Genital Tract Mucosal ImmunityCHICNCT01240811

Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception

A study testing IUD placement, Levonorgestrel IUD and Copper T380A IUD in people with Genital Tract Mucosal Immunity and Genital Tract Microflora, run by Sharon Achilles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors). Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Genital Tract Mucosal Immunity, Genital Tract Microflora
What is being tested?: IUD placement, Levonorgestrel IUD and Copper T380A IUD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Nov 2010to Nov 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Non-pregnant, healthy females who are seeking an IUD for contraception
Age 18-40 years, inclusive at the time of enrollment
History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
Willing and able to sign the informed consent and to comply with the study protocol
Non-pregnant, healthy females
Age 18-40 years, inclusive at the time of enrollment

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History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
Willing and able to sign the informed consent and to comply with the study protocol
Prior surgical sterilization or heterosexually abstinent

Who cannot join

Use of any hormonal or intrauterine contraceptive method within the past two months
Use of DMPA within the past 10 months
Any of the following within the past two months:
Pregnancy or breastfeeding
Surgery/biopsy of the vulva, vagina, or cervix
History of STI

Show all 21Show fewer

New sexual partner
Evidence of vaginal/pelvic infection on screening
Abnormal wet mount (see description above)
Pelvic exam findings clinically consistent with infection
Positive screen for Gc, Ct, or HIV (will be excluded post randomization)
Active HSV/ulcerative disease in the genital tract or perineum
History of immunosuppression (diabetes, HIV, chronic steroid use)
Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days
Use of any systemic or vaginal steroid or antibiotic within the past 30 days
Vaginal or anal intercourse within 1 week of sample collection
Heterosexual vaginal intercourse since last menses without condom use
History of hysterectomy
History of malignancy in the uterus or cervix
Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)
Allergy to copper and/or intolerance to levonorgestrel

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract

Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.

The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.

Conditions: Genital Tract Mucosal Immunity, Genital Tract Microflora
Being tested: IUD placement, Levonorgestrel IUD, Copper T380A IUD
Keywords: intrauterine device, IUD, levonorgestrel, copper, CD4, CCR5, microflora

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IUD placementDrug
Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).
Levonorgestrel IUDDrug
Also called Mirena IUD
Copper T380A IUDDrug
Also called ParaGard IUD

Study groups in NCT01240811
Study group	Role	What they receive
Control-No IUD	No intervention	Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Levonorgestrel IUS	Experimental	Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS. Receives: Drug: IUD placement; Drug: Levonorgestrel IUD
Copper T380A IUD	Experimental	Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD. Receives: Drug: IUD placement; Drug: Copper T380A IUD

What is being measured

The primary outcome is the main question the study is designed to answer.

%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety
Measured: 2 months

Secondary outcomes (2)

Change in Vaginal Flora
Changes in vaginal flora as assessed by Nugent score The Nugent score is calculated by microscopically assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with bacterial vaginosis, 4-6 is consistent with intermediate vaginal flora, and 0-3 is normal vaginal flora.
Measured: 2 Months
Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis
Changes in vaginal flora as assessed by qPCR quantitation of H2O2 producing Lactobacilli species and Gardnerella vaginalis. Quantitative PCR (qPCR) results are reported as log concentration of gene copies/swab specimen.
Measured: 2 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Nov 2011

First posted15 Nov 2010 (estimated)
Study startNov 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Genital Tract Mucosal ImmunityStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01240811
Sponsor's protocol ID: PRO09100199
Acronym: CHIC
Status last verified: Nov 2017
First submitted: 11 Nov 2010
Last updated: 26 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract
ClinicalTrials.gov ID: NCT01240811
Acronym / sponsor ID: CHIC / PRO09100199
Conditions: Genital Tract Mucosal Immunity, Genital Tract Microflora
Keywords: intrauterine device, IUD, levonorgestrel, copper, CD4, CCR5, microflora
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Sharon AchillesUniversity, hospital or other
Study start: Nov 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 15 Nov 2010 (estimated)
Results: Posted 22 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control-No IUD	No intervention	–Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
Levonorgestrel IUS	Experimental	Drug: IUD placement, Drug: Levonorgestrel IUDHealthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Copper T380A IUD	Experimental	Drug: IUD placement, Drug: Copper T380A IUDHealthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Non-pregnant, healthy females who are seeking an IUD for contraception
Age 18-40 years, inclusive at the time of enrollment
History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
Willing and able to sign the informed consent and to comply with the study protocol
Non-pregnant, healthy females

Key exclusion criteria (21 listed)

Use of any hormonal or intrauterine contraceptive method within the past two months
Use of DMPA within the past 10 months
Any of the following within the past two months:
Evidence of vaginal/pelvic infection on screening
Active HSV/ulcerative disease in the genital tract or perineum

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
IUD placementVolunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).	Drug	Copper T380A IUD, Levonorgestrel IUS
Levonorgestrel IUDAlso: Mirena IUD	Drug	Levonorgestrel IUS
Copper T380A IUDAlso: ParaGard IUD	Drug	Copper T380A IUD

Primary outcome

%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
Time frame: 2 months
Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety

2 secondary outcomes

Change in Vaginal Flora
Time frame: 2 Months
Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis
Time frame: 2 Months

Results and safety

Results posted to the registry on 22 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control-No IUD	8	8
Levonorgestrel IUS	17	16
Copper T380A IUD	17	16

Primary outcome: %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium

Time frame: 2 months. Mean (Standard Deviation). Unit: % of T-cells expressing CCR5

Measure	Control-No IUD n = 8	Levonorgestrel IUS n = 16	Copper T380A IUD n = 16
Value	4.9 (17.2)	11.7 (29.8)	7.2 (32.8)

Control-No IUD vs Levonorgestrel IUS: p = 0.80, ANOVA
Control-No IUD vs Copper T380A IUD: p = 0.97, ANOVA

Population analysed: All 40 participants who completed the study were included in the analysis. There were no lost-to-follow up participants. One participant withdrew and one participant was excluded post-enrollment. Both of these participants were replaced to fill our goal enrollment of 40 participants in the study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control-No IUD	0 of 8 (0%)	0 of 8 (0%)	Not reported
Levonorgestrel IUS	0 of 17 (0%)	0 of 17 (0%)	Not reported
Copper T380A IUD	0 of 17 (0%)	0 of 17 (0%)	Not reported

Limitations and caveats (from the sponsor): We identified a need for methods optimization prior to proceeding with a large definitive study to determine contraceptive hormone induced changes in genital tract immune cell populations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Sharon Achilles, MD, PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing IUD placement, Levonorgestrel IUD and Copper T380A IUD in people with Genital Tract Mucosal Immunity and Genital Tract Microflora, run by Sharon Achilles at 1 site in United States.

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 9 inclusion and 21 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: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 22 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01240811.

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 26 Dec 2017.