Hormonal Contraception & Vaginal Health
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginal Health
Intervention: ethinyl estradiol and desogestrel (Drug); ethinyl estradiol and etonogestrel (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
Jeffrey T Jensen, MD., MPH, Principal Investigator, Affiliation: Oregon Health and Science University
Overall contact:
Women's Health Research Unit Confidential Recruitment Line, Phone: (503) 494-3666, Email: whru@ohsu.edu
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. We plan to
compare an oral route (taking birth control pills) with a vaginal route (using a vaginal
ring).
Clinical Details
Official title: The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
Study design: Other, Randomized, Open Label, Parallel Assignment
Primary outcome: thickness of the vaginal epithelium
Secondary outcome: number and distribution of immune receptive cells in the vaginal epithelium
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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)
Locations and Contacts
Women's Health Research Unit Confidential Recruitment Line, Phone: (503) 494-3666, Email: whru@ohsu.edu
Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Keren Rosenblum, MD, Sub-Investigator
Alison Edelman, MD., MPH, Sub-Investigator
Mark Nichols, M.D., Sub-Investigator
Paula Bednarek, M.D., Sub-Investigator
Terry Morgan, M.D., Sub-Investigator
Additional Information
(Women's Health Research Unit website)
Starting date: May 2007
Ending date: July 2008
Last updated: January 29, 2008
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