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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
  Purpose

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).


Condition Intervention
Contraceptive Usage
Vaginal Epithelial Disruption
Drug: Desogen (ethinyl estradiol and desogestrel)
Drug: NuvaRing (ethinyl estradiol and etonogestrel)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: over 168 days ] [ Designated as safety issue: No ]
    Self-reported treatment-related and serious adverse events


Enrollment: 14
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Drug: Desogen (ethinyl estradiol and desogestrel)
1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
Other Name: Desogen®
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

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®

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612508

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Investigators
Principal Investigator: Jeffrey T Jensen, MD., MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jeffrey Jensen, MD MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00612508     History of Changes
Other Study ID Numbers: OHSU RES 2017
Study First Received: January 29, 2008
Results First Received: December 16, 2010
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
contraception
NuvaRing
Desogen
vaginal biopsy

Additional relevant MeSH terms:
3-keto-desogestrel
Desogestrel
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014