Elsevier

Contraception

Volume 78, Issue 6, December 2008, Pages 465-473
Contraception

Original research article
Comparative crossover study of the PATH Woman's Condom and the FC Female Condom®

https://doi.org/10.1016/j.contraception.2008.07.020Get rights and content

Abstract

Background

Only one female condom [FC1 Female Condom (FC1)] is currently marketed, but it is poorly utilized, perhaps due to difficulty with insertion, discomfort and suboptimal functional performance during intercourse. The Program for Appropriate Technology in Health (PATH) Woman's Condom (WC) was developed in an effort to overcome these obstacles.

Study Design

This was a randomized crossover study to evaluate the functional performance, safety and acceptability of the FC1 and WC. Seventy-five couples were assigned to one of two condom use sequences (WC/FC1 or FC1/WC) at three centers. Four condoms of the first type were used by couples in four acts of intercourse at home over a 2–4-week period. After a follow-up visit, these procedures were repeated with the second assigned condom type. In a substudy of participants (n=25), a colposcopy was performed prior and subsequent to the first condom use of each of the two condom types. Condom performance was evaluated by calculating measures of function from questionnaires completed by the couple after each condom use. Safety was evaluated by reported urogenital symptoms with a given condom during or immediately following condom use and colposcopic signs of genital irritation in the substudy. Acceptability of each given condom type was measured by questionnaire.

Results

Total condom failure (slippage, breakage, etc., divided by the number of female condoms opened) was 31% for the WC and 42% for the FC1. Total clinical failure (slippage, breakage, etc., divided by the number of female condoms used) was 17% for the WC and 24% for the FC1. The proportion of condom failures was 10.9 percentage points less, and the proportion of clinical failure 6.7 percentage points less, when couples used the WC compared to the FC1 [90% CI: −18.5 to −3.3 and −12.6 to −0.8, respectively). Fewer women reported symptoms of urogenital irritation when using the WC vs. the FC1 either overall or when analyzing each use of the condom [woman as unit: −20 percentage points (90% CI: −30.5 to −9.3); condom use as unit: −12.3 percentage points (90% CI: −18.0 to −6.7)]. A similar result was seen for signs of urogenital irritation [woman as unit: −20 percentage points (90% CI: −42.7 to 4.8)]. Among participants with a preference, WC was preferred over the FC1 by twice as many males and by 2.6 times as many females.

Conclusions

While both female condoms were safe and acceptable in short-term use, the PATH Woman's Condom leads to less failure, was associated with fewer adverse events, and was more acceptable than the FC1 Female Condom.

Introduction

The Reality® Female Condom (currently called FC Female Condom®) (FC1; Female Health Company, Chicago, IL, USA) was approved by the US Food and Drug Administration (FDA) in 1993 as the first barrier contraceptive for women that offered limited protection against sexually transmitted infections (STIs). This female condom has a 6-month typical use pregnancy rate of 12.4 per 100 woman-years in a US population [1], has not been associated with trauma to the genital tract [2], prevents trichomoniasis recurrence [3], and may offer as much protection from STIs as male condoms [4]. The FC2 has been introduced as an updated version of this condom using synthetic latex for greater affordability [5].

Despite global need for a female controlled barrier device, there has been poor sustained utilization of this method and the potential impact of the device, as an HIV prevention strategy has not been fully evaluated. In female condom studies conducted over the past decade, varying proportions of users have liked the device and succeeded in using it, resulting in differing acceptability ratings in short-term acceptability studies, depending on the study population and the type of intervention [6], [7], [8], [9], [10]. These studies have identified a constellation of problems with female condom use including difficulty with insertion, discomfort and suboptimal functional performance during intercourse that may contribute to poor utilization.

The Program for Appropriate Technology in Health (PATH), a nonprofit, international health organization, has used an iterative user-driven development process to produce a novel female condom product in an attempt to overcome these obstacles. The PATH Woman's Condom (WC) has a thin, pliable plastic pouch that conforms to the shape of the vagina, is 9 in. long and has a flexible soft outer ring that is intended to protect the external genitalia (Fig. 1). The four oblong foam pieces on the outside of the pouch are intended to cling lightly to vaginal walls, ensuring stability of the device. The distal end of the pouch and foam pieces are packaged into a capsule which serves as an insertion aid and dissolves quickly when inserted into the vagina. The PATH Woman's Condom was easy to use and comfortable in a short-term acceptability study [11].

This study was designed to further test the functional performance, safety and acceptability of this novel female condom and to gain additional information for further development. This crossover study compared the PATH Woman's Condom (WC) to the FC1 after four uses of each condom type by 75 couples.

Section snippets

Materials and methods

Seventy-five couples were enrolled between December 2004 and August 2005 in this Phase I, comparative, open-label, two-period crossover study comparing the WC to the FC1 at three clinical centers: University of Pennsylvania Medical Center; University of Pittsburgh/Magee Womens Research Institute; and Advances in Health, Houston, TX, USA. The sample size was not selected on the basis of hypothesis testing. The crossover design was chosen because between-patient variation can be eliminated, and

Results

Of the 82 couples screened for eligibility, 75 were enrolled and 73 completed the study (Fig. 2). The functional performance definitions are detailed in Appendix A. Participant characteristics are described in Table 1. Participants at the Houston site differed from those at the other two sites in that they were likely to be older (female mean=34.3, male mean=35.5), identified themselves as Hispanic or black more frequently, and were less educated (female mean=13.2 years, male mean=12.6). They

Discussion

This was the first breakage and slippage study of the PATH Woman's Condom. The WC performed better than the FC1 with lower total clinical failure and total failure using female condom performance definitions adapted from male condom definitions of slippage and breakage [13]. There was significantly less failure with WC than with FC1 in regard to partially turning inside out and partial slippage and a trend toward significance with complete slippage. The statistical significance of these results

Acknowledgments

The authors thank Sarah Maitz for preparing the manuscript. Support for this study was provided by CONRAD through USAID. The opinions expressed herein do not necessarily reflect the opinions of USAID.

References (16)

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