Hormonal Contraception and Vaginal Health
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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).
| Condition | Intervention |
|---|---|
|
Contraceptive Usage Vaginal Epithelial Disruption |
Drug: Desogen (ethinyl estradiol and desogestrel) Drug: NuvaRing (ethinyl estradiol and etonogestrel) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health |
- Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. [ Time Frame: baseline, 84 days, 168 days ] [ Designated as safety issue: No ]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
- Adverse Events [ Time Frame: over 168 days ] [ Designated as safety issue: No ]Self-reported treatment-related and serious adverse events
| Enrollment: | 14 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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 |
Drug: Desogen (ethinyl estradiol and desogestrel)
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
Other Name: Desogen®
|
|
Active Comparator: 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 |
Drug: NuvaRing (ethinyl estradiol and etonogestrel)
Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
Other Name: NuvaRing®
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts 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)
Contacts and Locations| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Jeffrey T Jensen, MD., MPH | Oregon Health and Science University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jeffrey Jensen, MD MPH, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00612508 History of Changes |
| Other Study ID Numbers: | OHSU RES 2017 |
| Study First Received: | January 29, 2008 |
| Results First Received: | December 16, 2010 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
contraception NuvaRing Desogen vaginal biopsy |
Additional relevant MeSH terms:
|
Estradiol Polyestradiol phosphate Ethinyl Estradiol Desogestrel Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate 3-keto-desogestrel Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Progestins Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 18, 2013