A comparative study of the safety and efficacy of femcap®, a new vaginal barrier contraceptive, and the ortho all-flex® diaphragm

Mauck, Christine; Callahan, Marianne M.; Weiner, Donald A.; Dominik, Rosalie

doi:10.1016/s0010-7824(99)00068-2

Cited by 52 publications

(40 citation statements)

References 6 publications

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“…Among these new devices are the FemCap™ cervical cap and SILCS ® diaphragm, both made of medical-grade silicone, which is less allergenic, more durable, and more tolerant of heat, light and petroleum products than the latex diaphragm. In the USA, contraceptive trials have been conducted or are ongoing for these new devices, [22][23][24][25] and acceptability studies have been conducted internationally, primarily in adult women or women in stable monogamous relationship, for the diaphragm 14,15,[26][27][28][29] and for SILCS. 30,31 Although product acceptance has been high in these studies, findings cannot be extrapolated to younger, or unmarried, women whose choices and acceptability differ for other contraceptive and disease prevention methods.…”

mentioning

confidence: 99%

Feasibility and potential acceptability of three cervical barriers among vulnerable young women in Zimbabwe

Straten

Sahin-Hodoglugil²,

Clouse³

et al. 2010

j fam plann reprod health care

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Background We explored the potential acceptability of three cervical barriers (CB) (Ortho All-Flex ® diaphragm, SILCS ® diaphragm, FemCap TM cervical cap) among sexually experienced Zimbabwean young women.Methods Forty-five young women (aged 16-21 years) received an individual CB educational session. Participants were then randomly assigned to one of the three CBs in a 1:1:1 ratio, and practised insertion and removal of their device at the clinic. Next, participants were interviewed on their practice experiences, and their post-practice attitudes towards CB.Results All 45 young women were willing and able to insert their assigned device. The majority reported "easy" insertion and removal and 93% "liked" the device they tried. All showed interest in participating in future CB studies: when asked which device they would like to try 13 IntroductionYoung women are the most vulnerable population for heterosexual acquisition of HIV. 1 Adolescents are more susceptible than adult women, likely because an immature genital tract increases their susceptibility to physical trauma and sexually transmitted infections (STIs). 2 Furthermore, gender inequalities in sexual relationships often leave young women unable to negotiate condom use. [3][4][5] In Zimbabwe, 25% of females aged 15-24 years are infected with HIV compared to 11% of males in that age group. 6 Additionally, with 40% of Zimbabwean women aged 15-49 years being non-current users of modern family planning methods, there remains a significant unmet need for contraception, particularly among young sexually active women (63% non-current users among 15-19-yearolds), as indicated by estimates that up to 60 000-80 000 illegal and unsafe abortions occur each year. 6,7 Male condoms are the only currently available method known to provide dual protection by preventing pregnancy in the future, over half (58%) chose SILCS, regardless of the device they had tried. The majority felt comfortable touching their genitals to insert/remove the CB and most participants favoured methods' attributes associated with female-control and non-interference with sex. Over half the participants said they would prefer to use a CB continuously compared to episodic use. Two-thirds of them expressed interest in CB for dual protection. ConclusionThe concept of CB, and initial insertion experience, were well accepted in this selected, small group of Zimbabwean young women. Evaluating CB in larger studies seems feasible in this population. and STIs including HIV; although not proven in clinical trials, female condoms are believed to provide similar protection. 8,9 While female condoms are woman-initiated, they still require male partner co-operation, as they are noticeable during sex. Cervical barriers (CB), including the diaphragm, are also woman-initiated methods, and act by protecting the cervix from exposure to ejaculate. The diaphragm is one of the oldest contraceptives, although it has lost much of its popularity with the advent of hormonal contraceptives. 10 CB might be of interest to...

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mentioning

confidence: 99%

Feasibility and potential acceptability of three cervical barriers among vulnerable young women in Zimbabwe

Straten

Sahin-Hodoglugil²,

Clouse³

et al. 2010

j fam plann reprod health care

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“…The objectives were tested by comparing the data from couples using the strapped device to data from the first 8 weeks of follow-up among couples using the unstrapped device in the contraceptive effectiveness study [1]. In the current study, female participants had follow-up visits 2 and 8 weeks after enrollment, whereas for the contraceptive effectiveness study [1], female participants were seen 2, 6, 12 and 28 weeks after enrollment.…”

Section: Discussionmentioning

confidence: 99%

“…Women were enrolled at the General Clinical Research Center at Magee-Women's Hospital in Pittsburgh, PA, and CONRAD's Clinical Research Center at the Eastern Virginia Medical School in Norfolk, VA. Both sites were among the 10 centers that had participated in the Phase II/III contraceptive effectiveness study [1]. The current study was approved by the institutional review board for each site.…”

Section: Methodsmentioning

confidence: 99%

“…A Phase II/III contraceptive effectiveness trial comparing FemCap with the All-Flex ® diaphragm (Ortho-McNeil Pharmaceutical, Raritan, NJ) showed that, according to the criterion set by the study, the FemCap was inferior to the diaphragm in contraceptive efficacy, although both had associated pregnancy rates that were within the expected range for barrier methods [1]. However, significantly, more FemCap users than diaphragm users reported difficulty with removal and occurrences of dislodgment (meaning the device partially or completely coming out on its own).…”

Section: Introductionmentioning

confidence: 99%

“…Data from this study were compared with data from the FemCap arm of the contraceptive effectiveness study of the original device design [1]. The primary objective was to determine whether the new design reduced removal difficulties observed with the unstrapped device.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2006

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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.

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