What is the Nonoxynol-9 Couples Study?
We conducted the Nonoxynol-9 study to determine the effects of Nonoxynol-9 (N-9) in
a cream referred to as Advantage 24 on the rectal mucosa of men who have sex
with men (MSM). The purpose of this study was to test the safety of Advantage
24 when used by MSM during anal intercourse. Safety was assessed for both
HIV-negative and HIV-postitive men.
We enrolled 35 male couples who:
- were both HIV-negative or both HIV-positive
- agreed to be monogamous throughout their participation in the study (up to 6-8
weeks)
- agreed to daily use of Advantage 24
- planned to have anal intercourse at least three times per week
- agreed to use non-N-9 condoms and no other N-9 products throught out the study
- agreed that one partner would always be receptive and the other insertive when
using Advantage 24
What were the findings?
Acceptability: Acceptability remains inconclusive and warrants
further study of redesigned applicators and ways to minimize rectal side effects.
Safety:
We found that low-dose N-9 was not significantly associated with rectal
ulcerations or toxicity to the penis when used by monogamous male couples
with the same HIV serostatus. Because other studies have found that N-9
causes significant damage to the lining of the rectum and the vagina, we
continue to NOT recommend the use of N-9. It is still available in many
lubricants and in lubricated condoms so please check the labeling.
How can I get more information on the results of this study?
If you have further questions about this or any of our research studies, feel
free to contact us. You can also click on the
links below to read the abstracts of the journal articles that were written
based on data gathered during the Nonoxynol-9 Couples Study:
- Acceptability of a bioadhesive nonoxynol-9 gel
delivered by an applicator as a rectal microbicide (1999)
- Safety and toxicity of nonoxynol-9 gel as a
rectal microbicide (1999)
We are no longer enrolling for this study, but if you are interested
in participating in HIV prevention research, please explore our research
page that lists studies that we are currently enrolling for.
Thank You
to all of our
Nonoxynol-9 Couples Study
Volunteers!
