N/A N=14 Randomized

Hormonal Contraception and Vaginal Health

Contraceptive Usage · Vaginal Epithelial Disruption

Bottom Line

View on ClinicalTrials.gov: NCT00612508 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. — 0.01; -0.005; -0.02; .007 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Desogen (ethinyl estradiol and desogestrel) (Drug); NuvaRing (ethinyl estradiol and etonogestrel) (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.	0.01; -0.005; -0.02; .007	—
SECONDARY Adverse Events	1; 0	—

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).

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00612508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.