J Int Med Res (\975) 3, 292
`
`Clinical Evaluation of C-Film, a Vaginal Contraceptive
`
`o Frankman, M D, Ν Raabe, MD and C A Ingemansson, M D,
`Gynaecology,
`Karolinska Hospital, Stockholm
`and Department
`Esk list una Hospital, Eskilstuna,
`Sweden
`
`
`
`
` Department of Obstetrics and
`
`of Obstetrics
`and
`
`Gynaecology,
`
`in tlie form of a
`C-Film is a novel presentation of a vaginal contraceptive
`nonylphenoxy-
`square, water-soluble, plastic film containing
`tlie spermicide,
`polyetlioxyeihanol.
`The film was used as the sole contraceptive method by
`237 women over a total period of 1,866 months. Fourteen
`pregnancies
`occurred,
`tlius giving a pregnancy
`rate of nine per hundred
`woman-years.
`Most of these resulted from a failure to follow
`instructions:
`the true method
`failure being two per hundred woman-years. Life-table analysis of the results
`in 156 women observed for more than twelve months gives a pregnancy
`rate
`of 6-5",, and a continuation rate o/ 6 8 · 6 " „. The low continuation rate was
`largely a reflection of the women's distrust of the method. The
`study,
`however,
`indicates
`that C-Film
`is a good vaginal contraceptive, which is
`well tolerated and acceptably
`reliable
`though it should not be
`considered
`as an alternative
`to oral contraception or to an intra-uterine
`contraceptive
`device.
`
`Introduction
`Much more attention has bee n paid in the
`last decade to medical methods o f contracep­
`tion (oral contraceptives and the intra-uterine
`contraceptive device)
`than
`to
`the older,
`non-medical methods
`like
`the diaphragm,
`condom and spermicidal agent. Yet
`there
`have been useful developments in chemical
`contraception, not only as regards the type
`of spermicidal agents but also in the method
`of presentation.
`Three basic forms of chemical contracep­
`tion have been available for many years:
`suppositories, creams, jellies and pastes, all
`of which are squeezed out of a tube, and
`foams, either as a tablet o r a pressurised
`aerosol. To these must now be added a water-
`soluble film, invented by Hotay and introdu­
`ced
`into contraceptive practice by Csoma
`et al (1969). Hotay called
`this C-Film. It
`consists of a 5 X 5 cm piece of water-soluble
`plastic (polyvinyl alcohol) film, which serves
`
`as the base for the spermicidal agent. The
`film
`is folded once, placed over
`the dry
`finger and inserted high into the vagina, or
`it may be folded over the tip of the erect
`penis just before intromission. More recently,
`the male method has been considered to be
`less reliable than digital
`insertion
`into
`the
`vagina (Pariser, 1974) After
`insertion,
`the
`film dissolves rapidly in the normal vaginal
`secretion to provide a spermicidal barrier i n
`the region of the cervix.
`In its original presentation, C-Film con­
`tained
`the spermicidal agent, cetylpyridine
`bromide. This has now been replaced by the
`surface active, non-ioni c compound, non-
`oxynol-9
`(nonylphenoxypolyelhoxyethanol).
`Non-ionic compounds are generally regarded
`as highly efiective
`spermicides, probably
`superior to thos e previously in use. In its
`present, form C-Film has passed the IPPF
`Agreed Test for Total Spermicidal Power
`(IPPF, 1965).
`
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`Exhibit 1008
`Page 001
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`

`

`o Frankman and C A
`
`Ingemansson
`
`293
`
`The new presentation of C-Film was as­
`sessed
`for
`its
`tolerance, acceptability and
`efficiency
`in preventing pregnancy at
`three
`family planning clinics in Sweden: the W HO
`Clinical Research Centre. Karolinska Hos­
`pital, Stockholm; Mentalvardsbyran, Stock­
`holm; and the Department of Obstetrics and
`Gynaecology, Eskilstuna Hospital, Eskilstuna.
`
`M a t e r i a ls a od M e t h o ds
`Presentation. C-Film was made available by
`the manufacturers
`in a package containing
`ten semi-transparent films, placed between
`silver foil interleaving (Figure 1).
`
`carefully
`patient was
`Each
`instructions.
`to insert one film high into
`the
`instructed
`vagina at least five minutes before coitus.
`Another film was to be inserted
`if coitus
`took place later than an hour after insertion.
`The same instruction applied to repeated acts
`of coitus. In the early part of the study the
`male method of introduction was recommend­
`ed as an alternative but this was abandoned
`
`following reports of an increased failure rate
`from other centres.
`
`to women
`Patients. C-Film was offered
`attending a contraceptive clinic as a method
`which should prove as reliable as vaginal
`foam or barrier methods. The clinic doctors
`emphasized that the film would not provide
`the same degree of reliability as oral contra­
`ception or the intra-uterine device, but no
`attempt was made
`to
`limit acceptors
`to
`highly-motivated women who could be expec­
`ted to use the method reliably. Women using
`other contraceptive methods were excluded
`from the study, as were those who stated a
`frequency of coitus of less than once a week.
`Originally,
`265 women
`accepted
`the
`method. Twenty-eight of them were subse­
`quently excluded from
`the study,
`fourteen
`because they never used the method, twelve
`because they used it as an adjunct to other
`methods and two because they were impos­
`sible to trace either by telephone or letter.
`The
`remaining 237 women
`have
`been
`
`Fig 1 Packaging of C-Film
`
`Downloaded from
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`Par Pharm., Inc., et al.
`Exhibit 1008
`Page 002
`
`

`

`294
`
`The Journal of International Medical Research
`
`tj. .1,1
`1μ1 ·ι
`·
`
`
`
`[1 m [1
`
`^^^^
`
`mm.
`
`w////////A
`
`Age and parity o) siihjccts entering
`
`trial (L'lfc-tahle
`
`group)
`
`observed for periods varying from five
`twenty-three months.
`
`to
`
`Table I
`
`Results
`The 237 women used C-Film for a total of
`1,866 months. During
`this
`time
`fourteen
`pregnancies occurcd, which gives a use-
`effectiveness failure rate of nine per hundred
`woman-years. However, as can be seen from
`Table 1, eleven of the women failed to use
`the method as
`instructed. Thus
`the
`true
`method failure rate (theoretical effectiveness)
`is about two per hundred woman-years.
`Of the total number of women, 156 have
`been observed for twelve months or longer.
`This permits an analysis of the data accord­
`ing to the
`life-table method (Tietze 1967)
`The overall pregnancy rate was 6-5";, and
`the continuation rate 68·6"„. The reasons
`for stopping using C-Film are listed in Table
`2. About half of those who stopped using
`the method did so for "irrelevant" reasons,
`i.e.
`reasons not directly
`related
`to
`the
`acceptability or the efficiency of the method.
`Among the "relevant" factors for stopping,
`apart
`from pregnancy, were difficulty
`in
`applying the film properly and minor com­
`plaints about the sharp edges of some of the
`
`Factors predisposing to pregnancy among 237 women
`using C-Film
`
`Reason
`
`lor
`
`pregnancy
`
`Number of
`cases
`
`Film not always used
`No reason disclosed
`Film used by male
`Coitus within live minutes of
`introduction of C-film
`Repeated coitus, no additional
`him used
`
`7
`3
`Ί
`
`1
`
`1
`
`Total
`
`14
`
`films. This seemed to happen after a package
`had been opened for a few weeks and could
`be attributed to air coming in contact with
`the
`individual
`films. Patients
`sometimes
`complained of difficulty in finding a film in
`a nearly empty package. A
`few patients
`inserted
`the
`interleaved silver foil as well
`as the him, a problem that highlights the need
`for careful instruction in usage. Most of them,
`however, found the film acceptable and easy
`to in.sert; problems like vaginal irritation or
`
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`Par Pharm., Inc., et al.
`Exhibit 1008
`Page 003
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`

`o Frankman and C A
`
`Ingemansson
`
`Table 2
`
`Reasons for stopping C-Film among 156 women using it for twelve months or longer
`
`295
`
`' • Relevant" factors
`
`Pregnancies
`Difficulty in using
`Side etfects
`Suspected pregnancy
`(later shown to be delayed period)
`
`Total
`
`Number of
`cases
`
`"Non-relevant" factors
`
`Number of
`cases
`
`10
`9
`5
`
`1
`
`25
`
`Did not trust Him
`Wished to fall pregnant
`Leaving clinic area
`No further need for contraception
`No stated reason
`
`Total
`
`9
`6
`6
`-)
`1
`
`24
`
`complaints of a " r u n n y" vaginal loss were
`encountered only rarely.
`
`Discussion
`The 237 women in this study did not constitute
`a particularly well-motivated group, who
`could be relied upon
`to use a chemical
`contraceptive
`according
`to
`instructions.
`Indeed, many of them had tried several other
`methods of contraception and found none
`that was acceptable or reliable. This
`fact
`alone could explain
`the
`low continuation
`rate as well as the relatively high failure in
`use-effectiveness. True method
`failure, on
`the other hand, was uncommon.
`The results are clearly far better than those
`reported by Smith et al (1974) in a much
`smaller study. They recorded nine pregnancies
`among forty-five women during 175 cycles, a
`failure
`rate
`in use-effectiveness of 62 per
`hundred woman-years. This is about the same
`as would be expected among women using
`no contraceptives
`at
`all. Unfortunately,
`these workers
`failed
`to distinguish
`fully
`between method and patient failure. Some
`authors (Swyer 1968, Peel & Potts 1969)
`argue that all failures should be regarded as
`method failures, since intermittent use of a
`method
`implies dissatisfaction with it. We
`accept this view only in part, for it seems lo
`us important to know how well a method
`works when properly used. Knowing
`the
`true method failure as well as the overall
`failure rate allows the individual prescriber to
`make a much better judgement about
`the
`results to be expected in routine contraceptive
`usage.
`
`In our experience, C-Film offers good
`contraception for
`the reliable user, always
`provided she receives proper instruction. She
`should be warned to change the method if
`she finds it difficult to follow instructions, if
`she is familiar with her anatomy and can
`place the film high in the vagina in the region
`of the cervix, the reliability of the method is
`likely to be excellent. Nathan et al (1974)
`have shown that active spermicidal material
`penetrates far into the cervical canal only
`two minutes after high vaginal application of
`the film. Even among our group of women
`with less than perfect motivation, the results
`were comparable, if not superior, to those
`reported with other chemical or barrier
`methods (Marshall 1969). The low incidence
`of relevant side-effects confirms the
`findings
`of other studies on C-Film (Lichtman et al
`1973).
`
`Despite our generally satisfactory experi­
`ence, C-Film should not be offered as an
`alternative
`to oral contraception or
`the
`intra-uterine device. However, it will almost
`certainly increase the reliability of the device,
`as well as that of the condom. It may also
`be used alone in certain circumstances—to
`postpone pregnancy for a few months, in
`women approaching
`the menopause
`and
`where absolute protection against pregnancy
`is not required.
`C-Film is certainly more convenient lo use,
`as well as more aesthetic, than foams, dia­
`phragms or condoms, and offers a good
`alternative to any of them, lis introduction
`into family planning clinics should be wel­
`comed, for
`the more varied
`the methods
`
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`Par Pharm., Inc., et al.
`Exhibit 1008
`Page 004
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`

`296
`
`The Journal of International Medical Research
`
`the chances of
`the better are
`available,
`finding
`the most acceptable method for the
`individual.
`
`REFERENCES
`Lichtman, A S, Davajan V & Tucker D
`(1973) C-film, a new vaginal contraceptive. Contracep­
`tion 8, 291
`Marshall J
`Barrier Methods of Contraception. IPPF European
`and Near East Region Conference, Budapest
`Nathan Ε
`In vitro og in vivo undersogelser af C-Film, et nyt
`contraceptivum, (To be published)
`Pariser G
`(1974) Personal communication
`
`Peel J & Potts D Μ
`(1969) Textbook of Contraceptive Practice, Cambridge
`University Press, Cambridge.
`Smith Μ et al
`(1974) C-film as a contraceptive. British Medical
`Journal, Iv, 291
`Swyer G I Μ
`(1968) Collection and evaluation of data on contracep­
`tion. International Journal of Fertility, 13, 366
`Tietze, C
`(1967)
`Intrauterine contraception. Recommended
`for data analysis. Studies
`in Family
`procedures
`Planning, Suppl. 18
`Csoma B, Görgey Μ, Papp Ζ, Gardo S, Herpay G &
`Dolhay Β
`(1969) Új fogamzásgátló módszer Arvosi Helilap 110,
`1074
`IPPF
`total spermicidal power.
`for
`test
`(1965) Agreed
`IPPF Handbook, 2nd Edition, p. 74.
`
`Downloaded from
`
`
`
` by guest on October 7, 2016imr.sagepub.com
`
`Par Pharm., Inc., et al.
`Exhibit 1008
`Page 005
`
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