Hormonal Contraception and Risk of Chlamydia and Gonorrhea

This study has been terminated.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00091728
First received: September 16, 2004
Last updated: November 4, 2005
Last verified: September 2004
  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 Intervention Phase
Chlamydia Infection
Neisseriaceae Infection
Drug: Depo Medroxyprogesterone acetate
Drug: Combined oral contraceptives
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Hormonal Contraception, Cervical Ectopy, and STDs

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 1200
Study Start Date: September 1997
Estimated Study Completion Date: August 2001
Detailed 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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091728

Sponsors and Collaborators
Investigators
Principal Investigator: Charles Morrison, Ph.D. Family Health International, RTP, N.C.
Principal Investigator: Paul Blumenthal, M.D. Maryland Planned Parenthood
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00091728     History of Changes
Other Study ID Numbers: HD7034
Study First Received: September 16, 2004
Last Updated: November 4, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
epidemiology
relative risk
cervical ectopy
hormonal contraceptives
sexually transmitted infections

Additional relevant MeSH terms:
Chlamydia Infections
Neisseriaceae Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014