Hormonal Contraception and Vaginal Health

Contraceptive Usage Clinical Trial

Official title:

The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612508
• Other study ID #: OHSU RES 2017
• Status: Completed
• Phase: N/A
• First received: January 29, 2008
• Last updated: October 9, 2012
• Start date: May 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2012
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contraceptive Usage
• Vaginal Epithelial Disruption

Intervention

Drug:
• Desogen (ethinyl estradiol and desogestrel)
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
• NuvaRing (ethinyl estradiol and etonogestrel)
Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Oregon Clinical and Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.	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	baseline, 84 days, 168 days	No
Secondary	Adverse Events	Self-reported treatment-related and serious adverse events	over 168 days	No