This paper is only available as a PDF. To read, Please Download here.
Abstract
The objectives of this study were to determine the amount of nonoxynol-9 (N-9) remaining
in the vagina 30 min and 1, 1.5, 2, and 4 h after vaginal insertion of a single sheet
of VCF® containing 70 mg N-9 and to compare these results to the manufacturer's instructions
for use of this product. A new method of vaginal lavage was used to obtain samples
for N-9 determination.
This was an open-label, noncomparative, pharmacokinetic study in 12 healthy women
volunteers not at risk for pregnancy.
The study consisted of a screening visit followed by five test visits approximately
1 month apart and a final visit 1 week after all test visits were completed. At each
test visit, the investigator inserted a single sheet of VCF in the vagina of the volunteer
at midcycle. The volunteer remained in the clinic and underwent vaginal lavage with
normal saline after one of five specified time intervals had elapsed. The sequence
of the intervals completed by each volunteer was determined by randomization. When
undissolved film was found in the vagina, it was removed prior to lavage and assayed
for N-9 content separately from that recovered in lavage fluid. It was assumed that
the N-9 in undissolved film would not contribute significantly to sperm immobilization.
Between 18.5 and 28.5 mg of N-9 were recovered in lavage fluid after intervals of
0.5, 1, 1.5, and 2 h. These levels did not differ statistically (p > 0.05). The amount
of N-9 recovered dropped significantly at 4 h to 11.0 mg.
If it is assumed that an N-9 concentration of 0.100 mg/mL is required to immobilize
sperm in vitro, this study suggests that the amount of N-9 remaining in the vagina
in the form of dissolved film up to 4 h after insertion of VCF is sufficient to immobilize
sperm. The lavage procedure may not have recovered all N-9 remaining in the vagina.
However, intercourse did not take place between insertion and lavage; if it had, the
proportion of the film remaining undissolved and the total amount N-9 remaining in
the vagina at the time of examination might have been affected.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to ContraceptionAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Vaginal spermicides: some current concerns.Br J Fam Plann. 1992; 17: 118-119
- New issues in spermicide use.Contemp Ob/Gyn. 1994; 39: 29-39
- Population reports: barrier methods.in: 1984: 12
- Inactivation ofLancet. 1985; 2: 1422-1423
![Math Eq]()
cultures of normal human lymphocytes by nonoxynol-9 in vitro. - Nonoxynol-9 and HTLV-III (letter).Lancet. 1986; 1: 1153
- Spermicides for controlling the spread of HIV.AIDS. 1992; 6: 341-342
- Condoms, spermicides, and the transmission of human immunodeficiency virus: a review of the literature.Am J Public Health. 1988; 78: 521-524
- Studies on the development of a vaginal preparation providing both prophylaxis against venereal disease and other genital infections and contraception: II. Effect in vitro of vaginal contraceptive and non-contraceptive preparations on Treponema pallidum and Neisseria gonorrhoea.Br J Vener Dis. 1972; 48: 57-64
- An animal model for sexual transmission of HIV.in: Alexander NJ Gabelnick HL Spieler JM Heterosexual Transmission of AIDS. Wiley-Liss, New York1990: 123-136
- Inactivation of herpes simplex viruses by nonionic surfactants.Antimic Agents Chemother. 1978; 13: 6867-6890
- Demonstration of spirocheticidal effect of chemical contraceptives on Treponema pallidum.Pan Am Health Organ Bull. 1982; 16: 59-64
- Spermicides and sexually transmitted diseases: new perspective.North Carolina Med J. 1986; 47: 569-572
- Family planning, sexually transmitted diseases and contraceptive choice: a literature update—Part I.Fam Plann Persp. 1992; 24: 75-84
- Commentary: methods women can use that may prevent sexually transmitted disease, including HIV.Am J Public Health. 1992; 82: 1473-1478
- A case control study of spermicides and gonorrhaea.JAMA. 1984; 251: 2822-2824
- Personal protection against sexually transmitted diseases.Am J Obstet Gynecol. 1986; 155: 180-188
- Effect of the contraceptive sponge on chlamydial infection, gonorrhea and candidiasis: a comparative clinical trial.JAMA. 1987; 257: 2308-2312
- Vaginal contraceptives. effective protection from sexually transmitted diseases for women?.J Repro Med. 1988; 33: 307-311
- Use of nonoxynol-9 and reduction in rate of gonococcal and chlamydial cervical infections.Lancet. 1992; 339: 1371-1375
- Sexual practices in the transmission of hepatitis B virus and prevalence of hepatitis delta virus infection in female prostitutes in the United States.JAMA. 1992; 267: 2477-2481
- Efficacy of spermicide use and condom use by HIV-discordant couples in Zambia.in: Eighth International Conference on AIDS, Amsterdam, NetherlandsJuly 19–24, 1992
- Barrier contraceptive use and HIV infection among high-risk women in Cameroon.AIDS. 1993; 7: 725-731
- Efficacy of nonoxynol 9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes.JAMa. 1992; 268: 477-482
- A dosing study of nonoxynol-9 and genital irritation.Int J STD AIDS. 1993; 4: 165-170
- The effects of trequent nonoxynol-9 use on the vaginal and cervical mucosa.Sex Transm Dis. 1991; 18: 176-179
- Preclinical evalnation of new vaginal contraceptives.in: Zatuchni GI Sobrero AJ Speidel JJ Vaginal Contraception. Harper & Row, New York1979: 234-246
- Spermicidal agents: effectiveness, use, and testing.in: Zatuchni GI Sobrero AJ Speidel JJ Vaginal Contraception. Harper & Row, New York1979: 48-65
- Longevity of Ortho Creme and Gynol II in the contraceptive diaphragm.Contraception. 1986; 34: 381-393
- A review of spermicidal products.Br J Fam Plann. 1988; 14: 9-15
Package insert, Vaginal Contraceptive Film. Apothecus Inc. Oyster Bay, NY.
- Table 27-3, Summary of studies of contraceptive failure.in: Contraceptive Technology. 16th revised edition. Irvington Publishers, New York1994: 655-659
- Chemical vaginal contraceptives: preclinical evaluation.in: Mauck CK Cordero M Gabelnick HL Barrier Contraceptives, Current Status and Future Prospects. Wiley-Liss, New York1994: 147-162
- The function of the cervix in fertility.Fertil Steril. 1972; 23: 295-306
- Vaginal anatomy and physiology as they relate to sexual intercourse.in: Mauck CK Cordero M Gabelnick HL Barrier Contraceptives, Current Status and Future Prospects. Wiley-Liss, New York1994: 77-89
- Abnormal uterine bleeding.in: Jones HW Wentz AC Burnett LS Novak's Textbook of Gynecology. Williams & Wilkins, Baltimore1988: 3792
cultures of normal human lymphocytes by nonoxynol-9 in vitro.Article info
Publication history
Accepted:
June 2,
1997
Received in revised form:
May 23,
1997
Received:
April 22,
1997
Identification
Copyright
© 1997 Published by Elsevier Inc.
