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Completed

NCT Number: NCT00612508

Hormonal Contraception and Vaginal Health

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).

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Desogen (ethinyl estradiol and desogestrel)

Drug

1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol

Other names: Desogen®

NuvaRing (ethinyl estradiol and etonogestrel)

Drug

Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Other names: NuvaRing®

Primary outcomes

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

    Time frame: baseline, 84 days, 168 days

    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

Secondary outcomes

  1. Adverse Events

    Time frame: over 168 days

    Self-reported treatment-related and serious adverse events

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Oregon Clinical and Translational Research Institute

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Nov 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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