Hormonal Contraception and Risk of Chlamydia and Gonorrhea

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

TERMINATED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-09-30

Study Completion Date

2001-08-31

Brief Summary

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There are biological reasons to suspect that hormones may affect the risk of a woman becoming infected with a sexually transmitted disease. The evidence on this issue to date is mixed and previous studies have methodologic flaws making it difficult to draw conclusions about the results.

This study compares the risk of developing either Chlamydial or Gonorrheal infection among three groups of women: those using combined oral contraceptives (birth control pills); those using the injectable hormone (brand name Depo Provera); and those women using non-hormonal contraceptive methods.

Detailed Description

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The study was designed to examine the relationship between hormonal contraceptive use and possible increased risk of Chlamydial and Gonococcal sexually transmitted infections, and to determine if any increased risk appeared to be mediated by the extent of cervical ectopy.

Eight hundred and nineteen women, ages 15 to 45 years, were recruited from an inner city clinic and from a nearby suburban clinic. The women were classified into three groups based on type of contraceptive used. One group used oral contraceptives; the second used injectable depo-medroxyprogesterone acetate (DMPA); and the third group used non-hormonal contraceptive methods. Women from each group were followed at 3, 6, and 12 months after enrollment to determine if a new infection with Chlamydia or Gonorrhea had occurred and to evaluate the extent of cervical ectopy present.

Conditions

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Chlamydia Infection Neisseriaceae Infection

Keywords

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epidemiology relative risk cervical ectopy hormonal contraceptives sexually transmitted infections

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Depo Medroxyprogesterone acetate

Intervention Type DRUG

Combined oral contraceptives

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female age 15 to 45 years
* no hormone use at enrollment
* not pregnant or planning pregnancy

Exclusion Criteria

* Cervical cancer presently or in history
* hysterectomy, cone biopsy, or cervical cryotherapy

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Charles Morrison, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Family Health International, RTP, N.C.

Paul Blumenthal, M.D.