Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial. Contraceptive effectiveness of two spermicides: a randomized trial. A comparative study of the safety, effectiveness and acceptability of two foaming vaginal tablets (nonoxynol-9 versus menfegol) in Thai women. A clinical trial of Neo Sampoon vaginal tablets and Emko foam in Alexandria, Egypt. The efficiency of prostaglandin E2 vaginal suppositories versus intracervical prostaglandin gel for induction of labor in patients with unfavorable inducibility prospects. A clinical trial of nonoxynol-9 for preventing gonococcal and chlamydial infections. A randomized trial of two preparations of vaginal prostaglandin for pre-induction cervical ripening. Efficacy and tolerability of vaginal progesterone capsules (Utrogest 200) compared with progesterone gel (Crinone 8%) for luteal phase support during assisted reproduction. Sequential outpatient application of intravaginal prostaglandin E2 gel in the management of postdates pregnancies.
To estimate and compare the effectiveness and safety of 5 spermicides over 6 and 7 months of use, respectively. The spermicides included 3 gels containing 52.5 mg, 100 mg, and 150 mg of nonoxynol-9 per dose and a film and a suppository, each containing 100 mg of nonoxynol-9 per dose.
                Women wishing to use only spermicide for contraception for 7 months were randomly assigned to use 1 of the 5 spermicides with emergency contraception backup. Participants were followed up for up to 30 weeks after admission.
                Of 1,536 women enrolled, 868 (57%) either relied on the spermicide for 6 months or became pregnant. The probability of pregnancy during 6 months of typical use of the spermicide was 22% (95% confidence limits 16%, 28%) in the 52.5-mg gel group, 16% (10%, 21%) in the 100-mg gel group, 14% (9%, 19%) in the 150-mg gel group, 12% (7%, 17%) in the film group, and 10% (6%, 15%) in the suppository group. The pregnancy risk in the 52.5-mg gel group was significantly different (P <.05) from that in either of the other gel groups. The pregnancy risks in the three 100-mg product groups were not significantly different (P =.35). No significant differences among groups were found in the 7-month probability of specified urogenital conditions.
                The gel with the lowest amount of nonoxynol-9 was less effective than the 2 higher-dose gels. Among 3 products containing 100 mg of nonoxynol-9, formulation did not significantly affect pregnancy risk. All products were safe.
                I We conducted a multinational randomized trial to determine whether a spermicidal film containing 72 mg of nonoxynol-9 per film was at least as effective in preventing pregnancy as a foaming tablet containing 100 mg of nonoxynol-9 per tablet.
                Between September 1995 and July 1997, 765 women aged 18-35 years who had no evidence of subfecundity were randomly assigned to use one of the two spermicides as their only contraceptive method at every coital act for 28 weeks. Participants were asked to keep coital diaries throughout the study period. Pregnancy tests were performed on a scheduled basis. Each participant was followed for 28 weeks or until she stopped considering the spermicide as her primary method of contraception.
                The Kaplan-Meier estimate of the 6-month probability of pregnancy during typical use of the spermicide was 28.0% in the tablet group and 24.9% in the film group (P = .78, one-tailed test). The study had nearly 75% power to have detected a difference of seven percentage points between groups. Results were almost identical when the analysis included only months when the participants reported use of the spermicide during every coital act. Reported levels of sexual activity and compliance with use of the spermicide were high in both groups.
                The contraceptive effectiveness of these two spermicidal products appeared similar. Both products were associated with a fairly high risk of pregnancy in this young, highly sexually active population. Two foaming vaginal tablets containing nonoxynol-9 (OVT-n) or menfegol (OVT-m) were studied to evaluate safety, effectiveness and acceptability. The study was conducted at the Chulalongkorn University, Institute of Health Research, Bangkok, Thailand. One-hundred-two women randomly assigned to one of the two types of tablets were scheduled for follow-up visits at 1, 3, 6 and 12 months. Although there were differences between the two groups in the gross cumulative 12-month life table rates and 12-month continuation rates, these differences were not statistically significant. Twelve-month discontinuation rates for accidental pregnancy were 31.7 per 100 women for OVT-n group and 25.3 per 100 women for the OVT-m group. Seventeen of the total 22 pregnancies occurred due to use failure. This study indicates that the regular and proper use of OVT-n or OVT-m tablets are comparable and are a safe means of birth control. Although a few product-related (burning) or medical complaints were reported by both groups of tablet users, it seems that the vaginal contraceptive is an acceptable method for fertility control in a suitable population who will use it regularly and properly. Results are reported for a comparative 12-month study of Neo Sampoon foaming vaginal tablets containing 60 mg of the spermicide, menfegol, and Emko vaginal foam containing an 8.0% concentration of the spermicide, nonoxynol-9. Conducted in cooperation with the Family Planning Association in Alexandria, Egypt, the trial included 349 women who were randomly allocated to use one of the two contraceptive products. The twelve-month cumulative life-table rate for accidental pregnancy (per 100 women) was 2.8 for Neo Sampoon tablet users and 2.1 for Emko foam users. The 12-month continuation rates were 77.6 and 77.2 per 100 women for the tablet and foam groups, respectively. In both groups, the majority of discontinuations from the study were for personal reasons, including lack of confidence in the method, messiness, partner's objection and a burning sensation. Few women reported a product-related complaint while using their assigned contraceptive method. The most commonly reported complaint for both methods was that use of the product led to an uncomfortable burning sensation for the woman and/or her partner. This complaint, however, was cited by less than 5% of the women in each group. Thus, a combination of low pregnancy rates, few complications and complaints and high continuation rates confirm the relative acceptability, effectiveness and short-term safety of these methods of contraception among this sample of Egyptian women. Two different applications of prostaglandin E2 for induction of labor were randomly used in 113 women with an unripe cervix; 57 women were given prostaglandin suppositories each containing 2.5 mg PGE2 in a basis of Witepsol S55 (Dynamit Nobel), another 56 women were treated with intracervical gel containing 1 mg PGE2 in 5 g hydroxypropylmethyl cellulose. The treatment was repeated after 4 h if the cervix was still unripe, and the procedure was repeated the following day if the cervix was still unfavorable. Cesarean sections was performed within 48 h after the start of induction and before the second stage of labor in 8 women in the suppository group and 7 women in the intracervical gel group. Of the remaining 98 women, 73% (34/48 women) in the suppository group and 36% (18/50 women) in the cervical gel group had delivered within 24 h (p less than 0.01). After 48 h, 88% (42/48 women) in the suppository group and 74% of the women (37/50 women) in the cervical gel group had delivered (p greater than 0.05). The induction-delivery interval in the suppository group was half that found in the cervical gel group. There was no significant difference between the two groups in the use of instrumental vaginal deliveries and cesarean sections nor was there any difference with regard to fetal distress. The post-delivery condition of the newborn was similar in the two groups. No side-effects were reported in either of the two groups. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the spermicidal agent nonoxynol-9 as prophylaxis for cervical infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae. Eight hundred eighteen women were recruited from a sexually transmitted disease clinic. Only subjects who were using reliable birth control methods (oral contraceptives, intrauterine device, or sterilization) were eligible. Subjects were randomly assigned to use either a commercially available spermicidal agent containing nonoxynol-9 or a placebo preparation. Subjects were followed up for six months; specimens were collected monthly for culture of the two pathogens. Women assigned to the nonoxynol-9 group were less likely to become infected with N. gonorrhoeae (relative rate, 0.75; 90% confidence limits, 0.58 and 0.96) and C. trachomatis (relative rate, 0.79; 90% confidence limits, 0.64 and 0.97). Among women who used their assigned gel for the majority of coital episodes, a stronger protective effect was observed. To compare two prostaglandin (PG) E2 preparations for pre-induction cervical ripening in a randomized clinical trial.
                Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women. Outcomes assessed were induction failure, need for labor augmentation, pain relief requirements, fetal heart rate (FHR) abnormalities, operative delivery rate, induction-to-delivery interval, neonatal condition, and occurrence of uterine hyperstimulation.
                There was no statistical difference in pre- and post-dose cervical scores. Compared with the tablet group, women in the gel group were more likely to have significant FHR abnormalities in early labor (odds ratio [OR] 4.77, 95% confidence interval [CI] 1.15-19.5) requiring cesarean delivery. Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group (chi 2 = 4.31, P < .05). Compared with the gel group, women in the tablet group were significantly more likely to require operative delivery for poor progress in labor (OR 2.83, 95% CI 1.20-7.24). Other clinical outcomes were identical, with no significant differences in the overall rate of failed induction, cesarean delivery, rate of assisted delivery, requirement for oxytocin infusion, induction-to-delivery interval, pain relief requirements, or neonatal condition.
                When compared with the PGE2 tablet, the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome. Whereas the gel was associated with an increase in significant FHR abnormalities, the tablet was associated with an increase in the rate of operative delivery for poor progress in labor. To demonstrate the comparative efficacy and tolerability of capsules containing 200 mg of P (Utrogest 200) or Crinone 8% gel for luteal phase and early pregnancy support during assisted reproduction techniques (ART).
                Prospective, multicenter, randomized, controlled, open, parallel-group Phase III trial.
                Seventeen German IVF centers.
                Four hundred thirty women who underwent their first IVF or intracytoplasmic sperm injection cycle were randomized after successful transfer of two or three embryos from July 1999 through September 2001.
                Patients vaginally applied capsules containing 200 mg of P (Utrogest 200) three times per day or containing Crinone 8% gel twice per day. Therapy was started in the evening of the ET day and continued up to 10 weeks in pregnant women. If the pregnancy test proved to be negative, application was stopped.
                Ongoing pregnancy rate at the end of the study (12th week of gestation). Secondary outcomes were rate of implantation and abortion, number and reasons of withdrawals, as well as adverse events, assessment of tolerability, and acceptance.
                There were no relevant differences in demographic and other characteristics between the two groups. Ongoing pregnancy rates were 25.2% in the Utrogest 200 group and 22.2% in the Crinone 8% group when patients were analyzed who normally completed the trial. In the Utrogest 200 vs. the Crinone 8% group, the implantation rate (14.7% vs. 11.9%) and abortion rate (18.2% vs. 19.1%) were not statistically different. The rate of withdrawals at the individual visits also did not differ between treatment groups. Tolerability of both drugs was good, and very few study drug-related adverse events were observed in both groups.
                The luteal phase support in ART cycles with Utrogest 200 capsules (three times per day) or Crinone 8% gel (two times per day) by the vaginal route resulted in similar outcomes with respect to implantation, ongoing pregnancy, and abortion rates. The two recommended regimens of P supplementation in ART proved to be equivalent and safe. A randomized blinded investigation was undertaken to determine the efficacy and safety of sequentially applied intravaginal prostaglandin E2 (PGE2) gel for accelerating cervical ripening in an outpatient setting in low-risk prolonged pregnancies. Fifty women with uncomplicated pregnancies at or beyond 41 weeks' gestation and Bishop scores below 9 received twice-weekly outpatient administration of gel containing 2.0 mg of PGE2 or placebo. Thirty nulliparas and 20 multiparas were enrolled. The PGE2 gel failed to improve cervical ripening over placebo, as judged by Bishop scores. There was no difference between the groups in gestational age on admission to the labor and delivery suite, number of gel applications, requirement for oxytocin, incidence of cesarean delivery, or neonatal outcome. Only two patients (4%) experienced regular uterine contractions after gel insertion; these subsided spontaneously in both. None of the subjects experienced labor, tetanic contractions, evidence of fetal distress, or any other side effects related to gel insertion. We conclude that PGE2 gel in this dosage may be used safely in an outpatient setting, but more frequent application or earlier initiation may be required to produce a clinical effect.
The probability of pregnancy varied widely in reported trials. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial. Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. Gel was liked more than the film or vaginal suppository in the largest trial. Spermicide trials have the dual challenges of difficult recruitment and high discontinuation rates; the latter threatens trial validity.