NCT00612508

Hormonal Contraception and Vaginal Health

The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraceptive Usage
• Vaginal Epithelial Disruption

Interventions

Type	Name	Description
DRUG	Desogen (ethinyl estradiol and desogestrel)	1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
DRUG	NuvaRing (ethinyl estradiol and etonogestrel)	Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-02-11
• Last updated: 2012-11-08
• Results posted: 2012-11-08

Locations

1 site across 1 country: United States