Contraceptive Usage, Vaginal Epithelial Disruption
Conditions
Keywords
contraception, NuvaRing, Desogen, vaginal biopsy
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.
Interventions
DRUGDesogen (ethinyl estradiol and desogestrel)
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
DRUGNuvaRing (ethinyl estradiol and etonogestrel)
Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
Sponsors
Oregon Clinical and Translational Research Institute
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | over 168 days | Self-reported treatment-related and serious adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desogen oral contraceptive | 7 |
| NuvaRing intravaginal contraception | 7 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | NuvaRing | Desogen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age Continuous | 24 years STANDARD_DEVIATION 3.4 | 28 years STANDARD_DEVIATION 4 | 25.8 years STANDARD_DEVIATION 4.1 |
| Region of Enrollment United States | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
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
Population: A total of 14 subjects (7 R, 7 P) were randomized and had an initial biopsy; 11 (6 R, 5 P) returned for a biopsy at 3rd cycle (84 days), and 6 (3 R, 4 P) 6th cycle (168 days).~The analysis used a paired T test comparing the baseline mean to the mean as the end of the 3rd cylce (e.g. 84 days) and the 6th cycle (168 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desogen | Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. | mean difference at 84 days | 0.01 mm | Standard Deviation 0.06 |
| Desogen | Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. | mean difference at 168 days | -0.02 mm | Standard Deviation 0.09 |
| NuvaRing | Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. | mean difference at 84 days | -0.005 mm | Standard Deviation 0.048 |
| NuvaRing | Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. | mean difference at 168 days | .007 mm | Standard Deviation 0.028 |
Secondary
Adverse Events
Self-reported treatment-related and serious adverse events
Time frame: over 168 days
Population: All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desogen | Adverse Events | 1 participants |
| NuvaRing | Adverse Events | 0 participants |