Trial · NCT01240811
Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
NCT01240811, Not applicable, Completed, Sharon Achilles; results first posted 2013-07-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception. Trials, record NCT01240811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01240811
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception
- NCT number
- NCT01240811
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 42 participants, actual
- Lead sponsor
- Sharon Achilles
- Conditions
- Genital Tract Mucosal Immunity, Genital Tract Microflora
- Interventions
- IUD placement, Levonorgestrel IUD, Copper T380A IUD
- First posted
- 2010-11-15
- Last updated
- 2017-12-26
- Results first posted
- 2013-07-22
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium | 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 |
| Secondary | Change in Vaginal Flora | 2 Months | 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. |
| Secondary | Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis | 2 Months | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium | 2 months | 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. | % of T-cells expressing CCR5 | MEAN |
| SECONDARY | Change in Vaginal Flora | 2 Months | units on a scale | MEDIAN | |
| SECONDARY | Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis | 2 Months | log gene copies/swab | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium | Control-No IUD | 4.9 | Standard Deviation 17.2 | % of T-cells expressing CCR5 | |
| %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium | Levonorgestrel IUS | 11.7 | Standard Deviation 29.8 | % of T-cells expressing CCR5 | |
| %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium | Copper T380A IUD | 7.2 | Standard Deviation 32.8 | % of T-cells expressing CCR5 | |
| Change in Vaginal Flora | Control-No IUD | 0 | Full Range -7 to 2 | units on a scale | |
| Change in Vaginal Flora | Levonorgestrel IUS | 1 | Full Range -3 to 6 | units on a scale | |
| Change in Vaginal Flora | Copper T380A IUD | 0 | Full Range -8 to 5 | units on a scale | |
| Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis | Control-No IUD | Change in log Lactobacilli quantity | -0.6 | Full Range -4.5 to 3.1 | log gene copies/swab |
| Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis | Levonorgestrel IUS | Change in log Lactobacilli quantity | -0.1 | Full Range -8.3 to 1.0 | log gene copies/swab |
| Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis | Copper T380A IUD | Change in log Lactobacilli quantity | 0.1 | Full Range -3.1 to 5.1 | log gene copies/swab |
| Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis | Control-No IUD | Change in log Garnerella vaginalis quantity | 0 | Full Range -4.0 to 5.1 | log gene copies/swab |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control-No IUD | 8 | |
| Overall Study | STARTED | Levonorgestrel IUS | 17 | |
| Overall Study | STARTED | Copper T380A IUD | 17 | |
| Overall Study | COMPLETED | Control-No IUD | 8 | |
| Overall Study | COMPLETED | Levonorgestrel IUS | 16 | |
| Overall Study | COMPLETED | Copper T380A IUD | 16 | |
| Overall Study | NOT COMPLETED | Control-No IUD | 0 | |
| Overall Study | NOT COMPLETED | Levonorgestrel IUS | 1 | |
| Overall Study | NOT COMPLETED | Copper T380A IUD | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control-No IUD | ||
| Total, all-cause mortality | Levonorgestrel IUS | ||
| Total, all-cause mortality | Copper T380A IUD | ||
| Total, other adverse events | Control-No IUD | 0 | 8 |
| Total, other adverse events | Levonorgestrel IUS | 0 | 17 |
| Total, other adverse events | Copper T380A IUD | 0 | 17 |
| Total, serious adverse events | Control-No IUD | 0 | 8 |
| Total, serious adverse events | Levonorgestrel IUS | 0 | 17 |
| Total, serious adverse events | Copper T380A IUD | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01240811
GET https://conductscience.org/api/trials/v1/NCT01240811/registered