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Hormonal Contraception and Vaginal Health

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ClinicalTrials.gov Identifier: NCT00612508
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE January 29, 2008
First Posted Date  ICMJE February 11, 2008
Results First Submitted Date  ICMJE December 16, 2010
Results First Posted Date  ICMJE November 8, 2012
Last Update Posted Date November 8, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
thickness of the vaginal epithelium [ Time Frame: after all 3 biopsies have been collected for one subject ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
Adverse Events [ Time Frame: over 168 days ]
Self-reported treatment-related and serious adverse events
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2008)
number and distribution of immune receptive cells in the vaginal epithelium [ Time Frame: after all 3 biospies have been collected for one subject ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Contraceptive Usage
  • Vaginal Epithelial Disruption
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2009)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2008)
30
Actual Study Completion Date  ICMJE May 2008
Actual 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00612508
Other Study ID Numbers  ICMJE OHSU RES 2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Jensen, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Oregon Clinical and Translational Research Institute
Investigators  ICMJE
Principal Investigator: Jeffrey T Jensen, MD., MPH Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date October 2012

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