Acceptability of two spermicides in five countries.

Data from a large, international, multicenter, randomized trial were analyzed to compare the acceptability of two nonoxynol-9 spermicide preparations. Women who wished to use a spermicide for contraception were randomly assigned to use either a foaming tablet (n = 383) or a nonoxynol-9 film (n = 382) for 28 weeks as their only method of contraception. Participants completed questionnaires about acceptability of the assigned product 4 weeks after admission and at discontinuation. Women in both groups had very favorable opinions of the spermicide. The proportion of women who said that they liked their assigned product very much was 50% in the tablet group and 55% in the film group. Significantly more women in the film group rated the spermicide difficult to insert and stated that the product stuck to the finger during insertion. More women in the tablet group said that the product was messy and that, at least once, it did not dissolve. In both groups, liking the product was significantly associated with consistency of use, but not with subsequent pregnancy. Participants' male partners had little influence on participants' opinions about, or use of, the spermicides. Although previous analyses showed that both spermicides are associated with high pregnancy rates, they are both highly acceptable to most women.

PIP: This study compares the acceptability of two nonoxynol-9 spermicide preparations in Mexico, Ecuador, Guatemala, Ghana and the US. A total of 765 women (383 using a foaming tablet and 382 using nonoxynol-9 film for 28 weeks) were enrolled. Participants completed a questionnaire about acceptability of the assigned product, 4 weeks after admission and at discontinuation. Result of the trial revealed that women in both groups had very favorable opinions of the spermicide. The proportion of women who said that they liked their assigned product very much was 50% in the tablet group and 55% in the film group. Significantly more women in the film group rated the spermicide difficult to insert and stated that the product stuck to the finger during insertion. More women in the tablet group expressed that the product was messy and that, at least once, it did not dissolve. In both groups, liking the product was significantly associated with consistency of use, but not with subsequent pregnancy. Participants' male partners had little influence on participants' opinions about, or use of, the spermicides. Although previous analysis showed that both spermicides were associated with high pregnancy rates, they were both highly acceptable to most women.

Study of the vaginal tolerance to Acidform, an acid-buffering, bioadhesive gel.

Vaginal tolerance tests were performed with a new potential microbicidal and spermicidal product, an acid-buffering vaginal gel (Acidform) without or with nonoxynol-9 (N-9). The potential advantages over other vaginal products include keeping a low pH, decrease of the irritating effect of N-9 on the cervix or vaginal mucosa associated with greater retention of the product after application, and decreasing "messiness" as compared to other vaginal products. Three groups of six women were admitted and randomly assigned to use Acidform with 0%, 2.5%, and 5% N-9. Colposcopic evaluation for vulvar, vaginal, and cervical signs of irritation was performed and photographs were taken, following a specific World Health Organization protocol, at time 0, and after 24 h and 6 days of application of the gel. No irritation or symptom was reported by users of Acidform without N-9. A generalized and intense erythema in cervix was observed in 10 of 12 Acidform/N-9 users and abrasion occurred in nine of them. Vulvar irritation was seen in seven of these 10 volunteers. N-9 concentration in the gel (2.5% or 5.0%) was not related to the findings. No ulcer, exulceration, or de-epithelialization was observed. Acidform without N-9 was well tolerated by volunteers, but it was unable to protect the cervix, vagina, and vulva from the N-9 effects.

Use of spermicide and impact of prophylactic condom use among sex workers in Santa Fe de Bogota, Colombia.

BACKGROUND AND OBJECTIVES: Condom use is one of the most important preventive measures sex workers can take to reduce the risk of becoming infected with a sexually transmitted disease. However, a client may refuse to use a condom when requested. Some sexually transmitted disease prevention programs are recommending that sex workers use spermicide as an alternative prophylaxis when a condom is refused, yet little is known about the effect of this recommendation on prophylactic condom use. GOAL: To determine if using spermicide, either in conjunction with condoms or as a backup, influenced overall condom use among a group of sex workers at high risk of sexually transmitted diseases in Santa Fe de Bogota, Colombia. STUDY DESIGN: Participants were assigned randomly to one of three condom use groups: use of condoms only (Condoms Only), use of condoms and spermicides concurrently (Condom and Spermicide), or use of spermicide when condoms were refused (Spermicide as a Backup). A total of 199 sex workers entered the study and were asked to return for follow-up every 2 weeks for a period of 12 weeks. RESULTS: Women assigned to the Spermicide as a Backup group used a condom for an average of 78.1% of their reported acts of intercourse, compared with an average of 94.5% in the Condom Only and 92.3% in the Condom and Spermicide groups. However, women in the Spermicide as a Backup group used a condom or spermicide for an average of 96.9% of their acts of intercourse. Condoms were used for every intercourse act by less than 5% of the women in the Spermicide as a Backup groups, compared with 50.7% in the Condom Only group and 41.2% in the Condom and Spermicide group (P 0.001). When condoms were not used, client refusal was the primary reason reported. The incidence of sexually transmitted diseases and other urogenital inflammations in all groups was lower than expected. CONCLUSIONS: Among Colombian sex workers, condom use declined substantially when women were instructed to use spermicides if they were unable to persuade their partner to use a condom. However, these same women usually used the study spermicide as an alternate prophylaxis.

PIP: Some sexually transmitted disease (STD) prevention programs recommend that prostitutes use spermicide as an alternative prophylaxis when a condom is refused. 199 female sex workers in Santa Fe de Bogota, Colombia, participated in a study to assess the effect of this recommendation upon condom use. Women were randomly assigned to use condoms only, use condoms and spermicides concurrently, or use spermicide when condom use was refused. They were instructed to return for follow-up every 2 weeks for 12 weeks. Women in the spermicide-as-a-backup group used a condom for an average of 78.1% of reported acts of intercourse, compared to an average of 94.5% among the condom-only users and 92.3% among the women instructed to use both condoms and spermicide. Women in the spermicide-as-a-backup group used either a condom or spermicide for an average of 96.9% of their acts of intercourse, but less than 5% used a condom for every act of intercourse. 50.7% of women in the condom-only group and 41.2% in the condom/spermicide group used a condom for every act of intercourse. There was a lower than expected incidence of STDs and other urogenital inflammations in all groups.

Comparative study on intermittent versus continuous use of a contraceptive pill administered by vaginal route.

A multicenter, international, randomized, comparative trial was conducted to assess the acceptability, efficacy and safety of two different schedules of a contraceptive pill, containing 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol, administered by the vaginal route. One schedule of daily administration for 21 days with a seven-day interruption to allow withdrawal bleeding was compared to daily administration without interruption for bleeding. A total of 900 women were recruited in three countries, Brazil, Egypt and China; 7,090 women-months of vaginal pill use were recorded (3,364 using the pills intermittently and 3,726 continuously). Four undesired pregnancies occurred, one in Egypt and three in China, all four in women using the pills intermittently. There was a statistically significant difference (p = 0.486) in pregnancy rate between the two groups. There were no other significant differences in discontinuation rates despite marked differences in bleeding patterns, amenorrhea predominating in the continuous use group. Hemoglobin levels increased significantly in the two groups but hematocrit was significantly higher in the continuous use group.

PIP: 900 healthy women 16-42 years old were recruited in Brazil, China, and Egypt for a multicenter, randomized, comparative clinical trial to determine the acceptability, efficacy, and safety of two different schedules of a contraceptive pill with 250 mcg levonorgestrel and 50 mcg ethinyl estradiol administered vaginally. The two schedules were: 1) daily vaginal use of the pill for 21 days, followed by withdrawal for regular bleeding, and restarted 7 days later, and 2) use of the pill by the vaginal route nonstop for one year. There were no significant difference in cumulative discontinuation rates between the two groups (total, 15.5 for intermittent group and 14.64 for continuous group), except for unwanted pregnancy. The only unwanted pregnancies occurred to 4 women in the intermittent group (1.04%) (p = 0.0486). Women in the continuous use group were more likely than those in the intermittent group to have spotting at least once (20.6% vs. 4.4%; p 0.001). Women in the continuous group were more likely than those in the intermittent group to have amenorrhea. For example, the mean number of bleeding/spotting days during all time intervals was lower for the continuous group than for the intermittent group (p 0.001; last interval, 0.97 vs. 12.83). Hemoglobin levels increased considerably in both groups between baseline and one year of use (11.61 vs. 11.9 g/dl for intermittent group and 11.54 vs. 11.81 g/dl for continuous use; p 0.001). The mean value of hematocrit at 12 months for the continuous group was higher than that at baseline (38.8% vs. 38.2%; p = 0.011). It did not increase in the intermittent group, however. Women in both groups gained weight during the 12 months of pill use. The weight gain was significant for the continuous group only. These findings suggest that continuous use of vaginal contraceptive pills may be more advantageous than intermittent use oral contraceptives and may benefit anemic women and those who bleed heavily during menstruation.

Effectiveness of the diaphragm, used continuously, without spermicide.

The experience of 670 diaphragm users from three Brazilian clinics was retrospectively reviewed. Most of the subjects (441) followed the traditional method (TM) of using the diaphragm, only at the time of sexual intercourse and with spermicide. One third (215) used the diaphragm continuously (CU), without spermicide, removing it only at the time of their daily shower to wash it, with immediate re-insertion. The total pregnancy rate was 7.0 per 100 women-years for the whole group. Patient and total failure rate were significantly lower in the CU (0.6 and 2.8), in comparison with the TM sub-group (6.5 and 9.8). The discontinuation rate for urinary infection or other medical reasons was not greater in the CU group. Logistic regression analysis, including age, parity, number of abortions and of living children, years of schooling, whether living with a partner, presence of mild cystocele or retroverted uterus, and form of use of diaphragm (TM or CU), showed that only the TM of diaphragm use was positively associated to patients' and total failure rate.

PIP: In Brazil, a retrospective review of clinical records of diaphragm users from the Sexuality and Health Women's Collective in central Sao Paulo, the family planning clinic at the State University of Campinas, and a private practice in Belo Horizonte was performed to compare data on 215 women continuously using it without spermicide, except to clean it during a shower, with data on 441 women using it with spermicide only during sexual intercourse to determine diaphragm effectiveness. The patients' failure rate stood considerably higher among women using the diaphragm with spermicide (6.5 vs. 0.61; p .05). The method failure rate was just slightly higher in the diaphragm with spermicide users' group (3.53 vs. 2.2). 71.47% of all women continued use for 12 months, especially women continuously using the diaphragm without spermicide (84.84 vs. 63.28%; p .05). Women who used the diaphragm with spermicide were more likely to discontinue for vaginal discharge and for other medical and personal reasons than were those who continuously used it without spermicide (p .05). They were also more likely to be lost to follow up (16.4% vs. 6.43%; p .05). The logistic regression analysis indicated that diaphragm with spermicide use was positively linked to patients' and total failure (p = .042). These findings suggested that the messiness of diaphragm use with spermicide, its interference with sexual intercourse, and perhaps spermicide cost contributed to its high discontinuation and failure rates. The findings should raise interest in identifying means to improve acceptance of and use effectiveness of the diaphragm.

A dosing study of nonoxynol-9 and genital irritation.

The objective of the study was to assess the symptoms and signs of genital irritation produced by different frequencies of nonoxynol-9 (N-9) use. Thirty-five women were randomized to each of 5 groups and used a vaginal suppository for 2 weeks. Group 1: N-9 once every other day; Group 2: N-9 once a day; Group 3: N-9 twice a day; Group 4: N-9 4 times a day; and Group 5: placebo 4 times a day. Study women were examined at admission, one week and 2 weeks with a colposcope for erythema and epithelial disruption, and were interviewed about vaginal itching and burning. The rates of reported symptoms for N-9 users were not significantly different from that of placebo users. The rate of epithelial disruption for women using N-9 every other day was essentially the same as that of women using placebo. The rates of epithelial disruption for women using N-9 1/day and 2/day were 2.5 times greater than that of placebo users. The rate of epithelial disruption for women using N-9 4/day was five times greater than that of placebo users. Genital irritation was located primarily on the vagina or cervix, and vulvitis was not a significant problem. Women who infrequently use N-9 products may not experience an increase in genital irritation. Women who choose to use N-9 frequently may experience an increase in epithelial disruption.

Comparative trial between two soft jelly capsules containing nonoxynol as spermicidal contraceptives.

The rupture time of two types of soft jelly capsules (treated and non-treated) containing Nonoxynol-9 after its vaginal insertion was investigated in 96 women. Subjects were allocated in four study groups: Group I (n = 24), women with clinical vaginal infection; Group II (n = 24), subjects without vaginal infection; Group III (n = 24), patients with vaginal infection; and Group IV (n = 24), women without vaginal infection. Groups I and II received the treated capsules, and Groups III and IV the non-treated capsules. The capsules remained in the vagina for 2.5 to 5 minutes. The weight of the capsules was measured before insertion and after their extraction. Additionally, vaginal pH and distribution of the compound were assessed. The results disclosed that in Groups I, III and IV, the capsules ruptured within 2.5 minutes, whereas in Group II the rupture did not occur until 3 minutes. The largest number of non-ruptured capsules was observed in Group II. The major capsule weight loss occurred at minute 5 in most of the groups. The conditions currently observed in cases of non-ruptured capsules were: alkaline pH, multiparity and vaginal dryness. The vaginal distribution of the compound was observed at its upper portion. In women with vaginal infections, there were more cases of rupture and a significant weight loss between the treated capsules than the non-treated capsules. Further postcoital tests are required to assess its effectiveness.

PIP: The rupture time of 2 types of soft jelly capsules (treated and non-treated) containing Nonoxynol-9 after its vaginal insertion was investigated in 96 women in Mexico. Subjects were allocated in 4 study groups: Group I (n=24), women with clinical vaginal infection; Group II (n=24), subjects without vaginal infection; Group III (n=24), patients with vaginal infection; and Group IV (n=24), women without vaginal infection. Groups I and II received the treated capsules, and Groups III and IV the non-treated capsules. The capsules remained in the vagina for 2.5 to 5 minutes. The weight of the capsules was measured before insertion and after their extraction. Additionally, vaginal ph and distribution of the compound were assessed. The results disclosed that in Groups I, III and IV, the capsules ruptured within 2.5 minutes, whereas in Group II the rupture did not occur until 3 minutes. The largest number of non-ruptured capsules was observed in Group II. The major capsule weight loss occurred at minute 5 in most of the groups. The conditions currently observed in cases of non-ruptured capsules were: alkaline ph, multiparity and vaginal dryness. The vaginal distribution of the compound was observed at its upper portion. In women with vaginal infections, there were more cases of rupture and a significant weight loss between the treated capsules than the non-treated capsules. Further postcoital tests are required to assess its effectiveness.

Guatemala social marketing program.

PIP: The Guatemala Social Marketing Program reported 1986 increases after social marketing promotion in the sales of Panther and Scudo condoms, Perla oral contraceptives, and Lirio vaginal foaming tablets. Sale of Panther condoms was highest in February; all the other products peaked in June and July. Sales fell in December due to Christmas holidays. Sale patterns are illustrated graphically for all 4 products.^ieng

FPA withdraws from CSM project in Guatemala.

PIP: Guatemala's family planning association, the Asociacion Pro-Bienestar de la Familia (APROFAM) recently cut its ties with the nation's contraceptive social marketing program. The announced reasons for the disassociation was APROFAM's concerns about the legality of selling donated commodities. APROFAM helped create the program served as a member of the marketing program's board of directors, and was expected to function as the channel for the commidities donated by the US Agency for International Development (USAID). The marketing program will now be managed by the newly created Importadora de Farmaceuticos (IPROFA), a for-profit organization. This alters the legal status of the marketing program, and as a result, the program will be required to pay duties on USAID donated contraceptives. USAID cannot legally pay duties on its own contributions. Instead, the duies will be paid by IPROFA out of the revenues generated by the project. IPROFA will finance the 1st consignment of products with a bank loan, and the loan and duties on subsequent shipments will be paid out of the program's revenues. This strategy is not expected to pose legal problems for USAID, since the agency has no control over how programs use the revenues generated by selling the agency's commodities. As a result of the changed status, the marketing program must acquire it own storage and packaging facilities. According to Manuel DeLucca, the program's resident advisor, these problems will not delay the launch of the program's products scheduled for early 1985. The program plans to sell an oral contraceptive, a vaginal spermicidal tablet, and a condom. Orginal plans called for selling the low dose OC, Norminest; however, Norminest may not be approved for distribution in Guatemala, and USAID may replace Norminest with another product. As a result, the program may market Noriday, a normal dose pill instead of Norminest. Guatemalan registration of the spermicidal tablet the program is planning to sell is pending. The program is engendering considerable interest because of its unique legal status as a commercial enterprise and its freedom from bureaucractic constraints.^ieng

Social marketing program sales.

PIP: A table presents the latest available statistics on social marketing program sales and status in the countries of Bangladesh, the Caribbean, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Jamaica, Mexico, and Nepal. The Bangladesh Family Planning Social Marketing Program was implemented in 1975 and is active at this time. Over the June 1983 to May 1984 period, 87,034,000 Raja condoms, 4,242,000 Panther condoms, 1.157,000, Maya pills, 846,000 Ovacon low-dose pills, and 4,332,000 Joy foaming tablets were sold for 1,109,000 couple years of protection (CYP). Over the March 1984 to May 1984 period, the Caribbean Social Marketing Project, implemented in 1983, sold 16,000 Panther condoms, 1000 Perle pills, and 1000 Perle low-dose pills. Sales are expected to begin in Ecaudor's program in August 1984. Egypt's program is active. Data for July 1983 to June 1984 show that 6,722,000 condoms, 1,988,000 Amman foaming tablets, 114,600 Cu-T IUDs, 66,600 Cu-7 IUDs, and 578,000 Norminest low-dose pills were sold for a total of 515,000 years of protection. Over the March 1983 to February 1984 period, El Salvador's program sold 537,000 Condor condoms, 125,000 Perla pills, and 61,000 Suave foaming tablets for 16,000 CYP. There have been no sales as yet in Guatemala's program. Sales for the Honduras program began in March 1984, but no data are available as yet. India's Nirodh Marketing program was implemented in 1968. For the January 1983 to September 1983 period, 83,140,000 Nirodh condoms were sold for 1,109,000 CYP. Over the May 1983 to April 1984 period, Jamaica's program sold 1,031,000 Panther condoms and 330,000 Perle oral contraceptives for 35,000 CYP. Mexico's Profam, implemented in 1978, sold 6,602,000 condoms, 18,000 pills, and 9000 injectables for 35,000 CYP for the May 1983 to June 1984 period. Nepal's Contraceptive Retail Sales Corporation was implemented in 1976. For the May 1983 to April 1984 period, 2,833,000 condoms, 82,000 Gulaf pills, 15,000 Nilocon low-dose pills, and 167,000 Kamal foaming tablets were sold for a total of 37,000 CYP.^ieng

[Comparative clinical study of 5 barrier methods]. / Estudio clínico comparativo de cinco métodos de barrera.

PIP: The effectiveness and acceptability of 5 barrier methods of contraception were investigated in 171 males and 407 women. They chose the use of ovules with 0.4 mg phenylmercuric acetate; foaming tablets with mephengol; 60 mg ovules with nonoxynol 9, 5.8%; and polymeric sponges with nonoxynol 9 at different concentrations. Anticonceptive effectiveness was evaluated by the Pearl's Index; the lowest rating (6.0) was for the preservative. In decreasing order came mephengol tablets (33.4), phenylmercuric ovules (33.0), nonoxynol ovules (60.7), and polymeric sponges (52.8-120.0). In general the acceptability was low. Discontinuation of spermaticides was due to unreliability; dissatisfaction was the reason for discontinuation of the preservatives and sponges. There were no important side effects. Some couples using foaming tablets reported a sensation of heat as the tablet was dissolving and 2 users reported a bad vaginal odor. After favorable initial acceptance of these methods, final acceptance was low, possibly due to the association with intercourse and direct manipulation of the genitals. (author's)^ieng

The social marketing of contraceptives in Mexico.

PIP: The success in social marketing of the PROFAM brand of subsidized contraceptives, by a nonprofit private institution that supports the Mexican government program, is related here. PROFAM began in 1978, when half of contraceptives were purchased commercially from drugstores: they were neither economical, consistently distributed, nor advertised. Comprehensive market research revealed that a great demand existed. It generated information for choice of items to market, package design, and instructions. In 1979, pills, condoms, foam, cream and vaginal suppositories, all locally produced were distributed. A serious problem initially was the impropriety of using the word "contraceptive" in the media. The first phase of advertising targeted newspapers. After 3 months, 40% of Mexico's drugstores carried PROFAM. The second phase of advertising, in radio, magazines and newspapers, approached consumers with information tailored to the specific socioeconomic group involved. The third phase, geared to rural areas and general stores, concentrates on advantages of each method. Other aggressive aspects of the campaign include house to house sampling and a mail-in question and answer service. Evidence of success in broadcasting the PROFAM message is the frequent reference to PROFAM in jokes in the media and even in graffiti. The government's goal is to reduce the growth rate form 2.9 percent annually to 1 percent by 2000.^ieng