Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 11:48 AM
Study NCT ID:
NCT00612508
Status:
COMPLETED
Last Update Posted:
2012-11-08
First Post:
2008-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hormonal Contraception and Vaginal Health
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
Detailed Description:
The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.
Study Oversight
Has Oversight DMC:
False
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?: