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PubMed2003

Changes in circulating concentrations of inhibins A and pro-alpha C during first trimester medical termination of pregnancy.

BACKGROUND: Both inhibin A and inhibin pro-alpha C are detectable in the circulation in increasing amounts during establishment of pregnancy. However, their origins and functions remain to be elucidated. We have studied levels of inhibin A and inhibin pro-alpha C in serum samples collected at various stages during medical termination of pregnancy with consecutive use of mifepristone and misoprostol. METHODS: Samples were collected from three groups of patients at different weeks of gestation (group A: 6-7 weeks, n = 6; group B: 7-8 weeks, n = 6; group C: 8-9 weeks, n = 6) at the time of administration of oral mifepristone, 48 h later just before administration of vaginal misoprostol and again soon after expulsion of the products of conception. Plasma concentrations of inhibin A and pro-alpha C were assayed using specific and sensitive enzyme-linked immunosorbent assays. Results were correlated with concentrations of hCG and progesterone. RESULTS: We observed a significant fall in plasma concentration of inhibin pro-alpha C following administration of mifepristone, which continued after administration of misoprostol. In contrast mifepristone had no effect on plasma levels of inhibin A, which fell steeply only after administration of misoprostol. CONCLUSIONS: These results suggest dissociation between major sources of inhibin A and inhibin pro-alpha C in early pregnancy. Treatment with mifepristone, a competitive antagonist of the progesterone receptor, resulted in a significant and rapid fall in concentrations of inhibin pro-alpha C, identifying a link between production of pro-alpha C and luteal steroidogenesis. In contrast, concentrations of inhibin A did not fall after mifepristone, identifying a predominantly feto-placental origin in early human pregnancy.

Abortifacient Agents, Steroidal↗
PubMed2003

A prospective, randomized, placebo-controlled trial on the use of mifepristone with sublingual or vaginal misoprostol for medical abortions of less than 9 weeks gestation.

BACKGROUND: A combination of mifepristone and misoprostol provides an effective method of medical abortion for early pregnancy. This is the first randomized trial comparing the use of sublingual misoprostol with vaginal misoprostol in combination with mifepristone for termination of early pregnancies up to 63 days. METHODS: A total of 224 women who requested legal termination of pregnancy up to 63 days were randomized by computer- generated list into two groups and given 200 mg of oral mifepristone followed 48 h later by either 800 micro g of sublingual (n = 112) or vaginal (n = 112) misoprostol. RESULTS: Complete abortion occurred in 98.2% (95% CI: 93-99) of women in the sublingual group and 93.8% (95% CI: 88-97) in the vaginal group. There were three ongoing pregnancies in the vaginal group but none in the sublingual group. The median duration of vaginal bleeding was 17 days. There was no serious complication. Fever, chills and gastrointestinal side-effects (nausea, vomiting and diarrhoea) were significantly more common in the sublingual group. CONCLUSIONS: The combination of mifepristone and misoprostol is effective for medical abortion up to 63 days. Both the sublingual and vaginal are effective routes of administration. Further randomized trials are required to find out the optimal dose of sublingual misoprostol that can give the highest complete abortion rate and lowest incidence of side-effects.

Abortifacient Agents, Nonsteroidal↗
PubMed2004

Effects of misoprostol on uterine contractility following different routes of administration.

BACKGROUND: The effect of misoprostol administered by different routes on pregnant uterine contractility was investigated. METHODS: Thirty-two women with a pregnancy between 8 and 11 weeks of gestation requesting termination of pregnancy were recruited. Misoprostol was administered either orally (0.4 mg), vaginally (0.4 mg) or sublingually (0.2 or 0.4 mg) according to consecutive allocation. Intrauterine pressure was recorded using a Grass polygraph connected to a pressure transducer 30 min before misoprostol was given and for 4 h thereafter. At the end of the recording, suction curettage was performed. RESULTS: The first effect observed was an increase in uterine tonus, which occurred after a significantly shorter time following oral (7.8 min) and sublingual (10.7-11.5 min) than after vaginal (19.4 min) treatment. The time to maximum tonus elevation was also significantly shorter (39.5, 47.1-51.7 and 62.2 min for the three groups respectively). Regular uterine contractions developed in all subjects following sublingual and vaginal administration but not after oral administration. The increase in uterine activity measured in Montevideo Units was significantly higher after 2 h and thereafter for sublingual and vaginal treatment than for oral misoprostol. CONCLUSIONS: Based on recording of uterine activity, sublingual misoprostol acts as rapidly as oral treatment, while development of contractions was similar to that seen following vaginal administration.

Abdominal Pain↗
PubMed2004

A randomized study comparing the use of sublingual to vaginal misoprostol for pre-operative cervical priming prior to surgical termination of pregnancy in the first trimester.

BACKGROUND: Misoprostol is an effective agent for pre-operative cervical priming before surgical termination of pregnancy in the first trimester. Previous studies have shown that both oral and vaginal routes are equally effective for such a purpose. This study aimed to compare a new route of sublingual administration to the vaginal route of administration for pre-operative cervical priming in first trimester surgical abortion. METHODS: Eighty women with gestational age <12 weeks were randomized by a computer-generated model to receive 400 micro g of misoprostol either sublingually or vaginally 3 h prior to vacuum aspiration. The primary outcome measure was the degree of cervical dilatation, and secondary outcomes included the force required to dilate the cervix from 3 to 8 mm, intra-operative blood loss and incidence of pre-operative side-effects. RESULTS: There was no significant difference in the baseline cervical dilatation (sublingual: 7.6 +/- 1.3 mm; vaginal: 7.7 +/- 0.73 mm), cumulative force required to dilate the cervix from 3 to 8 mm (sublingual: 9.0 +/- 9.8 N; vaginal: 6.6 +/- 5.4 N) and total blood loss (sublingual: 52.1 +/- 20.2 ml; vaginal: 48.3 +/- 12.3 ml). Pre-operative side-effects were also similar. CONCLUSIONS: Both sublingual and vaginal misoprostol are effective in cervical priming before surgical termination of pregnancy in the first trimester. Sublingual misoprostol has the advantage of being more convenient to administer and may be more suitable for day surgery.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation.

BACKGROUND: Several studies have now reported the successful use of the sublingual administration of misoprostol for medical abortion in the first trimester. The objective of this study was to assess the acceptability to women, the efficacy of the regimen, as well as the acceptability to staff of sublingual versus vaginal administration of misoprostol following mifepristone for medical abortion at 13-20 weeks gestation. METHODS: Women were randomized by opening consecutive sealed envelopes generated using random number tables. Mifepristone (200 mg) was followed 36-48 h later by sublingual administration of misoprostol 600 microg or vaginal misoprostol 800 microg. This was followed by 3 hourly doses of misoprostol 400 microg administered sublingually or vaginally. RESULTS: A total of 76 women were randomized. Of women in the sublingual group, 24 (66.7%) expressed satisfaction with the route of misoprostol administration compared with 25 (62.5%) in the vaginal group. A higher proportion in the sublingual group used intramuscular opiates. There was no significant difference in the surgical evacuation rate between the sublingual (three out of 36 women, 8.3%) and vaginal groups (one out of 40, 2.5%), (P=0.26) and acceptability to staff was the same for both methods. CONCLUSIONS: Sublingual administration of misoprostol following mifepristone is an acceptable and effective alternative to vaginal administration for medical abortion at 13-20 weeks gestation. However, women should be advised about the greater likelihood of requiring stronger analgesia.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Misoprostol for cervical ripening in non-pregnant women: a randomized double-blind controlled trial of oral versus vaginal regimens.

BACKGROUND: The objective was to compare the efficacy of oral versus vaginal misoprostol for cervical ripening in non-pregnant women. METHODS: Sixty non-pregnant women scheduled for diagnostic hysteroscopy were randomized by computerized randomization schedule to 400 microg of misoprostol orally (n = 30) or 200 microg vaginally (n = 30) administered 12 h prior to surgery. The diameter of the cervical canal measured with a Hegar dilator, adverse events and any complications were recorded and compared between the two groups. RESULTS: The mean pre- and post-medication cervical canal diameter and cervical diameter difference were 2.00 +/- 1.93 versus 2.37 +/- 1.83 mm (P = 0.453), 5.10 +/- 1.75 versus 5.60 +/- 1.69 mm (P = 0.265) and 3.10 +/- 1.79 versus 3.23 +/- 1.74 mm (P = 0.771) in the oral and vaginal group, respectively. Seven patients in the oral group and one patient in the vaginal group experienced diarrhoea within 24 h of administration of the misoprostol. CONCLUSION: Oral misoprostol 400 microg had similar efficacy in cervical ripening to 200 microg of vaginal misoprostol.

Administration, Intravaginal↗
PubMed2007

Effect of oral administration of dydrogestrone versus vaginal administration of natural micronized progesterone on the secretory transformation of endometrium and luteal endocrine profile in patients with premature ovarian failure: a proof of concept.

BACKGROUND: We aimed to explore the endometrial histology and endocrine profiles on day 21 of an artificial cycle in patients with premature ovarian failure (POF) treated with oral dydrogesterone (DG) or vaginal micronized progesterone. METHODS: The study was designed as a prospective pilot study at an academic reproductive medicine unit. Six POF patients were included in the study. After estrogen endometrial priming, patients were randomized to receive DG or progesterone in two subsequent cycles. The main outcome measure was the endometrial histology and the endocrine profiles on day 21 of the cycle. RESULTS: Development of endometrial glands corresponded to an early secretory phase in five out of six cases supplemented with DG (out-phase). In contrast, five out of six cases treated with micronized progesterone showed an endometrium corresponding to a mid-luteal phase (in-phase) (P = 0.021 versus DG). There was a significant difference in the mean progesterone value [8.6 versus 0.3 microg l(-1) (P = 0.013)], the mean LH value [12.9 versus 22.5 IU l(-1) (P = 0.049)] and the mean FSH value [13.0 versus 23.9 IU l(-1) (P = 0.047)] between the progesterone and DG group, respectively, on day 21 of the cycle. CONCLUSIONS: After estrogen endometrial priming in POF patients, exogenous vaginal micronized progesterone is more effective than oral DG in creating an 'in-phase' secretory endometrium and induces significantly higher progesterone and lower LH and FSH serum concentrations on day 21 of the cycle.

Administration, Intravaginal↗
PubMedDate not supplied

Preparation of the cervix for surgical termination of pregnancy in the first trimester.

Worldwide, surgical vacuum aspiration is the method of choice of terminating first trimester unwanted pregnancy. Cervical priming prior to surgical evacuation reduces the risks of cervical injury by making the cervix softer and easier to dilate. Over the years, a number of effective methods of cervical priming have became available: osmotic dilators; antiprogesterone and prostaglandins. Of these, prostaglandins remain the most widely used method of cervical preparation. However many of the natural and synthetic analogues of prostaglandins are either expensive or associated with troublesome side-effects. More recently, misoprostol, a synthetic 15-deoxy-16 hydroxy 16-methyl analogue of naturally occurring prostaglandin E, used in the management of peptic ulcers, has established a lead for cervical priming in terms of availability, ease of administration, cost and effectiveness. In fact it appears that both oral and vaginal misoprostol given at dosages of 400 microg are effective for cervical priming when administered 3 h prior to surgical vacuum aspiration. Now that the use of misoprostol for cervical priming has been validated, its widespread use in gynaecological practice is expected.

Abortifacient Agents, Nonsteroidal↗
PubMed1982

The biological activity of retinotaurine.

The ability of the biliary metabolite retinotaurine to reverse the cornification of vaginal epithelial cells induced by vitamin A deficiency was assessed using a vaginal smear assay. Retinotaurine activity was examined following the intravaginal administration of 10(-12) mol to 10(-8) mol of this compound per vagina. This metabolite exhibited no detectable activity at any dose tested. These results show that retinotaurine cannot be more than 1% as active as all-trans-retinoic acid since retinoic acid shows a response at concentrations of 10(-10) mol per vagina. The low biological activity of this recently identified biliary metabolite suggests that it represents an excretory form of retinoic acid.

Animals↗
PubMed1994

Postmenopausal estrogen replacement therapy and the risk of Alzheimer's disease: a population-based case-control study.

Preliminary animal and human data suggest that estrogens may be protective against Alzheimer's disease in women. In a population-based case-control study at Group Health Cooperative of Puget Sound, Seattle, Washington, the authors compared the exposure of estrogen replacement therapy of 107 female Alzheimer's disease cases with 120 age- and sex-matched controls by using computerized pharmacy data. The cases were obtained from the Alzheimer's Disease Patient Registry of the University of Washington, Seattle, Washington, which is based on the enumerated health plan population from 1987 to 1992. Newly recognized cases of probable Alzheimer's disease according to standardized diagnostic criteria were ascertained, evaluated, and enrolled in the Registry. The controls were selected from the same defined population by stratified random sampling. When the authors applied logistic regression, ever use of estrogens did not show an association with Alzheimer's disease (adjusted odds ratio = 1.1, 95 percent confidence interval 0.6-1.8). Oral and vaginal estrogens yielded similar results. In conclusion, this study provides no evidence that estrogen replacement therapy has an impact on the risk of Alzheimer's disease in women.

Administration, Intravaginal↗
PubMed1992

Controlled preparation of the endometrium with exogenous oestradiol and progesterone: a novel regimen not using a gonadotrophin-releasing hormone agonist.

In women having inactive ovaries, controlled preparation of the endometrium has been achieved with exogenous oestradiol and progesterone. We report on the feasibility and practicality of using a similar regimen for timing transfers of cryopreserved embryos in women whose ovaries have not been suppressed. A total of 91 women having cryopreserved embryos from previous in-vitro fertilization (IVF) attempts received 4 mg/day of oestradiol valerate, starting on cycle day 1 of spontaneous (n = 85) or induced (n = 6) menstruation. A single blood sample was obtained on cycle day 14 for the measurement of plasma progesterone, oestradiol and luteinizing hormone (LH). Vaginal administration of micronized progesterone (300 mg/day) was started on day 15. Cryopreserved embryos were transferred on day 17 or 18 provided that day 14 plasma progesterone remained < or = 0.5 ng/ml, thereby confirming the absence of spontaneous ovulation prior to the administration of exogenous progesterone. Out of 91 cycles studied, plasma progesterone was found to be elevated (> 1 ng/ml) in only three (3.2%). Of the 88 scheduled transfers, 31 did not take place because no embryo survived thawing. In the remaining 57 cycles, 116 embryos were transferred resulting in 10 pregnancies, giving pregnancy and embryo implantation rates of 17.5 and 8.6% respectively. When a positive beta human chorionic gonadotrophin (HCG) titre was obtained, supplementation with oral oestradiol and vaginal progesterone was continued until placental autonomy was achieved. Of the 10 pregnancies, five (50%) were lost during the first trimester (biochemical, n = 1; miscarriage, n = 3; ectopic, n = 1).(ABSTRACT TRUNCATED AT 250 WORDS)

Abortion, Spontaneous↗
PubMed1993

The abortifacient effect of misoprostol in the second trimester. A randomized comparison with gemeprost in patients pre-treated with mifepristone (RU486).

The objective of this work was to study the abortifacient effects of misoprostol, an orally active prostaglandin E1 (PGE1) analogue, in the second trimester. A randomized study of two prostaglandin regimens in women pre-treated with the antiprogesterone mifepristone was carried out in the gynaecological wards of Aberdeen Royal Hospitals, NHS Trust, and included 60 women at 13-20 weeks' gestation, in whom termination of pregnancy had been agreed. Following pre-treatment with mifepristone 600 mg women were randomly allocated to one of two prostaglandin regimens which started 36-48 h later. The first misoprostol 400 micrograms orally (up to three doses) followed by gemeprost vaginal pessary 1 mg up to two doses. The second was gemeprost vaginal pessary 1 mg up to five doses. The main outcome measures were success rate induction-to-abortion interval and side-effects. There were no significant differences between the two groups in any of the main outcome measures. We conclude that misoprostol is a stable, cheap PGE1 analogue with demonstrable efficacy and acceptable side-effects in the management of second trimester abortion. Further work is needed to establish the optimum dose and regimen.

Abortifacient Agents, Nonsteroidal↗
PubMed2004

PHI-443: a novel noncontraceptive broad-spectrum anti-human immunodeficiency virus microbicide.

PHI-443 (N'-[2-(2-thiophene)ethyl]-N'-[2-(5-bromopyridyl)] thiourea) is a rationally designed novel thiophene thiourea nonnucleoside reverse transcriptase inhibitor (NNRTI) with potent anti-HIV activity against the wild-type and drug-resistant primary clinical human immunodeficiency virus (HIV-1) isolates. This study examined the potential utility of PHI-443 as a nonspermicidal microbicide for prevention of sexual transmission of HIV. Our goal in this study was to test the effects of PHI-443 on in vivo sperm functions under conditions shown to inactivate viruses in human cells. PHI-443 completely prevented the vaginal transmission of a genotypically and phenotypically drug-resistant HIV-1 isolate in the humanized severe combined immunodeficient (Hu-SCID) mouse model of sexually transmitted AIDS. Exposure of human sperm to PHI-443 at doses 30 000 times higher than those that yield effective concentrations against the AIDS virus had no adverse effect on sperm motility, kinematics, cervical mucus penetrability, or the viability of vaginal and cervical epithelial cells. Exposure of rabbit semen to PHI-443 either ex vivo or in vivo had no adverse impact on in vivo fertilizing ability in the rabbit model. Reproductive indices (i.e., pregnancy rate, embryo implantation, and preimplantation losses) were not affected by pretreatment of rabbit semen with PHI-443. Likewise, intravaginal application of 2% PHI-443 via a self-emulsifying gel at the time of artificial insemination resulted in healthy offspring with no apparent peri- or postnatal repercussions. Repeated intravaginal administration of 0.5%- 2% PHI-443 gel was found to be safe in rabbits and lacked systemic absorption. PHI-443 has clinical potential as a prophylactic broad-spectrum anti-HIV microbicide without contraceptive activity.

Absorption↗
PubMed2002

Human sperm-specific peptide vaccine that causes long-term reversible contraception.

A novel dodecamer peptide sequence, YLP(12), was identified on human sperm that is involved in oocyte binding. We investigated its immunocontraceptive effects in a murine model. A vaccine was prepared by conjugating the synthetic YLP(12) peptide with the binding subunit of recombinant cholera toxin. Vaccination of female mice by i.m. or intranasal routes without any additional adjuvant induced a sperm-specific immune response in serum and the vaginal tract that caused a long-term contraceptive state. Fertility was fully regained when antibody reactivity diminished at 305-322 days. The contraceptive effect was also completely reversed voluntarily by intravaginal administration of the peptide. Antibodies affected fertility at the prefertilization stage by inhibiting sperm capacitation and the acrosome reaction, and sperm-oocyte binding. The peptide sequence is an epitope of a 50 +/- 5-kDa membrane protein localized on the acrosome and tail of spermatozoa. Thus, the sperm-specific YLP(12) is an attractive candidate for contraceptive vaccine.

Acrosome Reaction↗
PubMed2003

New options in contraception for teenagers.

PURPOSE OF REVIEW: Unintended pregnancy continues to exact a considerable economic, social and personal cost in industrialized nations despite the ready availability of safe, reliable and highly effective methods of contraception. Adolescents still demonstrate some of the highest rates of unintended pregnancy and thus may benefit from considering new contraceptive options that provide unique side effect profiles or delivery systems that could facilitate and improve compliance of contraceptive methods. RECENT FINDINGS: The recent launch of several new combination oral contraceptive pills with novel side effect profiles has expanded the choices for teenagers who choose to use a daily oral contraceptive. Of potentially greater interest is the recent availability of several nondaily contraceptives, as compliance remains a critical issue with successful contraceptive use in adolescents. SUMMARY: New contraceptive methods bring unique side effect profiles and delivery systems that may improve overall contraceptive compliance, especially among teenagers who are more prone to misuse from a wide array of side effect and compliance issues. Even the most accepted method, however, will not provide effective contraception if the process by which contraception is provided fails to address the unique concerns and lifestyle issues of each individual adolescent.

Absorbable Implants↗
PubMed2000

Use of misoprostol in obstetrics and gynecology.

UNLABELLED: Misoprostol is prostaglandin E1 analogous and marketed for prevention and treatment of peptic ulcer disease. However, it has been used widely in obstetrics and gynecology practice because of its effectiveness, low cost, stability in light and hot climate conditions, and ease of administration compared with its licensed counterparts--dinoprostone and gemeprost. A large number of studies have shown that misoprostol is effective in first and second trimester abortion, late pregnancy labor induction, and third stage of labor management (misoprostol has not been approved by the U.S. Food and Drug Administration for these indications). Because misoprostol is not registered for such use, it has not undergone the extensive testing for appropriate dosage and safety required for registration. Serious complications such as teratogenesis after failed abortions and uterine rupture during second trimester abortions and third trimester labor induction have been reported as the result of increasingly wide use of misoprostol in obstetric and gynecology practice. There is an urgent need to evaluate all the available data and organize a large randomized trial to determine the safety of its use in obstetric and gynecology practice. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader will be able to identify the various uses of misoprostol, to describe the potential complications of misoprostol use and its teratogenic effects, to compare the various routes of administration, and to define the appropriate dose.

Abnormalities, Drug-Induced↗
PubMedDate not supplied

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

BACKGROUND: The introduction of the triazole antifungal agent fluconazole, which can be used via an oral route and single dose, has had a significant impact on patient compliance. GOAL OF THIS STUDY: To compare the efficacy and safety of a single oral dose of 150 mg fluconazole with that of a 100-mg clotrimazole vaginal suppository twice a day in the morning and at bedtime for 3 days in the treatment of vulvovaginal candidiasis. STUDY DESIGN: A single-blind, randomized controlled trial was conducted at Ramathibodi Hospital between June 1 and September 30, 1993. RESULTS: There were 53 women in the group treated with fluconazole and 50 in the group treated with clotrimazole. There was no significant difference between the two groups regarding clinical characteristics (age and length of follow-up period). Mycological cure rates approximately 1 week after treatment were 79.2% in the fluconazole group and 80.0% in the clotrimazole group. Approximately 4 weeks after treatment, these rates were 60.4% and 66.0%, respectively. The side effects were minimal and did not warrant any treatment. The differences in the results were not statistically significant. CONCLUSION: We recommend that a single oral dose of 150 mg of fluconazole be given as an alternative method of treating vulvovaginal candidiasis, but the cost is higher than for clotrimazole.

Administration, Intravaginal↗