Hormonal Contraception and Vaginal Health

Not Applicable

Completed

Interventions: Drug: Desogen (ethinyl estradiol and desogestrel)
Drug: NuvaRing (ethinyl estradiol and etonogestrel)

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.

Recruitment & Eligibility

Inclusion Criteria

Female
18-35 years
In general good health
With regular menses (every 28-32 days)
Seeking contraception and willing to use a hormonal method for at least 6 months

Exclusion Criteria

Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
History of recurrent vaginitis (> 2 episodes in one year, any type)
Pregnancy
Recent use of hormonal contraceptives
Depot medroxyprogesterone: 6 months
Progestin implants: 3 months
Oral contraceptives: 3 months
Hormone impregnated IUD: 3 months
Contraindications to use of oral contraceptive pills or vaginal ring
History of deep vein thrombosis
Known coagulopathy or thrombophilia
Unexplained vaginal bleeding
Uncontrolled hypertension
Diabetes with vascular changes
Present or history of hepatic disease or liver tumors
Migraines with neurologic changes
Myocardial infection
Pulmonary embolus
Stroke
Breast cancer
Hypersensitivity or allergy to hormonal contraception
Heavy Smoking ( ≥ 15 cigarettes per day)

Arm && Interventions

Group	Intervention	Description
Desogen	Desogen (ethinyl estradiol and desogestrel)	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
NuvaRing	NuvaRing (ethinyl estradiol and etonogestrel)	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

Primary Outcome Measures

Name	Time	Method
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.	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

Secondary Outcome Measures