Hormonal Contraception and Vaginal Health - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University Oregon Clinical and Translational Research Institute Women's Health Research Unit
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00612508

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. We plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

Condition	Intervention
Vaginal Health	Drug: ethinyl estradiol and desogestrel Drug: ethinyl estradiol and etonogestrel

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Desogestrel Etonogestrel Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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

Primary Outcome Measures:

thickness of the vaginal epithelium [ Time Frame: after all 3 biopsies have been collected for one subject ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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
1: Active Comparator oral contraceptive	Drug: ethinyl estradiol and desogestrel 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol
2: Active Comparator intravaginal contraception	Drug: ethinyl estradiol and etonogestrel Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Detailed Description:

We 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

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

Women's Health Research Unit

Investigators

Principal Investigator:

Jeffrey T Jensen, MD., MPH

Oregon Health and Science University

More Information

Additional Information:

(Women's Health Research Unit website) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	OHSU ( Jeffrey Jensen, MD, MPH )
Study ID Numbers:	OHSU RES 2017
Study First Received:	January 29, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00612508 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

contraception
NuvaRing
Desogen
vaginal biopsy

Study placed in the following topic categories:

Estrogens
Contraceptive Agents
Benzoates
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol

Estradiol 17 beta-cypionate
Hormones
Estradiol
Desogestrel
Progestins
Estradiol 3-benzoate
3-keto-desogestrel
Polyestradiol phosphate

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Reproductive Control Agents
Estradiol 17 beta-cypionate

Hormones
Estradiol
Pharmacologic Actions
Desogestrel
Progestins
Therapeutic Uses
Estradiol 3-benzoate
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
3-keto-desogestrel

ClinicalTrials.gov processed this record on July 02, 2009