Hormonal Contraception and Vaginal Health

This study has been completed.
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00612508
First received: January 29, 2008
Last updated: October 9, 2012
Last verified: October 2012

January 29, 2008
October 9, 2012
May 2007
May 2008   (final data collection date for primary outcome measure)
Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. [ Time Frame: baseline, 84 days, 168 days ] [ Designated as safety issue: No ]
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
thickness of the vaginal epithelium [ Time Frame: after all 3 biopsies have been collected for one subject ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00612508 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: over 168 days ] [ Designated as safety issue: No ]
Self-reported treatment-related and serious adverse events
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 ]
Not Provided
Not Provided
 
Hormonal Contraception and Vaginal Health
The Effects of Oral vs. Intravaginal Hormonal Contraception on 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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Contraceptive Usage
  • Vaginal Epithelial Disruption
  • Drug: Desogen (ethinyl estradiol and desogestrel)
    1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
    Other Name: Desogen®
  • Drug: NuvaRing (ethinyl estradiol and etonogestrel)
    Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring
    Other Name: NuvaRing®
  • Active Comparator: Desogen

    Drug: ethinyl estradiol and desogestrel

    1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.

    Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles

    Intervention: Drug: Desogen (ethinyl estradiol and desogestrel)
  • Active Comparator: NuvaRing

    Intravaginal Contraception

    ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

    Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles

    Intervention: Drug: NuvaRing (ethinyl estradiol and etonogestrel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2008
May 2008   (final data collection date for primary outcome measure)

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)
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612508
OHSU RES 2017
No
Jeffrey Jensen, Oregon Health and Science University
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Principal Investigator: Jeffrey T Jensen, MD., MPH Oregon Health and Science University
Oregon Health and Science University
October 2012

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