NCT00091728

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1997

Longer than P75 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2004

Completed
Last Updated

November 7, 2005

Status Verified

September 1, 2004

First QC Date

September 16, 2004

Last Update Submit

November 4, 2005

Conditions

Chlamydia InfectionNeisseriaceae Infection

Keywords

epidemiologyrelative riskcervical ectopyhormonal contraceptivessexually transmitted infections

Interventions

Depo Medroxyprogesterone acetateDRUG
Combined oral contraceptivesDRUG

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female age 15 to 45 years
  • no hormone use at enrollment
  • not pregnant or planning pregnancy

You may not qualify if:

  • Cervical cancer presently or in history
  • hysterectomy, cone biopsy, or cervical cryotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chlamydia InfectionsNeisseriaceae InfectionsSexually Transmitted Diseases

Interventions

Medroxyprogesterone AcetateContraceptives, Oral, Combined

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialCommunicable DiseasesGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsContraceptives, OralContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Charles Morrison, Ph.D.

    Family Health International, RTP, N.C.

    PRINCIPAL INVESTIGATOR

  • Paul Blumenthal, M.D.

    Maryland Planned Parenthood

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2004

First Posted

September 20, 2004

Study Start

September 1, 1997

Study Completion

August 1, 2001

Last Updated

November 7, 2005

Record last verified: 2004-09