Modulation of Immunity by Hormonal Contraceptives

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

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Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).

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Detailed Description

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Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.

Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mirena

Women interested in beginning use of Mirena

No interventions assigned to this group

Depot-medroxyprogesterone acetate

Women interested in beginning use of depot-medroxyprogesterone acetate

No interventions assigned to this group

Oral Contraception

Women interested in beginning use of oral contraception

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* not pregnant
* regular menstrual cycle

Exclusion Criteria

* use of oral contraceptive or Mirena in 3 months prior to enrollment
* use of depot-medroxyprogesterone acetate in 6 months prior to enrollment
* diagnosis of sexually transmitted infection in 30 days prior to enrollment
* history of cervical malignancy

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes