OBJECTIVES:To assess safety and acceptability of penile application of BufferGel (ReProtect, Baltimore, MD) and PRO 2000 Gel (Indevus Pharmaceuticals, Lexington, MA)compared with placebo among ...low-risk sexually abstinent men and HIV-positive sexually abstinent men.
DESIGN:Seventy-two healthy low-risk men (36 uncircumcised) and 25 HIV-positive men (12 uncircumcised) were enrolled in 3 double-blind, single-center studies as follows36 low-risk men in a study of BufferGel and K-Y Jelly (McNeil-PPC, Skillman, NJ) placebo; 36 low-risk men in a study of PRO 2000 Gel and vehicle placebo; and 25 HIV-positive men in a crossover study of BufferGel, PRO 2000 Gel, and K-Y Jelly placebo.
METHODS:Participants applied product to the penis on 7 consecutive nights, kept study diaries, and were then interviewed and examined. Urine was tested for inflammation by leukocyte esterase.
RESULTS:No serious adverse events (AEs) or urethral inflammation was detected. During use of BufferGel, 3 low-risk men (13%) reported 6 AEs and 2 HIV-positive men (8%) reported 3 AEs. During use of PRO 2000 Gel, 4 low-risk men (17%) reported 6 AEs and 1 HIV-positive participant (4%) had 1 AE. AE rates during use of BufferGel and PRO 2000 Gel use were not significantly different from rates observed during placebo. One low-risk man (4%) would object to his partners using BufferGel and 3 (13%) to PRO 2000 Gel. Two HIV-positive men (8%) reported they would object to partners using either BufferGel or PRO 2000 Gel.
CONCLUSIONS:Daily application of BufferGel and PRO 2000 Gel directly to the penis consecutively for 7 days was generally safe and well tolerated among healthy low-risk men and HIV-positive men. These microbicides have acceptable safety profiles to proceed with planned phase 3 vaginal microbicide trials.
To examine method-related experiences and acceptability of depot medroxyprogesterone acetate (DMPA) among women using this contraceptive for the first time.
Five hundred thirty-six women who received ...an injection of DMPA from any of seventeen clinical settings in southeast Texas, United States, were followed for 1 year. At each follow-up visit, patients were asked about their experiences with DMPA during the past 3 months and their plans to use this method in the future.
Amenorrhea, irregular bleeding, and weight gain were the conditions reported most frequently. Reports of amenorrhea, weight gain, and acne or skin problems increased over time, but complaints of longer periods decreased (
P <.001). Two pregnancies occurred during the study period. However, of these, one existed before the first injection. Depot medroxyprogesterone acetate's continuation rate at 1 year was 28.6%. Heavier and more frequent bleeding, increased cramping, amenorrhea, weight gain, headaches, depression, and nervousness were more frequent complaints of women who discontinued DMPA (
P <.05), whereas lighter and less frequent bleeding were reported more often by those who continued to use this method (
P <
Intolerable side effects and changes in menstrual pattern are the most frequently indicated reasons for discontinuing DMPA use. Our results suggest that DMPA's 1-year continuation rate may be lower than previously reported.
(Abstracted from N Engl J Med 2021;384:630–642)
Approximately 25% of women with uterine fibroids experience symptoms, most commonly heavy menstrual bleeding (HMB) or fibroid-associated pain. ...Long-acting gonadotropin-releasing hormone (GnRH) agonists are effective for the medical management of uterine fibroids, but their duration of use is limited by hypoestrogenic sequelae.
Background: Women who use sterilization for contraception are at risk for various sexually transmitted diseases, unless they use a barrier method. Use of condoms is significantly lower among ...sterilized women than among hormonal-contraceptive users. Among Hispanics, women's perception of risk and the influence of male partners are strong correlates of dual-method use. Limited data are available concerning use of condoms among sterilized women, in particular among Hispanics. Goals: Past and future use of condoms was examined and compared among 224 sterilized women and 104 hormonalcontraceptive users of Hispanic origin, and the reasons for use or nonuse of condoms were examined. Study Design: Cross-sectional survey. Results: As compared with hormonal-contraceptive users, sterilized women were significantly less likely to have used condoms in the 3 months before the study or to have plans to use them in the future (P < 0.001). Despite similarities between various HIV-related characteristics of sterilized and nonsterilized women, the former group had significantly lower perceptions of being at risk for both HIV and other sexually transmitted diseases. Sterilized women were also more likely to have used condoms for the purposes of dual protection from pregnancy. The strongest correlates of consistent condom use by both sterilized and nonsterilized Hispanic women were their perceived susceptibility to disease, male partners' positive opinion about condoms, and the women's ability to use condoms in long-term relationships. Furthermore, the practice of concealing the use of a contraceptive from a male partner was not uncommon, although this characteristic was not related to increased dual-method use. Conclusions: Sterilized women may be at a higher risk of disease than hormonal-contraceptive users. Among Hispanics, women's perception of risk and male partners' influences predict whether the women protect themselves from pregnancy and disease simultaneously.
Recently, observational studies have suggested an increased risk of nonfatal venous thromboembolic complications in women using oral contraceptives (OCs) containing the thirdgeneration progestins, ...gestodene and desogestrel. Because of the observational, rather than randomized, nature of these trials, the clinical relevance of these findings is difficult to interpret. Each study included one or more potential sources of bias. In particular, cases came almost exclusively from hospitalized patients with nonfatal venous thromboembo- lism, which represents only a minority of patients diagnosed with this condition according to current clinical practice. In the absence of a sound biologic rationale to explain the increased risk with third-generation OCs, and considering the potential sources of bias within the current studies, an alternative view argues against causality. Oral contraceptives remain safe and effective. Clearly, additional research is needed to determine the relationship between thromboembolic disease and the use of third-generation OCs. In the interim, women should be informed thoroughly with objective data on all risks associated with the use of OCs.
Background and Objectives: Women who are undergoing tubal sterilization are at risk for various sexually transmitted diseases (STDs) if they do not use a barrier method of contraception. There is a ...paucity of data concerning dual use of condoms among sterilized women. Goal: Planned use of condoms for protection against STDs was examined among 2,782 women undergoing surgical sterilization from 1991 to 1996. Study Design: Cross-sectional survey. Results: Planned condom use increased significantly over the 6-year study period. Of women who were using condoms before sterilization (n = 646), nearly half indicated no plans to do so after becoming sterilized. Thus, 11% of the total sample experienced an increased risk for exposure to human immunodeficiency virus or other STDs. Condom abandonment was significantly higher among Hispanic and married women. Multiple regression analysis was used to examine the association between condom use and various characteristics. Factors associated with future condom use were younger age, black ethnicity, being unmarried, previous STD, not having a steady partner, higher number of previous sexual partners, having used condoms for disease prevention in the past, and lack of partner involvement in the decision to undergo sterilization. Conclusions: Use of condoms among sterilized women appears to be on the rise, women at higher risk for disease are more likely than others to be using condoms, and only a small group of women experience an increased risk for exposure to disease as a result of selecting this permanent method of contraception.
The present study examined the perceptions, attitudes, and experiences of long-term contraceptive implant users. Group interviews were conducted to obtain qualitative in-depth attitude and opinion ...data from 31 women who had used the implant for a minimum of four years. Results indicated that many women had experienced side effects with implant use, in particular during the first year. The primary motivations for continuing the use of implant were: women's strong desire for a long-term, reversible, and convenient method that offered effective protection from pregnancy, a strong need for control over one's life, and general dissatisfaction with alternative methods. Exposure to negative media reports, and peer commentaries did not influence implant's continued use. However, intensive educational counseling prior to insertion played a significant role in the long-term use of implant. Findings from this study indicate that women are willing to accept side effects as the price to be paid for an effective and convenient contraceptive method, and for gaining control over their lives. Furthermore, women appear to be less influenced by opposing social climate, in the absence of negative personal experiences. Our findings underscore the importance of educational counseling prior to implant insertion.
OBJECTIVE:
To compare the 5-year cumulative probability of regret and risk factors for regret among women whose husbands underwent vasectomy with women after tubal sterilization.
METHODS:
A total of ...525 women whose husbands underwent vasectomy were compared with 3672 women who underwent tubal sterilization in a prospective, multicenter, cohort study.
RESULTS:
The cumulative probability of a woman expressing regret within 5 years after her husband’s vasectomy was 6.1% (95% confidence interval CI 3.6, 8.6), which was similar to the 5-year cumulative probability of regret among women after tubal sterilization (7.0%, 95% CI 5.8, 8.1). Women who reported substantial conflict with their husbands before vasectomy were more than 25 times more likely to request that their husband have a reversal than women who did not report such conflict (rate ratio 25.3, 95% CI 2.9, 217.2). Similarly, women who reported substantial conflict with their husbands or partners before tubal sterilization were more then three times as likely to regret their decision and more than five times as likely to request a reversal than women who did not report such conflict (rate ratio 3.1, 95% CI 1.4, 7.0, and rate ratio 5.4, 95% CI 1.6, 17.6, respectively).
CONCLUSION:
Most women did not express regret after their husband’s vasectomy and the probability of regret was similar to sterilized women. However, when there was substantial conflict between a woman and her husband before vasectomy or tubal sterilization, the probability of subsequent request for reversal was increased.
To determine cycle control, tolerability, and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg ethinyl estradiol (EE) to Ortho Tri-Cyclen LO ...(norgestimate 180/215/250 microg/EE 25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg).
A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who had taken a 30-35 microg EE-containing OC within 60 days of study start. The total number of cycles of exposure for the subset was 6,054 for Ortho Tri-Cyclen LO and 3,814 for Loestrin Fe 1/20. Additional analyses evaluated switchovers from Ortho Tri-Cyclen to Ortho Tri-Cyclen LO (N = 111).
Cycle control was assessed by daily diary cards reporting the frequency, severity, and duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) were considered to reflect tolerability. Satisfaction was evaluated by questionnaire.
The proportion of cycles in which subjects experienced breakthrough bleeding and/or spotting was significantly lower with Ortho Tri-Cyclen LO than Loestrin Fe 1/20. Discontinuations due to AEs and serious AEs were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6%, respectively) and Loestrin Fe 1/20 (3.2% and 0.7%, respectively). More women on Ortho Tri-Cyclen LO versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6, 89.3% of Ortho Tri-Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat satisfied, and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study conclusion. Conclusions-Switchovers from OCs containing 30-35 microg EE to Ortho Tri-Cyclen LO had excellent cycle control and tolerability, and were satisfied.
To evaluate pregnancy outcome in infertility patients with unrecognized exposure to a GnRH agonist in the first trimester.
Five women were given GnRH agonist before controlled ovarian ...hyperstimulation for in vitro fertilization cycles. The medication was administered in a dose of 0.5 mg/day, with drug exposure beginning on cycle day 21. The duration of exposure in all patients was 14-21 days. Thus, all five women received the medication at 3-6 weeks' estimated gestational age by menstrual dating. Pregnancy tests were not performed before the first injection of the GnRH agonist.
Three of the five pregnancies progressed to term without complication, and normal healthy infants were delivered. Missed abortion occurred in one pregnancy, and another ended in induced abortion at 13 weeks because of trisomy 18.
This experience suggests that despite manipulation of the hypothalamic-pituitary-ovarian axis by administration of GnRH agonist in the first trimester of pregnancy, normal pregnancies can result. Pregnancies in these patients should not be terminated because of drug exposure alone.
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