Hormonal Contraception and Vaginal Health

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.

• Desogen (ethinyl estradiol and desogestrel) (Drug), also known as Desogen®: 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
• NuvaRing (ethinyl estradiol and etonogestrel) (Drug), also known as NuvaRing®: Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Primary outcomes

• 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 outcomes

• Adverse Events [over 168 days]: Self-reported treatment-related and serious adverse events

Sex: Female, ages: 18 Years to 35 Years, accepts healthy volunteers

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)

Participant flow

Outcome results

• Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. (Primary), Mean, mm: Desogen 0.01 +/- 0.06; NuvaRing -0.005 +/- 0.048
• Adverse Events (Secondary), Number, participants: Oral Contraceptive 1; Intravaginal Ring Contraceptive 0

Adverse events

Time frame: Every 6 months

Other adverse events by term

Limitations and caveats: Did not fully recruit; small number of subject

• Jeffrey T Jensen, MD., MPH, Principal investigator, Oregon Health and Science University