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Hormonal Contraception and Vaginal Health

NCT ID: NCT00612508

Last Updated: 2012-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Contraceptive Usage Vaginal Epithelial Disruption

Keywords

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contraception NuvaRing Desogen vaginal biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Desogen (ethinyl estradiol and desogestrel)

Intervention Type DRUG

1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol

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

Group Type ACTIVE_COMPARATOR

NuvaRing (ethinyl estradiol and etonogestrel)

Intervention Type DRUG

Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Interventions

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Desogen (ethinyl estradiol and desogestrel)

1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol

Intervention Type DRUG

NuvaRing (ethinyl estradiol and etonogestrel)

Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Intervention Type DRUG

Other Intervention Names

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Desogen® NuvaRing®

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Clinical and Translational Research Institute

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Jensen

MD MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey T Jensen, MD., MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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http://www.ohsuwomenshealth.com/research/index.html

(Women's Health Research Unit website)

Other Identifiers

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OHSU RES 2017

Identifier Type: -

Identifier Source: org_study_id