Chlamydia InfectionNCT00091728
Hormonal Contraception and Risk of Chlamydia and Gonorrhea
An observational study of Chlamydia Infection and Neisseriaceae Infection, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Infection, Neisseriaceae Infection
- What is being tested?
- Depo Medroxyprogesterone acetate and Combined oral contraceptives
- Type of treatment
- Pill or oral medicine
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Sep 1997to Aug 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female age 15 to 45 years
- no hormone use at enrollment
- not pregnant or planning pregnancy
Who cannot join
- Cervical cancer presently or in history
- hysterectomy, cone biopsy, or cervical cryotherapy
About this study
Official title: Hormonal Contraception, Cervical Ectopy, and STDs
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.
Read the 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.
- Conditions
- Chlamydia Infection, Neisseriaceae Infection
- Being tested
- Depo Medroxyprogesterone acetate, Combined oral contraceptives
- Keywords
- epidemiology, relative risk, cervical ectopy, hormonal contraceptives, sexually transmitted infections
- Medical subject headings
- Chlamydia Infections, Neisseriaceae Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo Medroxyprogesterone acetateDrug
Combined oral contraceptivesDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2004 (estimated)
- Study startSep 1997
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Charles Morrison, Ph.D., Principal investigator, Family Health International, RTP, N.C.Paul Blumenthal, M.D., Principal investigator, Maryland Planned Parenthood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091728
- Sponsor's protocol ID
- HD7034
- Status last verified
- Sep 2004
- First submitted
- 16 Sep 2004
- Last updated
- 7 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Contraception, Cervical Ectopy, and STDs
- ClinicalTrials.gov ID
- NCT00091728
- Acronym / sponsor ID
- HD7034
- Conditions
- Chlamydia Infection, Neisseriaceae Infection
- Keywords
- epidemiology, relative risk, cervical ectopy, hormonal contraceptives, sexually transmitted infections
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,200 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 1997
- Study completion
- Aug 2001
- First posted
- 20 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female age 15 to 45 years
- no hormone use at enrollment
- not pregnant or planning pregnancy
Key exclusion criteria (2 listed)
- Cervical cancer presently or in history
- hysterectomy, cone biopsy, or cervical cryotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depo Medroxyprogesterone acetate | Drug | – |
| Combined oral contraceptives | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Morrison, Ph.D. principal investigator
Family Health International, RTP, N.C.
Paul Blumenthal, M.D. principal investigator
Maryland Planned Parenthood
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia Infection and Neisseriaceae Infection, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2005.