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Hormonal Contraception and Risk of Chlamydia and Gonorrhea - Article


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Depo-provera




Clinical Trial: Hormonal Contraception and Risk of Chlamydia and Gonorrhea

This study has been terminated.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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.

Condition Treatment or Intervention Phase
Chlamydia Infection
Neisseriaceae Infection
 Drug: Depo Medroxyprogesterone acetate
 Drug: Combined oral contraceptives
Phase IV

MedlinePlus related topics:  Bacterial Infections;   Chlamydia Infections

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Hormonal Contraception, Cervical Ectopy, and STDs

Further Study Details: 

Expected Total Enrollment:  1200

Study start: September 1997;  Study completion: August 2001

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 Gonorhea had occurred and to evaluate the extent of cervical ectopy present.

Eligibility

Ages Eligible for Study:  15 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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

Location Information

Study chairs or principal investigators

Charles Morrison, Ph.D.,  Principal Investigator,  Family Health International, RTP, N.C.   
Paul Blumenthal, M.D.,  Principal Investigator,  Maryland Planned Parenthood   

More Information

Study ID Numbers:  HD7034
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  September 16, 2004
ClinicalTrials.gov Identifier:  NCT00091728
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2008



Page Updated: October 3, 2005
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