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Hormonal Contraception and Vaginal Health

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraceptive Usage; Vaginal Epithelial Disruption

Intervention: Desogen (ethinyl estradiol and desogestrel) (Drug); NuvaRing (ethinyl estradiol and etonogestrel) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Jeffrey T Jensen, MD., MPH, Principal Investigator, Affiliation: Oregon Health and Science University

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).

Clinical Details

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

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

Primary outcome: Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported.

Secondary outcome: Adverse Events

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

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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)

Locations and Contacts

Oregon Health and Science University, Portland, Oregon 97239, United States
Additional Information

Starting date: May 2007
Last updated: October 9, 2012

Page last updated: August 23, 2015

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