Hormonal Contraception and Vaginal Health - Tabular View

Tracking Information

First Received Date ^ICMJE

January 29, 2008

Last Updated Date

February 5, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

thickness of the vaginal epithelium [ Time Frame: after all 3 biopsies have been collected for one subject ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00612508 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

number and distribution of immune receptive cells in the vaginal epithelium [ Time Frame: after all 3 biospies have been collected for one subject ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Hormonal Contraception and Vaginal Health

Official Title ^ICMJE

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

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

Vaginal Health

Intervention ^ICMJE

Drug: ethinyl estradiol and desogestrel
Drug: ethinyl estradiol and etonogestrel

Study Arms / Comparison Groups

Active Comparator: oral contraceptive
Active Comparator: intravaginal contraception

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00612508

Responsible Party

Jeffrey Jensen, MD, MPH, OHSU

Study ID Numbers ^ICMJE

OHSU RES 2017

Study Sponsor ^ICMJE

Oregon Health and Science University

Collaborators ^ICMJE

Oregon Clinical and Translational Research Institute
Women's Health Research Unit

Investigators ^ICMJE

Principal Investigator:

Jeffrey T Jensen, MD., MPH

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP