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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


NCT number NCT00091728
Study type Observational
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status Terminated
Phase Phase 4
Start date September 1997
Completion date August 2001

See also
  Status Clinical Trial Phase
Completed NCT00207493 - The Participant Agreement for Contact Tracing (PACT) Study: Enhancing Partner Notification Services. Phase 1/Phase 2
Terminated NCT01291264 - Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM] Phase 4
Withdrawn NCT00578188 - Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract N/A