FemCap with removal strap: ease of removal, safety and acceptability.

OBJECTIVES: FemCap is a silicone-rubber barrier contraceptive approved for marketing in the United States. To address reported problems with removal and dislodgment, the device's developer added a strap to the device and increased the height of the brim. This trial assessed whether the new design reduced removal difficulties and had any effects on dislodgment, genital pain/discomfort, safety, and acceptability. METHODS: Women used the strapped device for 8 weeks with follow-up visits at 2 and 8 weeks. Outcome measures were obtained through diary cards, questionnaires, and naked eye examination. Data from these 120 women were compared with data from 419 women who used the unstrapped FemCap in a previous contraceptive effectiveness study. RESULTS: The strapped device was not significantly easier for users to remove than the unstrapped device. Similar odds of dislodgment and cervical/vaginal irritation were seen with the two devices. Both female and male participants were significantly more likely to report pain/discomfort with use of the strapped device. Female users of the strapped device were significantly more likely to say they disliked their device. In six weeks, two pregnancies were observed, but pregnancy was not an endpoint in the study and no conclusions should be drawn regarding pregnancy rates. CONCLUSIONS: The modifications to the FemCap did not significantly improve the ease of device removal and appears to have resulted in significantly more female and male partner pain/discomfort and decreased acceptability, compared with the unstrapped device.

Single and multiple exposure tolerance study of polystyrene sulfonate gel: a phase I safety and colposcopy study.

OBJECTIVES: To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide. METHODS: Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days. RESULTS: All women completed the study except one in the Conceptrol group who experienced vaginal symptoms after her first use and was discontinued. After both the first use and after all uses, irritation was seen among more women in the Conceptrol group than in the PSS groups, reaching statistical significance with regard to any evidence of irritation, signs of irritation and product-related irritation. There were no adverse events that were serious, unexpected and related to product use in any group. The 5% concentration of PSS may be preferable in terms of leakage and acceptability. CONCLUSION: The results suggest that PSS has a safety profile comparable to that of the marketed nonoxynol-9 product, Conceptrol, and appears to be associated with less genital irritation.

Prospective randomized, controlled study of postoperative pain after titanium silicone rubber clip or Silastic ring tubal occlusion.

OBJECTIVE: To determine if laparoscopic sterilization using the Filshie clip causes less postoperative pain as compared to the Falope ring during the first 24 h after surgery. STUDY DESIGN: Forty subjects were enrolled. Five milliliters of 0.5% bupivicaine was injected at each of the two incision sites and 5 mL was dripped onto each fallopian tube. Subjects then received one Filshie clip and Falope ring on opposite fallopian tubes; the side of occlusion was randomized. Subjects were questioned about pain prior to the first administration of analgesics postoperatively, 1 and 2 h after surgery, at discharge, and 24 h after surgery. RESULTS: Forty subjects completed the study; 32 without major deviations from protocol. There was no significant difference in pain between sides with the Filshie clip or Falope ring at any times evaluated. CONCLUSION: There was no significant reduction in the postoperative pain associated with the Filshie clip as compared to the Falope ring within 24 h after surgery.

Mifepristone and misoprostol and methotrexate/misoprostol in clinical practice for abortion.

OBJECTIVE: The purpose of this study was to evaluate the efficacy, side-effect profile, and follow-up rates in women who obtain a medical abortion in a nonresearch setting. STUDY DESIGN: From December 1, 2000, to June 30, 2001, we prospectively followed 218 women who had been evaluated in our private office for medical abortion. Women received either mifepristone 200 mg orally followed 1 to 2 days later by self-administered misoprostol 800 microg vaginally or methotrexate 50 mg/m(2) intramuscularly followed 3 to 7 days later by self-administered misoprostol 800 microg vaginally. RESULTS: Of the 174 women who had a medical abortion, 148 women (85%) chose mifepristone/misoprostol, and 26 women (15%) chose methotrexate/misoprostol. In women up to 49 days of gestation, complete abortion occurred by the first follow-up visit in 82 of 86 women (95%; 95% CI, 89-99) and in 21 of 25 women (84%; 95% CI, 64-95) women, respectively. In women who used mifepristone/misoprostol from 50 to 63 days of gestation, complete abortions occurred in 56 of 59 women (95%; 95% CI, 86-99) women. Four women (2%; 95% CI, 1-6) were lost to follow-up. CONCLUSION: Medical abortion with mifepristone/misoprostol and with methotrexate/misoprostol can be provided in a nonresearch setting with efficacy similar to that reported in the medical literature for research protocols.

Predicting risk of ovulation in new start oral contraceptive users.

OBJECTIVE: To assess ovarian follicular development and ovulation rates in women starting to take oral contraceptives (OC) on menstrual cycle day 1, 4, or 7. METHODS: One hundred thirty women starting treatment with OC were randomized to begin use of ethinyl estradiol, 30 microg, plus norgestrel, 300 microg, on menstrual cycle day 1 (group 1), 4 (group 2), or 7 (group 3). Follicular development was assessed by vaginal ultrasonography on menstrual cycle days 7, 14, 21, and 28, and serum progesterone levels were measured on menstrual cycle days 21 and 28. At a.05 level of significance (two-tailed) and power of 80%, 84 participants were required to complete the study. Eighty-five women who met study criteria, made minimal dosing errors, and underwent at least three ultrasonographic examinations were analyzed. RESULTS: A follicle-like structure that reached a maximum diameter over 13 mm was observed in three of 29 (10.3%), five of 29 (17.2%), and 12 of 27 (44.4%) women in groups 1, 2 and 3, respectively (P = 0.003). The median maximum follicle size for each group was 9.0 mm, 9.0 mm, and 12.0 mm for start day 1, 4, and 7 respectively (P <.001). Evidence of ovulation based on serum progesterone was present in two, one, and zero women in groups 1, 2, and 3, respectively (P =.2). CONCLUSION: Although a delay in oral contraceptive initiation results in significantly more ovarian follicular development, the postponement does not appear to increase actual ovulation rates.