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Trial record 75 of 1927 for:    Sexually Transmitted Diseases | NIH

Hormonal Contraception and Risk of Chlamydia and Gonorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091728
Recruitment Status : Terminated
First Posted : September 20, 2004
Last Update Posted : November 7, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Condition or disease Intervention/treatment
Chlamydia Infection Neisseriaceae Infection Drug: Depo Medroxyprogesterone acetate Drug: Combined oral contraceptives

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.

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Study Type : Observational
Enrollment : 1200 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Hormonal Contraception, Cervical Ectopy, and STDs
Study Start Date : September 1997
Study Completion Date : August 2001

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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091728

Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Charles Morrison, Ph.D. Family Health International, RTP, N.C.
Principal Investigator: Paul Blumenthal, M.D. Maryland Planned Parenthood

Layout table for additonal information Identifier: NCT00091728     History of Changes
Other Study ID Numbers: HD7034
First Posted: September 20, 2004    Key Record Dates
Last Update Posted: November 7, 2005
Last Verified: September 2004

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

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