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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Contraceptive Usage Vaginal Epithelial Disruption Drug: Desogen (ethinyl estradiol and desogestrel) Drug: NuvaRing (ethinyl estradiol and etonogestrel) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health
Study Start Date : May 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse Events [ Time Frame: over 168 days ]
    Self-reported treatment-related and serious adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612508


Locations
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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
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Principal Investigator: Jeffrey T Jensen, MD., MPH Oregon Health and Science University
More Information
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Additional Information:

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Responsible Party: Jeffrey Jensen, MD MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00612508    
Other Study ID Numbers: OHSU RES 2017
First Posted: February 11, 2008    Key Record Dates
Results First Posted: November 8, 2012
Last Update Posted: November 8, 2012
Last Verified: October 2012
Keywords provided by Jeffrey Jensen, Oregon Health and Science University:
contraception
NuvaRing
Desogen
vaginal biopsy
Additional relevant MeSH terms:
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Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Ethinyl Estradiol
Etonogestrel
Desogestrel
NuvaRing
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Progestins