Hormonal Contraception and Vaginal Health

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2008

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

  • Drug: Desogen (ethinyl estradiol and desogestrel)
    • 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
  • Drug: NuvaRing (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

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Adverse Events
    • Time Frame: over 168 days
    • Self-reported treatment-related and serious adverse events

Participating in This Clinical Trial

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: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Collaborator
    • Oregon Clinical and Translational Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeffrey Jensen, MD MPH – Oregon Health and Science University
  • Overall Official(s)
    • Jeffrey T Jensen, MD., MPH, Principal Investigator, Oregon Health and Science University

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