Hormonal Contraception and Vaginal Health

Oregon Health and Science University14 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Contraceptive Usage Vaginal Epithelial Disruption

Interventions

Desogen (ethinyl estradiol and desogestrel)DRUG

1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol

NuvaRing (ethinyl estradiol and etonogestrel)DRUG

Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Time frame: baseline, 84 days, 168 days

Secondary Outcomes

Adverse Events

Self-reported treatment-related and serious adverse events

Time frame: over 168 days

Data from ClinicalTrials.gov

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