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PubMed2003

Menopause: new therapies.

The risk-benefit ratio of traditional postmenopausal hormone therapy is considered by many to be unacceptable. Low-dose oestrogen-progestin therapy (oral or non-oral and continuous or pulsatile) may have a better risk-benefit ratio, but this remains unproven. Steroids with selective tissue activation, such as tibolone, alleviate symptoms and protect against bone loss, but long-term safety data are lacking. Selective oestrogen receptor modulators (SERMs), such as raloxifene, prevent bone loss when used alone, and may soon be combined with oestradiol to treat symptoms and prevent osteoporotic fracture. Effects of SERMs on the cardiovascular system are currently being evaluated.

Administration, Cutaneous↗
PubMed1999

Oral metronidazole vs. Metrogel Vaginal for treating bacterial vaginosis. Cost-effectiveness evaluation.

OBJECTIVE: To compare the cost-effectiveness of metronidazole versus Metrogel Vaginal in the treatment of bacterial vaginosis. STUDY DESIGN: Sixty consecutive patients with a clinical diagnosis of bacterial vaginosis were randomly assigned prospectively into either the metronidazole, 500 mg (twice daily for seven days by mouth) or Metrogel Vaginal (one applicator twice daily for five days) treatment group. The study patients were aged 18-30 years, without other medical problems. The patients proceeded with outpatient therapy and returned 7-10 days after the completion of treatment for reevaluation. During the study, patients refrained from sexual relations, avoided alcohol and drugs, and avoided all medication. The physician evaluated the patients for bacterial vaginosis through standard wet preparation, whiff test and pH testing prior to and after treatment. The patients were randomized by a nurse and were blinded for study purposes to the evaluating physician. RESULTS: Successful treatment outcomes for bacterial vaginosis occurred in 27 and 28 patients for Metrogel Vaginal and metronidazole, respectively, out of the original 30 patients in each study group. All patients introduced into the study completed the study without difficulty. No significant complications were found in either treatment group. Three patients treated with metronidazole experienced nausea during the treatment interval. The entire cost of treatment was $19.71 and $1.51 for Metrogel Vaginal and metronidazole, respectively. CONCLUSION: The most cost-effective treatment for bacterial vaginosis was generic metronidazole. While the use of the more expensive Metrogel Vaginal may be reasonable for patients experiencing side effects of oral metronidazole, most patients should be treated with the less expensive generic metronidazole.

Administration, Intravaginal↗
PubMed1999

One-day therapy for vaginal candidiasis. A review.

Shorter courses of therapy have been developed for most antifungal agents used for the treatment of vaginal candidiasis, including clotrimazole, econazole, isoconazole, miconazole, terconazole and fluconazole. A search of the medical literature identified 14 studies that compared single-dose therapy for vaginal candidiasis in nonpregnant women. These studies, conducted according to similar study designs, provided sufficient information to evaluate clinical and mycologic cure rates. There were few significant differences in either the clinical or mycologic cure rates of single-dose therapy, and no one therapy was consistently better than any other. Until further information is available, the choice of therapy will continue to be based on individual clinician preference.

Administration, Intravaginal↗
PubMed1999

[The first 100 early medical abortions].

Early medical abortion was introduced in Denmark in 1998. This article describes our experiences with the first 100 patients at Herlev University Hospital. The regimen was 600 mg mifepriston (RU486) given orally on day one. All women had an ultrasound examination before RU486 was given in order to ensure an intrauterine pregnancy and a gestationel age of eight weeks or less, and all had a quantitative P-hCG. On day three the patients received 1 mg gemeprost as vagitory as well as a paracetamol/-codein suppository. They were observed in the department for four hours, and were thereafter discharged no matter whether a complete abortion had occurred ot not. On day 14 a new P-hCG was taken. All women in whom the hCG value was not reduced to one half of the initial value or less underwent a new ultrasound examination. All women were given a questionnaire. The effectivity was 96%. Four of 100 women were evacuated: one due to severe vaginal bleeding four hours after application of gemeprost, two because of womiting soon after having taken RU486 and one due to incomplete abortion. Half of the women began to bleed before application of gemeprost, and 91% had bleeding for more than six days. One half had no side effects to mifepristone, the other half had mild nausea. Nine of ten patients were sufficiently relieved of pain without opioids, whereas 10% were insufficiently pain relieved. Eight of ten patients would choose the same method again, in case of a future need for an induced abortion. The reason for not preferring a medical abortion among the remaining 20% was primarily pain. Early medical abortion should be offered to all women referred for induced abortion with a gestational age of eight weeks or less.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Long-term vaginal antibody delivery: delivery systems and biodistribution.

Topical delivery systems can provide prolonged delivery of antibodies to the vaginal mucosal surface for long-term protection against infectious diseases. We examined the biodistribution of antibodies during 30 days of vaginal antibody delivery in mice. Different antibody preparations (including monoclonal IgG and IgM, as well as several different (125)I-labeled IgGs) were administered by polymer vaginal rings, which were designed to provide continuous antibody delivery. Antibody concentrations remained high in the vaginal secretions for up to 30 days after disk insertion; radiolabeled antibody was also found, at approximately 100 times lower concentration, in the blood and other tissues. The measured concentrations agreed reasonably well with a simple pharmacokinetic model, which was used to calculate mucosal and systemic concentrations as a function of antibody delivery and elimination rates. Results from the model were consistent with previously reported antibody pharmacokinetic measurements: the half-life for antibody elimination for the vagina was approximately 3 h; the half-life for IgG(1) clearance from the blood was >1 day; and the overall permeability constant for vaginal uptake of IgG was approximately 0.01 to 0.03 h(-1). These results provide important information for the design of controlled antibody delivery devices for vaginal use, and suggest that high-dose, long-term vaginal administration of antibodies may be a reasonable approach for achieving sustained mucosal and systemic antibody levels.

Administration, Intravaginal↗
PubMed1999

Current hormone replacement therapy: what are the shortcomings? Advances in delivery.

The introduction of transdermal and other parenteral delivery systems has broadened the range of options for hormone replacement therapy (HRT). Oral oestrogen is the most common initial therapy; however, direct absorption of oestradiol via the skin results in an oestradiol-oestrone ratio similar to that found in the pre-menopausal state. Both oral and transdermal oestrogen therapy have been shown to be equally effective in relieving climacteric symptoms, and in preventing osteoporosis or modifying some cardiovascular disease risk factors, although transdermal therapy tends to have fewer unwanted effects than oral. Satisfactory circulating oestradiol levels are achieved with skin patches, transdermal gel, or crystalloid oestradiol implants, and adding progestogen to protect the endometrium is well established. Sequential therapy with HRT usually produces a regular bleed, which is a major cause of patient dissatisfaction. The ideal HRT regimen is probably unobtainable, but the development of SERMs and other regimens that avoid bleeding will encourage long-term use.

Administration, Cutaneous↗
PubMed1999

[Modern noninvasive methods for terminating pregnancy in the 2nd trimester].

Pregnancy interruption upon medical indications between the 13th and 21st gestational weeks is carried out mainly by two-phase invasive techniques including intraamnial application of NaCl and vaginally prostaglandins, laminarie or solutio rivanoli, followed by a surgical treatment (instrumental revision). Because of its invasive character these techniques can cause severe complications. The application of prostaglandin analogues (P.G.) is safer but it is connected with gastrointestinal side effects and their action is often protrachirated especially "primigravida" with a undeveloped infantile P.V.C.U. the author proposes a highly effective non-invasive technique implementing the following combination: sensibilization with an antiprogestin (synthetic norsteroid--Ru 486), applied perorally: 1 tablet 200 mg; 24 hours before the intracervical (vaginal) insertion of the PGO2 tablet or gel. Results are extremely effective and good: the time for pregnancy interruption is reduced to more than 50% (average 5 to 10 hours), side effects and complications are minimized and the hospital stay is significantly reduced.

Abortifacient Agents, Steroidal↗
PubMed2000

A comparison of the Abortion Rights Mobilization and Population Council trials.

We compared the published results of the 1994-1995 Population Council (PC) trial to those from the 1996-1997 Abortion Rights Mobilization (ARM) trial to determine whether 200 mg mifepristone with 800 micrograms vaginal misoprostol is more effective and has fewer side effects than 600 mg mifepristone with 400 micrograms oral misoprostol. The complete medical abortion rate was lower in the PC trial than the ARM trial: 92% compared with 97% up to 49 days LMP (p < 0.05) and 83% versus 96% from 50 to 56 days LMP (p < 0.05). Nausea and vomiting were reported more frequently in the PC trial. The overall acceptability of the procedure was lower in the PC trial (88%) than in the ARM trial (94%), (p < 0.05). Mifepristone can be reduced from 600 to 200 mg when followed by vaginal misoprostol without loss of efficacy. Vaginal misoprostol extends the efficacy to 56 days LMP and is associated with less nausea and vomiting. Home use of misoprostol is safe and acceptable to women and decreases the number of required visits from three to two in most cases.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Termination of early pregnancy with a reduced oral dose of mifepristone and vaginal misoprostol.

OBJECTIVE: To determine the efficacy of termination of pregnancy with a reduced oral dose of mifepristone and vaginal misoprostol. DESIGN: A retrospective review of 369 medical terminations of pregnancy. SETTING: Northern General Hospital, Sheffield, UK. SUBJECTS: All women presenting for medical termination of pregnancy before 63 days' gestation between October 1996 and December 1997. INTERVENTIONS: Patients were pre-treated with mifepristone 200 mg orally, 36-48 hours before the prostaglandin E analogue, misoprostol, was administered vaginally. Two doses of misoprostol 400 micrograms, were given 2 hours apart. Women were allowed home 6 hours after the first dose of misoprostol. If the products of conception were not passed before going home, patients were to contact the hospital if bleeding did not take place within 4 days. OUTCOME MEASURES: Need for a surgical procedure and number of ongoing pregnancies after full treatment were considered primary outcome measures. RESULTS: A total of 369 women were treated with this regimen: 343 women (93.46%) aborted completely within a 6-hour observation period and did not require further intervention. A further 8 women aborted completely within the next 4 days. Overall, the complete abortion rate was 95.64%. Surgical intervention was necessary in 1.09% of the patients. No woman had serious complications. CONCLUSION: This combination is effective, safe and cost-effective in a clinical setting.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Misoprostol embryotoxicity: clinical evaluation of fifteen patients with arthrogryposis.

We report on clinical evaluations of Brazilian patients with misoprostol-induced arthrogryposis. All 15 patients had growth retardation, underdeveloped bones, short feet with equinovarus, rigidity of several joints with skin dimples and webs, decreased movement of legs stemming from neurologic impairment, bilateral symmetrical hypoplasia or atrophy of limb muscles, and absent tendon reflexes. Of the 15 patients, five had upper limb deformities in addition to lower limb involvement, and one had spinal cord disruption leading secondarily to segmental sensory loss and neurogenic bladder and bowel. Electroneuromyography of five patients indicated that the abnormalities were of neurogenic origin and suggestive of anterior horn cell defects. All of their mothers took 400-4,800 mcg of misoprostol orally or vaginally at 8 to 12 weeks of pregnancy. Our observations support a previously stated caution with regard to the embryotoxicity of misoprostol.

Abnormalities, Drug-Induced↗
PubMed2001

Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost. A randomized controlled trial.

OBJECTIVE: To compare the abortifacient efficacy and side-effects of 200 mg and 600 mg of mifepristone, followed by gemeprost 1 mg vaginally, at 57 to 63 days' gestation. DESIGN: Double-blind, randomized controlled trial. SETTING: Ten international centers. SUBJECTS: Eight hundred and ninety-six healthy women requesting medical abortion. INTERVENTIONS: Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study. MAIN OUTCOME MEASURES: Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort. RESULTS: The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group. CONCLUSIONS: The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed2001

Breast epithelial proliferation in postmenopausal women evaluated through fine-needle-aspiration cytology.

OBJECTIVE: The aim was to evaluate fine-needle-aspiration (FNA) cytology as a method of following breast epithelial proliferation in postmenopausal women during hormone replacement therapy (HRT). METHODS: Twelve healthy postmenopausal women were recruited and randomized to two different types of sequential HRT during 4 months of treatment. The women were administered continuous estradiol 50 micrograms/24 h with the addition of progestogen sequentially in the form of either vaginal progesterone gel 8 mg every 2nd day or medroxyprogesterone acetate 5 mg/day orally during 12 days per month for the complete treatment period. Fine-needle-aspiration biopsies were performed twice during the estrogen phases and twice during the estrogen plus progestogen phases of treatment. Breast epithelial proliferation was analyzed in these samples by immunocytochemistry to measure the content of the nuclear antigen Ki-67/MIB-1, which is expressed in proliferating cells. RESULTS: From the 12 women, a total number of 47 FNA biopsies were taken. Thirty-eight of these aspirates, 19 from each of the estrogen and the estrogen plus progestogen phases, were evaluable for MIB-1 content (81%). There was a non-significant increase in levels of proliferation during the combined estrogen-progestogen phase (2.1%) compared with the estrogen-only phase (1.4%). These values were similar to those previously observed during the menstrual cycle in young fertile women. CONCLUSIONS: We conclude that the FNA biopsy technique is feasible for studying proliferation not only in young, normally cycling women but also in the postmenopausal breast.

Administration, Intravaginal↗
PubMed2001

Lowering the doses of mifepristone and gameprost for early abortion: a randomised controlled trial. World Health Organization Task Force on Post-ovulatory Methods for Fertility Regulation.

OBJECTIVE: To test the efficacy of lower doses of mifepristone and gemeprost for medical induction of early abortion. DESIGN: Randomised controlled trial. Participants were blinded as to the therapy and physicians to the dose of mifepristone. SETTING: Thirteen hospital gynaecological units in different continents. PARTICIPANTS: 1,224 healthy pregnant women requesting medical abortion at <57 days from last menses. INTERVENTION: Random allocation to one of four regimens: mifepristone 50 mg by mouth followed by either 0.5 mg or 1.0 mg gemeprost vaginally on day 3; mifepristone 200 mg by mouth followed by either 0.5 mg or 1.0 mg gemeprost vaginally. We concealed the allocation sequence from clinicians enrolling participants, and maintained double blinding throughout. MAIN OUTCOME MEASURES: Incidence of complete abortion; subordinate outcome measures included side effects such as vomiting and fall in haemoglobin, as well as the need for emergency curettage and blood transfusion. RESULTS: The success rate was significantly related to the dose of mifepristone. The relative risk of failure to have a complete abortion with the lower dose of mifepristone was 1.6 (95% CI: 1.1-2.3) times that with the higher dose. The relative risk of failure with the lower dose of gemeprost (1.3; 95% CI: 0.9-1.8) did not reach statistical significance. CONCLUSIONS: A single dose of mifepristone 50 mg followed by gemeprost is inadequate for early medical abortion. There was no significant difference in side effects between the four treatment groups.

Abortifacient Agents, Nonsteroidal↗
PubMed2001

Spermicidal & contraceptive properties of Praneem polyherbal pessary.

BACKGROUND & OBJECTIVES: Though a number of barrier methods and potent spermicides are available, most of these have nonoxynol-9 (N-9) as the active ingredient which is observed to cause inflammation and genital ulceration on repeated use. The present study was undertaken to develop a safe spermicide with conjoint microbicidal properties. METHODS: A polyherbal pessary was formulated with purified ingredients from neem (Azadirachta indica) leaves, Sapindus mukerossi (pericarp of fruit) and Mentha citrata oil. Spermicidal action on human sperm was tested by Sander-Cramer slide test in vitro and by post coital tests in vivo. Contraceptive action was tested in rabbits. RESULTS: The combination of the three herbal ingredients resulted in the potentiation of the spermicidal action by 8-folds. The post coital tests confirmed the spermicidal properties of the Praneem polyherbal pessary (PPP) in women with high cervical mucous score around mid estrus. It also prevented in most women the migration of sperm into the cervical mucous. In 15 rabbits studied pregnancy was prevented by the intravaginal administration of PPP, whereas 13 of the 15 animals in the control group became pregnant. INTERPRETATION & CONCLUSION: The Praneem polyherbal pessary has potent spermicidal action on human sperm in vitro and in vivo. When applied in the vagina before mating, it prevented rabbits from becoming pregnant.

Female↗