A Randomized Controlled Safety and Acceptability Trial of Dextrin Sulphate Vaginal Microbicide Gel in Sexually Active Women in Uganda

dc.date.accessioned2021-04-15T14:23:25Z
dc.date.available2021-04-15T14:23:25Z
dc.date.issued2005-06-27
dc.description.abstractObjective: To assess the safety of dextrin sulphate (DS) gel compared to placebo gel in terms of local and systemic adverse events, and to determine the acceptability of dextrin sulphate gel. Design: A 4-week randomized trial of DS intra-vaginal gel, partially blinded, with placebo and observation control arms. Participants were randomized to use DS gel twice daily, placebo gel twice daily, DS gel pre-sex, or into an observation only arm. Methods: Sexually active women were recruited from post natal and HIV clinics at Nsambya Hospital, Kampala, Uganda. Screening, enrolment and follow-up visits took place every 1 or 2 weeks over an 8-week period and consisted of questionnaire interviews, colposcopy examinations, sexually transmitted infection screen and routine laboratory testing. Results: Out of a total of 172 women screened, 109 were randomized to use DS gel twice daily (65 women), placebo gel twice daily (15 women), DS gel pre-sex (nine women) or into an observation only arm (20 women). Two individuals had abnormal colposcopy findings in the DS twice daily gel use arm. Vaginal bleeding was reported as frequently by participants in the active gel arm as by participants in the placebo and observation only arms. No clinically significant difference was observed between arms in terms of vaginal flora, Candida, haemoglobin, white cell count, platelets, thrombin time, activated partial thromboplastin time, creatinine and aspartate aminotransferase results after 4 weeks of gel use. DS gel appeared to be acceptable to over 95% of the users. Conclusions: Results show a satisfactory safety and acceptability profile of dextrin sulphate gel.en_US
dc.identifier.citationBakobaki, J.M., Lacey, C.J., Bukenya, M.I., Nunn, A.J., McCormack, S., Byaruhanga, R.N., Okong, P., Namukwaya, S.W., Grosskurth, H. and Whitworth, J.A., 2005. A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda. Aids, 19(18), pp.2149-2156.en_US
dc.identifier.issn0269-9370
dc.identifier.urihttp://hdl.handle.net/20.500.12280/2652
dc.language.isoenen_US
dc.publisherLippincott Williams & Wilkinsen_US
dc.relation.ispartofseriesAids;19(18)
dc.subjectVaginal Microbicidesen_US
dc.subjectCondomsen_US
dc.subjectSafety Studiesen_US
dc.subjectAcceptability Studiesen_US
dc.subjectPrevention of Sexual Transmissionen_US
dc.subjectDextrin Sulphateen_US
dc.titleA Randomized Controlled Safety and Acceptability Trial of Dextrin Sulphate Vaginal Microbicide Gel in Sexually Active Women in Ugandaen_US
dc.typeArticleen_US

Files

Original bundle

Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
Byaruhanga_ARTICLE_2005_A_randomized.pdf
Size:
143.42 KB
Format:
Adobe Portable Document Format
Description:

License bundle

Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.71 KB
Format:
Item-specific license agreed upon to submission
Description: