Hormonal Contraception and Vaginal Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraceptive Usage, Vaginal Epithelial Disruption

Intervention / Treatment
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* Drug: Desogen (ethinyl estradiol and desogestrel)
* Drug: NuvaRing (ethinyl estradiol and etonogestrel)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desogen<br>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 | Drug: Desogen (ethinyl estradiol and desogestrel)<br>* 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol<br>* Other names: Desogen®;|
| Active Comparator: NuvaRing<br>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 | Drug: NuvaRing (ethinyl estradiol and etonogestrel)<br>* Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring<br>* Other names: NuvaRing®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. | 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 | baseline, 84 days, 168 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Self-reported treatment-related and serious adverse events | over 168 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraception, NuvaRing, Desogen, vaginal biopsy