Conditions: Contraceptive Usage Vaginal Epithelial Disruption
Keywords: contraception NuvaRing Desogen vaginal biopsy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: yes

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.

Arms:
arm 1: Drug: ethinyl estradiol and desogestrel

1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.

Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles arm 2: Intravaginal Contraception

ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles

Interventions: intervention 1: Desogen (ethinyl estradiol and desogestrel) intervention 2: NuvaRing (ethinyl estradiol and etonogestrel)
Intervention descriptions: intervention 1: 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol intervention 2: Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Protocol document: