Clinical trial NCT00612508: Hormonal Contraception and Vaginal Health
Official title: The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Vaginal Epithelial Disruption
Keywords: contraception
NuvaRing
Desogen
vaginal biopsy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon Clinical and Translational Research Institute
First posted: 2008-02-11
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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 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)

Primary outcomes:
measure: Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.
timeFrame: baseline, 84 days, 168 days
Secondary outcomes:
measure: Adverse Events
timeFrame: over 168 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jeffrey T Jensen, MD., MPH
role: PRINCIPAL_INVESTIGATOR
References: