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PubMed1986

Parity and use-effectiveness with the contraceptive sponge.

The results of a randomized United States study indicated that the Today contraceptive sponge was less effective than the diaphragm (1-year cumulative life-table rate of 17.4 versus 12.9 pregnancies per 100 women, p = 0.01). However, this overall comparison is misleading. Using univariate and multivariate analyses to account for the effects of user characteristics we found parity to be the most important single determinant of effectiveness for users of the sponge, but parity was unimportant as a risk factor for pregnancy among diaphragm users. For nulliparous women the sponge was as effective as a physician-prescribed barrier method (13.9 for sponge, 12.8 for diaphragm, p = 0.45); however, parous women using the sponge were twice as likely to become pregnant (28.3 for sponge, 13.4 for diaphragm, p = 0.001). The effect of parity among sponge users is consistent with the results of international studies of the contraceptive sponge.

Adult↗
PubMed1985

Use of the Today contraceptive sponge in the United States.

Use of the TODAY contraceptive sponge in the U.S. has been monitored in three ways since it became an OTC product in June, 1983: The Phase III clinical trials in the U.S. were extended for a second year (Life Table method efficacy rate for a second year of use = 96.6%; N = 103). The manufacturer has solicited comments and complaints from family planning professionals and from women who purchased sponges over-the-counter. One complaint has been received for every 33,000 sponges distributed, primarily related to removal difficulty, infection and allergy to spermicide. By December of 1984, there were an estimated 1.25 million sponge users in the U.S. Voluntary, spontaneous reporting to regulatory or health agencies has tracked case reports of toxic shock syndrome (TSS) in sponge users. To date 13 cases have been reported with over 25 million sponges sold. The risk of TSS in sponge users is thus very small and may not represent an increased risk over baseline.

Actuarial Analysis↗
PubMedDate not supplied

Contraceptives for teenagers.

The contraceptive options suitable for teenagers are presented and discussed. Condoms have the advantage of preventing the spread of sexually transmitted diseases, and oral contraceptives are probably the most effective in preventing pregnancy. Other options include the barrier contraceptives available to women, spermicides, sponges, intrauterine devices, periodic abstinence, and the morning after pill.

Adolescent↗
PubMed1987

Updated pregnancy rates for the Today contraceptive sponge.

Pregnancy rates (method and user) were evaluated for 2245 women who participated in the phase III clinical trials of the Today contraceptive sponge. User and method pregnancy rates were similar for women of different ages and parities. The 1-year method and user pregnancy rates (life table per 100 women) were 8.2 and 5.6, respectively.

Clinical Trials as Topic↗
PubMedDate not supplied

Contraceptive efficacy of the diaphragm, the sponge and the cervical cap.

A reanalysis of data from two clinical studies--in which 1,439 women were randomly assigned to use either the contraceptive sponge or the diaphragm and 1,394 women were randomly assigned to use either the cervical cap or the diaphragm--found first-year probabilities of failure during typical use of 17% for the sponge, 18% for the cervical cap and 13-17% for the diaphragm. The first-year probabilities of failure during perfect use are 11-12% for the sponge, 10-13% for the cervical cap and 4-8% for the diaphragm. The probability of failure during perfect use is significantly higher among women who have given birth than among those who have not for users of the sponge (19-21% vs. 9-10%) and users of the cervical cap (26-27% vs. 8-10%), but not for users of the diaphragm.

Contraceptive Devices, Female↗
PubMed1984

Barrier contraception.

Barrier contraception is a safe, effective, reversible form of contraception acceptable to many couples. The use of barrier contraception may protect against carcinoma of the cervix and sexually transmitted diseases. Distribution and education in the use of barrier contraception does not always require medical supervision. This must make it an attractive form of contraception for agencies supporting family planning programmes in developing countries. The only marketed recent advance in barrier contraception is the collatex sponge. Effectiveness rates range between 9 and 27 pregnancies per 100 woman-years. This is unlikely to make it the first choice of contraception for couples who would find an unintended pregnancy a severe problem, but the sponge will be acceptable to couples who are simply trying to delay a pregnancy. The new surge of interest in barrier contraception could lead to safer more effective forms of contraception being made available to women without medical supervision. This would have many advantages, but could also detract from the ability of family planning clinics to play an important role in preventative medicine for women.

Adrenergic beta-Antagonists↗
PubMed1990

Frequency of use, knowledge, and attitudes toward the contraceptive sponge among inner-city black and Hispanic adolescent females.

This study assessed the frequency of use, knowledge, and attitudes toward the contraceptive sponge in sexually active, inner-city, black and Hispanic adolescent females. A 54-item, self-administered questionnaire was completed by 208 adolescents (mean age 17.9 years) attending a gynecology/family planning clinic within a comprehensive adolescent health center. Twenty-nine (13.9%) had never used any birth control, and 49 (23.6%) had not used any form of birth control in the 3 months prior to the study. Fifty-three (25.5%) of the adolescents had used a less reliable method such as rhythm and/or withdrawal. The birth control method used least was the sponge. Only four (1.9%) of the adolescents had used the sponge in the 3 months prior to the study, and only ten (4.8%) had ever used it. Knowledge of the correct use of the sponge was poor. However, 69 (44.8%) of the 156 girls who knew about the sponge had a positive attitude toward it, and only 19% said they did not like it. The contraceptive sponge may be a viable option for adolescents, particularly those who are not using birth control or who are using a less reliable method.

Adolescent↗
PubMedDate not supplied

The contraceptive sponge's protection against Chlamydia trachomatis and Neisseria gonorrhoeae.

To investigate the effect of the contraceptive sponge on the incidence of sexually transmitted diseases, we conducted a clinical trial among a high-risk population of women in Bangkok, Thailand. Two hundred fifty-five women were randomly assigned either to use the sponge or not and were evaluated weekly for gonorrhea and chlamydial infection. After adjustment by logistic regression for potentially confounding factors, women using the sponge were less likely to have contracted chlamydial infection (odds ratio [OR], 0.6; 90% confidence interval [CI], 0.4-1.0) and gonorrhea (OR, 0.9; CI, 0.6-1.3) as compared with women not using the sponge. These estimates probably underestimate the degree of protection because some exposure was misclassified in this pilot phase of the study. These results are consistent with other studies indicating that spermicides protect against gonorrhea and also demonstrating protection against an organism of even greater public health concern, Chlamydia trachomatis.

Adult↗
PubMed2000

An acceptability study of female-controlled methods of protection against HIV and STDs in south-western Uganda.

We aimed to assess the acceptability of a variety of formulations of female-controlled methods of protection against HIV and STDs among men and women in south-western Uganda. Pilot interviews were carried out with 50 men and 55 women and 25 focus group discussions (FGDs) were held with 138 women and 42 men. The female condom, foaming tablets, sponge, foam, gel and film were demonstrated to 146 women and 35 of their male partners, who then tried out 2 of the products. They were interviewed 7 times during the course of 5 months. At the end experiences were evaluated during a second series of FGDs. Sixty-five (45%) women completed the trial. The main reasons for non-completion were related to geographical mobility. Product preference after the initial demonstration was similar to that at the end of the trial. The most popular formulations were the sponge (25% of the women), foaming tablets (23%), and the female condom (19%). The foam was of medium popularity (16%). The gel (9%) and film (7%) were least popular. Ten per cent of the women and 14% of the men reported products interfering with sexual enjoyment; 24% of the women and 67% of the men said products increased enjoyment. 'Dry sex' is not popular in this area and increased lubrication was an important determinant of acceptability. Age, level of education and location did have some effect on preference. Although secrecy was a dominant theme in the FGDs, 87% of the women had informed their partners by the end of the trial. The products were generally well received. Female control was an important issue for both sexes. Male attitudes were ambivalent because female ownership of products increased women's control. Although they have clear preferences, women appear to accept the products generally and might use a single available product just as readily if choice was limited, as long as it conforms to general cultural preferences, such as those relating to wet/dry sex.

Adolescent↗
PubMed2005

Administration of 6-methoxybenzoxazolinone (MBOA) does not augment ovulatory responses in St. Croix White ewes superovulated with PMSG.

The objective of this investigation was to examine the effects of 6-methoxy-benzoxazolinone (MBOA), a plant compound that resembles melatonin and alters ovarian function in rodents, in combination with PMSG on superovulatory responses in the cycling ewe. In Experiment I, St. Croix White ewes (n = 44) were synchronized (intra-vaginal progestin sponge) for 14days followed by hCG (750 IU) at 1 day after sponge removal (day 0). Ewes were assigned to one of six treatments administered on day -1: Control (no PMSG or MBOA; n = 7); PMSG (1000 IU i.m.; n = 7); Low MBOA (0.43 mg/kg i.m.; n = 7); High MBOA (1.15 mg/kg i.m.; n = 7); Low MBOA + PMSG (n = 8); High MBOA + PMSG (n = 8). In Experiment II, St. Croix White ewes (n = 24) were synchronized (progestin CIDR) for 14 days followed by hCG on day 1 after CIDR removal (day 0). Ewes were assigned to one of three treatments administered on day -1: Control (n = 8); PMSG (n = 8); Low MBOA+PMSG (n = 8). Laparoscopy was performed on day 9 to assess numbers of corpora lutea (CL) and visible follicles on each ovary. Blood samples were collected on day -13, -1, 0, 1, and days 6 or 7-12 for analysis of serum progesterone (P4) by RIA. Treatment groups receiving PMSG (alone or with MBOA) exhibited greater (P < 0.05) serum concentrations of P4 post-synchrony than Control and MBOA-only groups. Ovulation rate was lower (P < 0.05) for Control and MBOA-only treated ewes than ewes receiving PMSG. Ovulation rate in ewes treated with MBOA alone was similar (P > 0.10) to Controls, and PMSG treatment alone did not differ (P > 0.10) from MBOA + PMSG treatment. Ewes treated with PMSG alone did not differ (P > 0.10) in follicle number from High MBOA + PMSG treated ewes, however, Low MBOA + PMSG treated ewes had greater numbers of follicles at day 9 (P < 0.05) than the PMSG or High MBOA + PMSG groups in Experiment I; although, this was not replicated in Experiment II with numbers of follicles in the Low MBOA + PMSG group being similar (P > 0.10) to PMSG alone. In summary, the addition of MBOA in combination with PMSG as part of a synchronization-superovuation protocol in the ewe did not increase ovulation rate.

Animals↗
PubMed1986

Clinical evaluation of drugs used in fertility regulation.

The clinical evaluation of drugs used in fertility regulation is initially assessed in Phase I, II and III trials. The design of each phase and the investigative staff must be adequate. In Phase I, normal, healthy human volunteers meeting specific guidelines are usually studied. Numbers vary between 20 and 80 and the purpose is to determine the acute toxicity of the compound. In Phase II, efficacy and safety are examined in a clinical target population, and emphasis may be placed on pharmacological and mechanistic studies. Usually between 50 and 200 patients are involved. In Phase III, large-scale clinical studies for local registration and the introduction of drugs to various countries are included. This paper describes the evaluation of various drugs used in contraception, including NORPLANT implants, and considers the efficiency, safety and acceptability of such drugs. Phase IV studies are usually needed to reveal chronic toxicities or rare events.

Clinical Trials as Topic↗
PubMed1991

Further characterization of the electromyographic activity of the myometrium and mesometrium in nonpregnant sheep under estrogen supplementation.

The effects of estrogen administration on uterine contractility varies with animal species. In nonpregnant ovariectomized sheep, estrogen administration has been reported either to inhibit, inhibit then stimulate, or only stimulate uterine contractility. The aim of the present study was to determine the effects of prolonged estrogen administration in the electromyographic (EMG) activity recorded from the myometrium and mesometrium in nonpregnant ovariectomized sheep after estrous synchronization by inserting vaginal progesterone sponges 14 days before surgery. Surgery was performed on four ewes under halothane anesthesia. Bilateral oophorectomy was performed, and stainless steel EMG electrodes were sewn to the mesometrium and myometrium in both left and right horns of the uterus. Blood samples were taken at 1000 h from the uterine vein for 13,14-dihydro-15-keto-prostaglandin F2 alpha determination, and from the femoral artery for estradiol determination. Starting on Day 7 after surgery, estradiol 17 beta (50 micrograms/24 h) was infused continuously into the jugular vein. Estrogen administration had a different effect on the EMG activity recorded from myometrium and mesometrium. The myometrial response to estrogen was an increase in the frequency of short EMG events from 19.0 +/- 8.7 to 57.0 +/- 5.0 (p less than 0.05) for events less than 60 sec, and from 2.70 +/- 0.83 to 10.30 +/- 1.36 (p less than 0.05) for events lasting greater than 60 sec but less than less than 180 sec. In contrast, there was no stimulatory effect of estrogen on mesometrial EMG for both types of short events less than 60 sec, and greater than 60 but less than less than 180 sec.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗