Hormonal Contraception and Risk of Chlamydia and Gonorrhea

Chlamydia Infection Clinical Trial

Official title:

Hormonal Contraception, Cervical Ectopy, and STDs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00091728
• Other study ID #: HD7034
• Status: Terminated
• Phase: Phase 4
• First received: September 16, 2004
• Last updated: November 4, 2005
• Start date: September 1997
• Est. completion date: August 2001

Study information

• Verified date: September 2004
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: August 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Chlamydia Infection
• Chlamydia Infections
• Communicable Diseases
• Infection
• Neisseriaceae Infection

Intervention

Drug:
• Depo Medroxyprogesterone acetate

• Combined oral contraceptives

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)