The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
Overview
- Phase
- Not Applicable
- Intervention
- Desogen (ethinyl estradiol and desogestrel)
- Conditions
- Contraceptive Usage
- Sponsor
- Oregon Health and Science University
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Jeffrey Jensen
MD MPH
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Desogen
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
Intervention: Desogen (ethinyl estradiol and desogestrel)
NuvaRing
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
Intervention: NuvaRing (ethinyl estradiol and etonogestrel)
Outcomes
Primary Outcomes
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
Time Frame: 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)