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| Name | Class |
|---|---|
| Oregon Clinical and Translational Research Institute | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desogen | Active Comparator | 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 |
|
| NuvaRing | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desogen (ethinyl estradiol and desogestrel) | Drug | 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Self-reported treatment-related and serious adverse events | over 168 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey T Jensen, MD., MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
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| Label | URL |
|---|---|
| (Women's Health Research Unit website) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desogen | oral contraceptive |
| FG001 | NuvaRing | intravaginal contraception |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desogen | oral contraceptive |
| BG001 | NuvaRing | intravaginal contraception |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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) | Posted | Mean | Standard Deviation | mm | baseline, 84 days, 168 days |
|
Every 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desogen | oral contraceptive |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding from vagina | Reproductive system and breast disorders | SNOMED-CT 289530006 | Non-systematic Assessment | Minor bleeding and pain associated with biopsy |
Did not fully recruit; small number of subject
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oregon Health & Science University | Women's Health Research Unit | 503-494-3666 | whru@ohsu.edu |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017135 | Desogestrel |
| D004997 | Ethinyl Estradiol |
| C516519 | NuvaRing |
| C044815 | etonogestrel |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 |
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| NuvaRing (ethinyl estradiol and etonogestrel) | Drug | Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring |
|
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | NuvaRing | intravaginal contraception = R (ring) |
|
|
| Secondary | Adverse Events | Self-reported treatment-related and serious adverse events | All subjects that were enrolled were assessed for adverse events at each study visit. Measure is number of participants with event | Posted | Number | participants | over 168 days |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | NuvaRing | intravaginal contraception | 0 | 7 | 0 | 7 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |