetic model. The rate of extent of absorption of estradiol was assessed after ring application. Individual serum concentrations of estradiol were analysed without subtraction of the basal estradiol levels. The results indicate a rapidly eliminated compound (plasma clearance 2 l/min) with a distribution of approximately 50 l, resulting in an efficient half-life of about 20 min. The endogenous production was highly variable (< 1-44 micrograms/24 h). The steady-state estradiol levels following ring application did not increase and were well within the normal basal estradiol range seen in untreated women. In light of the present findings, the low daily dose, the low availability of estradiol across the vaginal wall and the controlled local delivery, favour the use of the estradiol vaginal ring.

Administration, Intravaginal↗
PubMed1995

Clinical trial of the estradiol vaginal ring in the U.S.

Vaginal atrophy can be reversed for most women through systemic hormones. Those women who cannot take systemic hormones can get relief of symptoms with local estrogen therapy, which ideally should be locally effective without significant systemic absorption and without endometrial stimulation. An estradiol-releasing vaginal ring was therefore tested for efficacy, safety and patient acceptability in a 15-week open-label, randomized parallel group trial with blinded evaluations of the cytological response data. Conjugated estrogen vaginal cream was used as a reference control. The primary objectives of the study were to evaluate whether the two treatments were equivalent regarding improvement in urogenital atrophy, improvement in physicians's overall evaluation of product performance on urinary and/or vaginal changes, and improvement in patient's assessment of urinary and/or vaginal symptoms. A secondary objective was to assess frequency of endometrial overstimulation during estrogen replacement therapy, to be measured by a progestogen challenge test. The ring and cream treatment produced an equivalent effect on the vaginal mucosa, and equivalence was also found in physician's and patient's assessments of both vaginal and urinary symptomatology. Both treatments were equally effective in improving the vaginal pH toward levels normally seen in fertile women (< 5.0). With regard to endometrial stimulation, significantly more patients had bleedings at progestogen challenge test after 3 months of treatment with cream than with the ring. The ring, however, was given significantly better overall product acceptability ratings by the patients. It can therefore be seen as an equally effective, but significantly more acceptable, new administration form for treatment of urogenital disorders due to estrogen deficiency, with a more favourable safety profile than vaginal cream.

Administration, Intravaginal↗
PubMed1989

Investigation of the relationship between melting-related parameters and in vitro drug release from vaginal suppositories.

The effect of temperature on drug release from meteneprost potassium vaginal suppositories was investigated using a dissolution test based on the USP I apparatus. Comparison of the dissolution results with the DSC melting behaviour revealed that drug release was extremely slow until melting of the suppository was essentially complete. The melting behaviour of the meteneprost potassium suppositories was also varied by preparing suppositories from bases with higher and broader melting ranges. The observed dissolution behaviour (at 37 degrees C) confirmed that drug release increased as the melting temperature of a particular suppository decreased. Differential scanning calorimetry, viscosity and dilatometry methods were used to characterize the suppository melting process. The effects of suppository melting range, melt temperature and composition were investigated with respect to in vitro drug release. Methodology for the HPLC determination of meteneprost in suppositories and in dissolution media are also reported.

16,16-Dimethylprostaglandin E2↗
PubMed1988

Development of a vaginal gel containing 9-deoxo-16,16-dimethyl-9-methylene PGE2 for cervical dilatation and pregnancy termination.

A stable hydrophilic gel for vaginal administration containing 9-deoxo-16,16-dimethyl-9-methylene PGE2 (9-methylene PGE2) was developed and its clinical usefulness for preoperative cervical dilatation and for termination of first and second trimester pregnancy evaluated in 521 pregnant patients admitted to the hospital for therapeutic abortion. Following vaginal administration of 3 mg of 9-methylene PGE2 gel a peak plasma level of between 3.5 and 10 ng/ml was found 3 to 6 hours following treatment. The "bioavailability" of the drug was in the order of 25-30%. 9-methylene PGE2 was found to be equally effective as 1 mg Cervagem for preoperative cervical dilatation. With a pretreatment period of 3 hours side effects were rare with both compounds. If the pretreatment period was extended to 12 hours the degree of cervical dilatation, but also the frequency of side effects increased significantly. Repeated administration of 9-methylene PGE2 was found to be effective (96% complete abortion) in terminating very early pregnancy provided the total dose was 10 mg or more. During second trimester the minimum effective dose was 4.5 mg of the compound repeated every fourth hour. The results of the present study have shown that with the new gel formulation the amount of 9-methylene PGE2 needed to terminate first and second trimester pregnancy was approximately ten times less in comparison with the previously used lipid base suppositories. The treatment was also associated with a low frequency of side effects.

16,16-Dimethylprostaglandin E2↗
PubMed1989

Preinduction cervical priming with PGE2 vaginal film in primigravidae--a randomised, double blind, placebo controlled study.

Previous reports with an 850 micrograms prostaglandin E2 film for cervical ripening before induction of labour in term pregnancy have been favourable. These studies however had no controls. The present study compares this PGE2 vaginal film with a nonmedicated similar vaginal film (placebo) for preinduction cervical ripening in primigravid women at term. A total of 69 women with modified Bishop's cervical scores 1-5 were assigned randomly to either the PGE2 group (33 women) or placebo group (36 women). Cervical score assessments were made at 12 and 24 hours after which labour was induced by amniotomy and oxytocin infusion. Although the cervical scores between placebo and PGE2 groups at 12 and 24 hours were not significantly different, the scores were marginally better with the prostaglandin film. Pregnancy outcome was satisfactory in both groups with no perinatal or maternal mortality and morbidity. The caesarean rate was 30.6% in the placebo group and 24.2% in the PGE2 group. This study emphasizes the need for a control group when studying the success of agents used for ripening the pregnant cervix at term.

Administration, Intravaginal↗
PubMed2005

The use of mucoadhesive polymers in vaginal delivery.

The vagina is an important area of the reproductive tract and serves as a potential route of drug administration. Beside locally acting drugs it is also of importance for systemic drug delivery, uterine targeting or even vaccination. Currently available dosage forms have several limitations, therefore novel concepts and dosage forms are needed. In this field mucoadhesive polymers will play a major role. After discussion of the anatomy and physiology of the vagina this review highlights the most important studies based on mucoadhesive polymer-systems like poly(acrylates), chitosan, cellulose derivatives, hyaluronic acid derivatives, pectin and traganth, starch, poly(ethylene glycol), sulfated polysaccharides, carrageenan, Na-alginate and gelatine.

Administration, Intravaginal↗
PubMed2004

New biomedical approaches for sexually transmitted infection prevention: vaccines and microbicides.

STIs are a major global health problem. Biomedical strategies are under development that will help prevent these infections. Vaccines against C. trachomatis and N. gonorrhoeae are in early stages of development. Stage-III trials are underway on prophylactic vaccines for HPV and HSV-2. Strategies focused on immunizing only high-risk individuals are unlikely to stem the tide of STIs. Approaches to widespread immunization require acceptance of such vaccines by health care providers, institutions providing funding, parents, and adolescents. Microbicides offer a female-controlled method for protection from STIs. They use many strategies to prevent infection. These products are at various stages of development. It seems that young women and teenagers would be interested in using microbicides. Correct and consistent use of microbicides will require taking women's preferences into account during product development and marketing.

Administration, Intravaginal↗
PubMed2006

Advances in hormonal contraception.

This article presents a review of advances made in hormonal contraception over the past 15 years. It looks at the different routes of administration that have been developed, at newer formulations of conventional methods, and at novel contraceptive agents that are in the process of approval. The article provides a short description of each of these contraceptive methods, information about compliance, side effects, and efficacy, and an update on that particular method.

Administration, Cutaneous↗
PubMed2004

Labor induction in women with an unfavorable Bishop score: randomized controlled trial of intrauterine Foley catheter with concurrent oxytocin infusion versus Foley catheter with extra-amniotic saline infusion with concurrent oxytocin infusion.

OBJECTIVES: This study was undertaken to determine whether the addition of extra-amniotic saline infusion improves the efficacy of the Foley catheter in women undergoing cervical ripening and induction of labor with an unfavorable cervical examination. STUDY DESIGN: One hundred consenting women with a Bishop score less than 5 with singleton gestation, intact membranes, vertex presentation, who required induction of labor were randomly assigned to 2 groups: Foley alone (Foley, n=49) or to the Foley catheter with extra-amniotic saline infusion (EASI, 30 mL of NS per hour infused through the distal port of the Foley, n=51). All women received concurrent dilute oxytocin infusion per protocol. The primary analysis was intent to treat. Nonparametric tests were used as indicated. RESULTS: At randomization, the groups were well balanced for potential confounders including: parity, gestational age, prior cesarean delivery, preeclampsia, mean dilation, effacement, and Bishop score. There were no differences between the groups for time to delivery (Foley 17.7 +/- 10.5 hours vs EASI 17.4 +/- 11.7 hours, P=.9), the proportion of women delivered before 24 hours (Foley 41/49 [84%] vs EASI 39/51 [77%], P=.37) or cesarean rates (Foley 9/49 [17.7%] vs EASI 9/51 [18.4%], P=.92). There were also no differences in complications, including chorioamnionitis, endometritis, and neonatal morbidity. CONCLUSION: EASI does not increase the efficacy of cervical ripening and induction of labor with a Foley catheter and concurrent oxytocin infusion.

Administration, Intravaginal↗