Trial Outcomes & Findings for Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (NCT NCT01240811)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

2 months

Results posted on

2017-12-26

Participant Flow

Participants were recruited from the medical clinic and our database of prior research participants. Public advertisements included listing on our website, letters to the database mailing list, flyers placed on local college campuses, mailings to faculty, internet postings on Craig's list, and informational booths at on or off campus fairs.

Participant milestones

Participant milestones
Measure	Control-No IUD Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.	Levonorgestrel IUS Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.	Copper T380A IUD Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Overall Study STARTED	8	17	17
Overall Study COMPLETED	8	16	16
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control-No IUD Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.	Levonorgestrel IUS Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.	Copper T380A IUD Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Overall Study Physician Decision	0	1	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control-No IUD n=8 Participants Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.	Levonorgestrel IUS n=17 Participants Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.	Copper T380A IUD n=17 Participants Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	17 Participants n=4 Participants	17 Participants n=27 Participants	42 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	28 years STANDARD_DEVIATION 6 • n=93 Participants	26 years STANDARD_DEVIATION 6 • n=4 Participants	27 years STANDARD_DEVIATION 4 • n=27 Participants	26 years STANDARD_DEVIATION 5 • n=483 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	17 Participants n=4 Participants	17 Participants n=27 Participants	42 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	8 participants n=93 Participants	17 participants n=4 Participants	17 participants n=27 Participants	42 participants n=483 Participants

PRIMARY outcome

Timeframe: 2 months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Control-No IUD n=8 Participants Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.	Levonorgestrel IUS n=16 Participants Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.	Copper T380A IUD n=16 Participants Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium	4.9 % of T-cells expressing CCR5 Standard Deviation 17.2	11.7 % of T-cells expressing CCR5 Standard Deviation 29.8	7.2 % of T-cells expressing CCR5 Standard Deviation 32.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control-No IUD n=8 Participants Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.	Levonorgestrel IUS n=15 Participants Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.	Copper T380A IUD n=16 Participants Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Change in Vaginal Flora	0 units on a scale Interval -7.0 to 2.0	1 units on a scale Interval -3.0 to 6.0	0 units on a scale Interval -8.0 to 5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control-No IUD n=8 Participants Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.	Levonorgestrel IUS n=15 Participants Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.	Copper T380A IUD n=16 Participants Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis Change in log Lactobacilli quantity	-0.6 log gene copies/swab Interval -4.5 to 3.1	-0.1 log gene copies/swab Interval -8.3 to 1.0	0.1 log gene copies/swab Interval -3.1 to 5.1
Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis Change in log Garnerella vaginalis quantity	0 log gene copies/swab Interval -4.0 to 5.1	0 log gene copies/swab Interval -5.1 to 5.9	0 log gene copies/swab Interval -7.1 to 5.5

Adverse Events

Control-No IUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Levonorgestrel IUS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Copper T380A IUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharon Achilles, MD, PhD

University of Pittsburgh

Phone: 412-641-1403

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place