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PubMed2001

Mifepristone and misoprostol for early abortion when no gestational sac is present.

The study was conducted to determine whether the administration of mifepristone followed by vaginal misoprostol can induce an abortion in early pregnancy when no gestational sac is present on sonogram. This report presents a prospective, pilot study of 30 healthy adult women, pregnant and seeking an abortion, and with no gestational sac on sonogram. All women had a baseline serum chorionic gonadotropin (hCG) level measured prior to using mifepristone 200 mg orally followed by misoprostol 800 mcg vaginally 48 h later, and then returned up to 4 days later for a repeat sonogram and serum hCG level. Women with initial hCG levels > 2000 IU/L were evaluated for ectopic pregnancy. At the first follow-up visit, if the hCG decreased by >50%, the women were followed with home pregnancy (25 IU/L) tests weekly until negative. If the levels did not decrease by 50%, a second dose of misoprostol was given. Surgical intervention was indicated for persistent hCG levels or excessive bleeding. Of the 30 women enrolled, the mean number of days of amenorrhea was 40 (SD 9) days. Two women had surgical intervention for continuing pregnancy, 2 had ectopic pregnancies, and 1 was lost to follow-up. Complete medical abortions occurred in 25/30 (88%) women, but when recalculated, in 25/27 (93%) women who completed the protocol and who did not have an ectopic pregnancy. There was 1 adverse event in a woman with an ongoing pregnancy who then received methotrexate. She was hospitalized a day later with a complicated pelvic infection and likely methotrexate-induced pneumonitis. Twenty-three women had a decrease in hCG at first follow-up visit of >50%. All 27 women who completed the protocol found the overall regimen acceptable. Mifepristone followed at 48 h by vaginal misoprostol were effective and acceptable in inducing an abortion in very early pregnancy. There may be a higher incidence of failure in very early pregnancies. Documentation of a complete abortion by hCG level is necessary to ensure the pregnancy is neither ongoing nor ectopic.

Abortifacient Agents, Nonsteroidal↗
PubMed2001

Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion.

Mifepristone was recently approved in the United States. Regimens with shorter intervals may be more acceptable. The objective of this study was to determine whether the oral route of misoprostol was as effective as the vaginal route of misoprostol 1 day after mifepristone. A prospective, open-labeled, randomized trial of healthy adult women up to 63 days pregnant and wanting a medical abortion were randomized to use either two doses of oral misoprostol 400 microg taken 2 h apart or misoprostol 800 microg vaginally. Women self-administered misoprostol 1 day after taking one-third of the standard dose of mifepristone (200 mg) orally. Women then returned to the clinic up to 5 days later for a repeat sonogram evaluation. A dose of vaginal misoprostol was administered to women with a continuing pregnancy who then returned 1 day later to Day 15. The primary outcome measures were a complete medical abortion by the first or by the second follow-up visits. Surgical intervention was indicated for continuing pregnancy at the second follow-up visit, excessive bleeding, or persistent products of conception 5 weeks later. One thousand one hundred sixty-eight women were enrolled. Of the 1144 (98%) women who complied with their random assignment, two oral doses of misoprostol (800 microg total) were 90% effective at inducing an abortion by the first follow-up visit, compared with one dose of misoprostol by vagina of 97% (chi(2) = 23.95, p = 0.001). By the second follow-up visit, the complete abortion rate was 95% for oral misoprostol and 99% for vaginal misoprostol (chi(2) = 21.76, p = 0.001). There were minimal differences in side effects. Women preferred the oral route. The trial demonstrated that although two doses of oral misoprostol were effective, the vaginal misoprostol was more effective at inducing an early medical abortion at 1 day after low-dose mifepristone, and the regimen could be extended to 63 days gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed2002

Randomized trial of oral versus vaginal misoprostol 2 days after mifepristone 200 mg for abortion up to 63 days of pregnancy.

This prospective, open-label, randomized trial of healthy adult women up to 9 weeks pregnant compared mifepristone 200 mg followed 2 days later with misoprostol 400 microg orally versus misoprostol 800 microg vaginally. The study was interrupted after the oral misoprostol group experienced a higher than expected failure rate. This treatment was discontinued and another substituted consisting of oral misoprostol 800 microg divided into two doses two hours apart. Women returned for a follow-up visit from Day 4 to 8. All women with a continuing pregnancy received a repeat dose of misoprostol vaginally and returned before Day 15. The primary outcome measure was a complete medical abortion without surgical intervention at the first visit. Of the 1045 women enrolled, 1011 had complete data: Group 1 (220) used oral misoprostol 400 microg, Group 2 (269) used oral misoprostol 800 microg, and Group 3 (522) used vaginal misoprostol 800 microg. At first follow-up visit, the primary outcome, that is, a complete abortion, was 84% for Group 1, 92% for Group 2, and 96% for Group 3, p < 0.001. After a second dose of vaginal misoprostol in women with on-going pregnancies at their first follow-up visit, the complete abortion rates were 91%, 95%, and 98%, respectively, p < 0.001. There were minimal differences in side effects, onset of bleeding and overall acceptability in the three groups. Mifepristone 200 mg followed by vaginal misoprostol 2 days later was more effective at inducing an abortion up to 9 weeks of pregnancy than the same dose of mifepristone followed by oral misoprostol.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Oral and vaginal misoprostol 800 microg every 8 h for early abortion.

The objective of the study was to evaluate the efficacy and safety of 800 microg misoprostol (Cytotec) every 8 h for 24 h for pharmacological abortion; the treatment was repeated if abortion did not occur in the first 24-h interval. The first misoprostol doses were always self-administered into the vagina; the second and third doses could be administered orally or vaginally depending on the amount of bleeding. Four-hundred and fifty-two women with gestations between 36 and 63 days were recruited into the study. The main outcomes assessed were: successful abortion (complete abortion without surgery), side effects, mean drop in hemoglobin, vaginal bleeding and mean time of return of menstruation. Complete abortion occurred in 409/452 (90.5%; 95% confidence interval [CI] 87%, 93%) patients. Medication to relieve symptoms was administered to all women before the first misoprostol dose. Vaginal bleeding lasted 15.9 +/- 4.4 days. The mean drop in hemoglobin, measured 14 days after abortion, was statistically significant (p = 0.0001) but without clinical relevance. According to the results obtained, 800 microg of misoprostol administered every 8 h for 24 h could be a valid method for abortion for up to 9 weeks of gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed1986

A multi-compartment vaginal ring system for independently adjustable release of contraceptive steroids.

A multi-compartment contraceptive vaginal ring system has been designed for the simultaneous zero-order release of contraceptive steroids, the rates of which can be programmed independently. This vaginal ring system consists of two or more drug-containing Silastic tubes with an outer diameter of 5 mm. The tubes with different lengths, with a total length of 16.5 cm are connected with specially-shaped glass stoppers to obtain a ring with an outer diameter of 60 mm. The stopper prevents migration of the steroids from one compartment to the other and guarantees optimal release characteristics of both steroids even after long-term storage. An additional advantage of glass is the good adherence to Silastic, enabling construction of systems with sufficient tensile strength. The release characteristics have been followed in vitro and can be programmed independently by changing the wall thickness of the tube (membrane thickness) and/or the length of each individual steroid-containing compartment. Multicompartment vaginal rings were made and tested with 3-keto-desogestrel and ethinylestradiol. The rings had an outer diameter of 60 mm, and were fabricated with independent in vitro release rates ranging from 75 to 300 micrograms/day and 10 to 30 micrograms/day for, respectively, 3-keto-desogestrel and ethinylestradiol. Using the multi-compartment vaginal ring system, contraceptive devices can be fabricated relatively simply with pre-programmed release rates for a progestogen and an estrogen to investigate the optimal daily doses for vaginal hormonal contraception.

Administration, Intravaginal↗
PubMed1997

The efficacy and tolerance of mifepristone and prostaglandin in termination of pregnancy of less than 63 days gestation; UK Multicentre Study--final results.

This paper summarizes the final results of an open multicenter study in 13 hospital gynecological units in Scotland and England. In the study, 1018 pregnant women with up to 9 week amenorrhoea received 600 mg oral mifepristone followed 48 h later by vaginal gemeprost 1 mg for the induction of first trimester abortion. Outcome was measured by assessment of the frequency of complete abortion or the need for subsequent surgical evacuation. Tolerance was assessed in terms of pain, requirement for analgesia, bleeding, and other adverse effects. There was complete abortion in 94.8% (95%CI 93.4-96.2); surgical evacuation was performed in 5.2% of patients. There was no relationship between outcome and age of gestation on the day mifepristone was given. Seven women were given a transfusion. Narcotic analgesia was administered after gemeprost to 38.1% of nullipara and 10.7% of multipara. Mifepristone and prostaglandin is an effective and acceptable alternative to surgical termination of pregnancy in the early first trimester.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Abortion induced with methotrexate and misoprostol: a comparison of various protocols.

Seven hundred fifty-six women had abortions induced with methotrexate and misoprostol. Various protocols were compared. In Group 1, phase 1, after receiving 50 mg/m2 methotrexate IM, 289 women were randomized to receive either 750 or 500 micrograms of vaginal misoprostol. In Group 1, phase 2, 84 women who had failed to abort after one dose of misoprostol were randomized to receive either vaginal or oral routes for the second dose of misoprostol given on Day 8. In Group 2, a cohort of 226 women who received 60 mg/m2 methotrexate were compared to the 289 women who received 50 mg/m2 in Group 1. There were no differences in rates of effectiveness in the various trial groups. Side effects were greater with 60 mg/m2 of methotrexate. In Group 3, a cohort of 241 women received the misoprostol in three vaginal doses 8 hr apart starting on Day 5, and were compared to the 289 women in Group 1 receiving one vaginal dose. In women whose medical abortion failed, fetuses were found to have limb abnormalities In the total group of 756 women, 88.8% aborted successfully without surgical aspiration, with only minor side effects, and the acceptance rate was high. This study indicates that medical abortions induced with methotrexate and misoprostol are safe and effective, but more research is needed to find a more effective protocol.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Oral mifepristone 600 mg and vaginal gemeprost for mid-trimester induction of abortion. An open multicenter study. UK Multicenter Study Group.

This open multicenter study was performed in 20 hospital gynecological units in the UK. The effects of 600 mg oral mifepristone as pretreatment to vaginal prostaglandin induction of second trimester abortion was studied in 267 women. The primary efficacy variable was the abortion induction interval, defined as the time taken to expel the fetus from the time of administration of the first prostaglandin pessary. Induction was commenced 36 to 48 hours following mifepristone intake. The mean abortion induction interval was 7 h. A total of 81.9% of women aborted within 12 h. There was a significant relationship between abortion induction interval and age of gestation, and a significant inverse relationship between abortion induction interval and parity. Vomiting, pelvic pain, and nausea were the most frequently reported adverse events. Two patients required transfusion and one patient with a uterine scar from a previous cesarean section suffered a ruptured uterus and hysterotomy.

Abortifacient Agents, Nonsteroidal↗
PubMed1998

Oral methotrexate and vaginal misoprostol for early abortion.

A prospective trial including 300 pregnant women seeking elective abortion was conducted to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at < or = 63 days' gestation. Subjects received methotrexate 50 mg orally and were randomly allocated to receive 800 micrograms of misoprostol vaginally 3, 4, or 5 days after administration of the methotrexate. The misoprostol dose was repeated 48 and 96 h later if abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure) and side effects. Complete abortion occurred in 273 of 300 patients (91%, 95%, CI 87, 94%) patients. No significant statistical differences were found in the success rates when misoprostol was given days 3, 4, or 5 after the administration of methotrexate (p = 0.69). Vaginal bleeding lasted 7.1 +/- 3.8 days, spotting 4.1 +/- 2.5 days, and total bleeding 11.2 +/- 4.1 days. Side effects for methotrexate were minimal, whereas, for misoprostol they were mild and transient except for pain. The use of methotrexate and misoprostol together could be an alternative to the intramuscular use of methotrexate or the use of antiprogestins and prostaglandin for medical abortion.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

Low-dose mifepristone 200 mg and vaginal misoprostol for abortion.

The objectives of this study were to determine the effectiveness, side effects, and acceptability of one-third the standard 600 mg dose of mifepristone (200 mg) to induce abortion. A prospective trial at seven sites enrolled women > or = 18 years, up to 8 weeks pregnant, and wanting an abortion. The women received 200 mg mifepristone orally, self-administered 800 micrograms misoprostol vaginally at home 48 h later, and returned 1-4 days later for ultrasound evaluation. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, persistent products of conception 5 weeks later, or other serious medical conditions. Of the 933 subjects, 906 (97%) had complete medical abortions, 22 had surgical intervention, two were protocol failures, and three were lost to follow up. Of the 746 subjects who had no or minimal bleeding before misoprostol, 80% bled within 4 h and 98% within 24 h of using misoprostol. By day 7, 95% of women had a complete abortion. Side effects were aceptable in 85% of subjects, and 94% found the procedure acceptable. Low-dose mifepristone followed by vaginal misoprostol was highly effective as an abortifacient.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Long-term follow-up after quinacrine sterilization in Vietnam. Part I: interim efficacy analysis.

OBJECTIVE: To determine the long-term efficacy of nonsurgical sterilization with quinacrine. DESIGN: Observational cohort study. SETTING: Rural provinces in northern Vietnam. PATIENT(S): Two thousand seven hundred and nine women who had quinacrine insertions between 1989 and 1993. INTERVENTION(S): Interviews in 1994, 1995, and 1996 and review of available medical records. Pregnancy rates were corrected for problems in detecting and confirming pregnancies. MAIN OUTCOME MEASURE(S): Pregnancy rates. RESULT(S): Over 90% of women were interviewed at least once. Uncorrected cumulative pregnancy rates were 12.9% at 5 y after two insertions and 27.3% after one insertion. Effectiveness varied by age group: the partially corrected pregnancy rates after two insertions were 6.8% in women 35 or older at the time of insertion and 13.0% in women under 35. A subgroup of women who received oral papaverine at the time of quinacrine insertion had lower pregnancy rates, with a cumulative uncorrected rate of 5.3% at 4 years among women of all ages. CONCLUSION(S): Efficacy of quinacrine appears reasonable for two insertions of quinacrine in women 35 and older. It may be possible to improve efficacy by the use of papaverine or the Hieu insertion technique.

Administration, Intravaginal↗
PubMed2001

Endocrine and clinical effects of micronized estradiol administered vaginally or orally.

OBJECTIVE: To determine the impact of the vaginal route of micronized estradiol (E(2)) administration upon hepatic globulin and lipid production and upon the outcome of oocyte donation cycles in which the recipients received E(2) via this route. DESIGN: Series report. SETTING: University-based assisted reproduction techniques (ART) program. PATIENT(S): Recipients of donor oocytes. INTERVENTION(S): Administration of micronized E(2) via the oral or vaginal route, oocyte donation, and embryo transfer. MAIN OUTCOME MEASURE(S): Measurements of the serum levels of free E(2), sex hormone-binding globulin (SHBG), total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very-low-density lipoprotein (VLDL), as well as endometrial thickness and pregnancy outcome. RESULT(S): Serum SHBG and lipoprotein levels were unaltered by the vaginal as compared with the oral route of E(2) administration. Serum free E(2) levels were significantly higher after vaginal administration. Ten patients who had previously failed to achieve adequate endometrial thickness with an oral regimen were found to have adequate endometrial thickness after vaginal E(2) administration and seven of them achieved an ongoing pregnancy after embryo transfer. CONCLUSION(S): Vaginal administration of micronized E(2) results in significantly higher free serum E(2) levels when compared to levels achieved after oral E(2) administration. Hepatic globulin and lipoprotein production is similar despite 10-fold higher serum E(2) levels after the vaginal administration. The greater efficiency of E(2) delivery to the endometrium after vaginal administration makes this route a good option for patients who fail to achieve adequate endometrial thickness with oral E(2) administration.

Administration, Intravaginal↗
PubMed2001

Vaginal versus oral E(2) administration: effects on endometrial thickness, uterine perfusion, and contractility.

OBJECTIVE: To compare the effects of vaginal or oral E(2) administration on endometrial thickness, uterine perfusion, and contractility. DESIGN: Prospective, randomized, crossover study. SETTING: Assisted Reproduction Unit, Clamart, France. PATIENT(S): Thirty-nine infertile women undergoing 78 E(2)/P cycles. INTERVENTION(S): Women received micronized 17beta-E(2), 2 mg/day orally (cycle days 1 to 28) and P, 300 mg/day vaginally (cycle days 15 to 28). After a menstrual cycle washout interval, women received a similar treatment except that 17beta-E(2) was administered vaginally. MAIN OUTCOME MEASURE(S): Endometrial thickness, mean uterine artery pulsatility index, endometrial blood flow, and uterine contraction frequency assessed in ultrasound scans on cycle days 14 and 18. RESULT(S): On day 14, the endometrium was thicker (8.7 +/- 0.6 vs. 7.1 +/- 0.3 mm, P< .0001), pulsatility index values were lower (2.4 +/- 0.1 vs. 3.0 +/- 0.2, P< .0002), and endometrial blood flow tended to be increased in the vaginal E(2) cycles as compared to the oral E(2) cycles. On day 18, similar differences remained. However, P-induced decrease in contraction frequency was slighter in vaginal E(2) cycles (33% vs. 18%, P< .0003). CONCLUSION(S): Vaginal E(2) administration improves endometrial proliferation and uterine perfusion, presumably because of combined local and systemic effects, but may interfere with P-induced uterine relaxation.

Administration, Intravaginal↗
PubMed1989

Effectiveness of vaginal bromocriptine in treating women with hyperprolactinemia.

Treatment of hyperprolactinemia with oral bromocriptine has been associated with a high incidence of side effects. The authors recently demonstrated that, in normal women, the vaginal route of administration was an effective and safe alternative to oral bromocriptine. To evaluate the effectiveness of vaginal bromocriptine in treating women with hyperprolactinemia, the authors treated 15 hyperprolactinemic women with daily vaginal administration of 2.5 mg tablets of bromocriptine. Serum prolactin (PRL) levels and vital signs were measured daily for 6 days, then weekly for 4 weeks. Gastrointestinal side effects were limited to a single episode of mild nausea, and two cases of transient constipation. In all patients there was a dramatic initial reduction in PRL in response to a single 2.5 mg dose of bromocriptine. In 13 patients PRL levels were maintained within the normal range with daily administration of 2.5 mg, whereas in two patients, PRL levels remained higher than normal despite an increase in bromocriptine dose to 5 mg. These results suggest that short term use of vaginal bromocriptine is a safe and effective method of therapy for hyperprolactinemia.

Administration, Intravaginal↗
PubMed1989

Estradiol and progesterone replacement regimens for the induction of endometrial receptivity.

Initiation of pregnancy in premature ovarian failure patients by use of donated oocytes fertilized in vitro requires establishment of a normal endometrial environment. We compared administration of estradiol (E2) and progesterone (P) by polysiloxane vaginal rings versus oral micronized E2 and P vaginal suppositories in 10 such patients. Serum E2 levels were similar between groups and similar to normally-cycling controls. With vaginal administration of E2, a burst effect was noted, with marked elevation 1 hour after insertion. The pattern with oral administration was more consistent, although marked conversion to estrone occurred. The P cylinder and suppositories delivered similar levels, with diminution of P in some patients with the cylinder. Despite apparent limitations, endometrial histology was normal after each cycle; both groups achieved pregnancies. Administration of E2 and P by polysiloxane vaginal rings achieved hormonal levels similar to oral micronized E2 and P vaginal suppositories. Endometrial biopsies after the stimulated cycle were appropriately mature.

Absorption↗
PubMed1998

Experience with a novel vaginal progesterone preparation in a donor oocyte program.

OBJECTIVE: To compare the efficacy of a vaginal progesterone preparation with our standard IM preparation within a donor egg program. DESIGN: Prospective randomized trial. SETTING: Donor egg program at a university assisted reproductive therapy program (Jones Institute for Women's Health). PATIENT(S): Couples accepted into the donor egg program because of either premature ovarian failure or evidence of diminished ovarian reserve. INTERVENTION(S): Women were randomized into either a group receiving IM progesterone replacement or a group receiving vaginal progesterone replacement. Both groups underwent Estraderm patch/progesterone treatment in a mock cycle leading to an endometrial biopsy on day 26 followed by a second cycle in which ET was performed. Subjects with residual ovarian function received a GnRH agonist. In the IM treatment group, 100 mg was administered from cycle days 15 to 27. In the vaginal treatment group, Crinone 8%, a polycarbophil-based gel preparation containing 90 mg of micronized progesterone, was administered twice daily from the evening of day 14. MAIN OUTCOME MEASURE(S): Endometrial histology, serum levels of progesterone (on days 13, 17, 20, 24, and 26), the occurrence of pregnancy, implantation rate, and pregnancy outcome. RESULT(S): Fifty-four women randomized into the vaginal progesterone treatment group and 18 women in the IM treatment group achieved ET. Mean serum progesterone levels were higher in the IM treatment group than in the Crinone group. Endometrial histology was "in phase" for all subjects in both groups. Clinical pregnancies were observed in 26 of 54 women and 5 of 18 women in the Crinone and IM progesterone groups, respectively. The ongoing pregnancy rate (PR) of 31% (17/54) and implantation rate of 23% in the subjects receiving Crinone was not statistically different from the IM progesterone group's ongoing PR of 22% (4/18) and implantation rate of 18%. CONCLUSION: Vaginal progesterone replacement with the polycarbophil gel preparation was as effective as IM progesterone in producing clinical and ongoing pregnancies within our donor egg program in the dosages administered.

17-alpha-Hydroxyprogesterone↗