Oregon Health and Science University
Portland, Oregon, 97239, United States
NCT Number: NCT00612508
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).
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Portland, Oregon, 97239, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
Other names: Desogen®
Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
Other names: NuvaRing®
Time frame: baseline, 84 days, 168 days
Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days
Time frame: over 168 days
Self-reported treatment-related and serious adverse events
Oregon Health and Science University
Other
The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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