Status:
COMPLETED
Hormonal Contraception and Vaginal Health
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Oregon Clinical and Translational Research Institute
Conditions:
Contraceptive Usage
Vaginal Epithelial Disruption
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief 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. The investigators plan to compa...
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 un...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00612508
Start Date
May 1 2007
End Date
May 1 2008
Last Update
November 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oregon Health and Science University
Portland, Oregon, United States, 97239