Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065858
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2003-08-01
Brief Title:
Effectiveness of BufferGel as a Vaginal Contraceptive
Sponsor:
Health Decisions
Organization:
Health Decisions
Study Overview
Official Title:
A Randomized Controlled Trial of the Efficacy Safety and Acceptability of BufferGel
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
BufferGel is a new contraceptive gel designed to be used with a diaphragm In addition to preventing pregnancy BufferGel may also prevent some types of sexually transmitted diseases STDs This study will compare BufferGel to Gynol II a currently available contraceptive gel
Detailed Description:
Vaginal acidity is thought to be one means by which the vagina prevents overgrowth or colonization by harmful microbial flora Sperm and many STD pathogens including HSV-1 and HSV-2 Neisseria gonorrhoeae Treponema pallidum Haemophilus ducreyi and a variety of bacterial vaginosis-associated bacteria are inactivated at pH less than 5 in vitro BufferGel a vaginal spermicide and microbicide is an acidic buffer that maintains the vagina at or near its natural state of mild acidity Formulated at vaginal pH pH 39 BufferGel prevents or limits the semen-induced rise in vaginal pH Carbopol 974P the buffering agent in BufferGel is a high molecular weight cross-linked polyacrylic acid used as a gelling or tableting agent in many pharmaceuticals it has a well-documented record of mucosal safety in animals and humans This study will determine the safety and contraceptive efficacy of BufferGel spermicide used with a diaphragm compared to Gynol II spermicide used with a diaphragm The study will also measure the frequency of bacterial vaginosis urinary tract infections and cervical lesions in women using BufferGel compared with Gynol II
Participants in this study will be fitted for a diaphragm and randomized to receive either BufferGel or Gynol II All participants will be instructed on the use of the test product with the diaphragm Participants will be followed through 6 menstrual cycles approximately 7 months and will have 4 study visits and one study phone call Some participants may enroll in an extended version of the study and be followed for an additional 6 cycles and 2 additional study visits Study visits will include a gynecologic exam Pap smear and blood and urine tests Participants will be asked to keep a diary to record information on product use Some participants may also be asked to enroll in a colposcopy substudy These participants will undergo colposcopy at study entry and after cycles 1 3 and 6
Participants in this study will be fitted for a diaphragm and randomized to receive either BufferGel or Gynol II All participants will be instructed on the use of the test product with the diaphragm Participants will be followed through 6 menstrual cycles approximately 7 months and will have 4 study visits and one study phone call Some participants may enroll in an extended version of the study and be followed for an additional 6 cycles and 2 additional study visits Study visits will include a gynecologic exam Pap smear and blood and urine tests Participants will be asked to keep a diary to record information on product use Some participants may also be asked to enroll in a colposcopy substudy These participants will undergo colposcopy at study entry and after cycles 1 3 and 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None