Expired Study
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Portland, Oregon 97239


Purpose:

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).


Study summary:

We 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.


Criteria:

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)


NCT ID:

NCT00612508


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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