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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00091728 |
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 IV |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Hormonal Contraception, Cervical Ectopy, and STDs |
| Estimated Enrollment: | 1200 |
| Study Start Date: | September 1997 |
| Estimated Study Completion Date: | 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 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | HD7034 |
| Study First Received: | September 16, 2004 |
| Last Updated: | November 4, 2005 |
| ClinicalTrials.gov Identifier: | NCT00091728 |
| Health Authority: | United States: Federal Government |
|
epidemiology relative risk cervical ectopy hormonal contraceptives sexually transmitted infections |
|
Genital Diseases, Female Bacterial Infections Medroxyprogesterone 17-Acetate Sexually Transmitted Diseases Chlamydia Infections |
Medroxyprogesterone Gonorrhea Genital Diseases, Male Gram-Negative Bacterial Infections Neisseriaceae Infections |
|
Communicable Diseases Sexually Transmitted Diseases, Bacterial Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female |
Reproductive Control Agents Infection Contraceptive Agents, Male Pharmacologic Actions Chlamydiaceae Infections Therapeutic Uses Contraceptives, Oral, Synthetic |
