Official Title: “The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health”

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. We plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: July 2008

We 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.

Intervention(s) in this Clinical Trial

• Drug: ethinyl estradiol and desogestrel
  • 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
• Drug: ethinyl estradiol and etonogestrel
  • Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • oral contraceptive
• Active Comparator: 2
  • intravaginal contraception

Primary Measures

• thickness of the vaginal epithelium
  • Time Frame: after all 3 biopsies have been collected for one subject
    Safety Issue?: No

Secondary Measures

• number and distribution of immune receptive cells in the vaginal epithelium
  • Time Frame: after all 3 biospies have been collected for one subject
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Oregon Health and Science University

Overall Clinical Trial Officials and Contacts

Jeffrey T Jensen, MD., MPH Principal Investigator Oregon Health and Science University  

Overall Contact: Women's Health Research Unit Confidential Recruitment Line (503) 494-3666 whru@ohsu.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612508

Study ID Number: OHSU RES 2017

ClinicalTrials.gov Identifier: NCT00612508

Health Authority: United States: Institutional Review Board

(Women's Health Research Unit website)