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Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers

Primary Purpose

Vaginosis, Bacterial

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring

About this trial

This is an interventional treatment trial for Vaginosis, Bacterial focused on measuring Contraception, Nuvaring, Vaginal inflammation, Bacterial vaginosis, Nugent score

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women (age 18 - 45) interested in using NuvaRing® for contraception for 3 or more months, and women who are not at risk for pregnancy (i.e. abstinent, tubal sterilization, partner with vasectomy)
Women with a normal menstrual cycle (21-35 days) for the past three cycles
Women with normal pelvic anatomy (by physical exam)
Negative urine pregnancy test
Normal pap smear within the past 12 months

Exclusion Criteria:

Pregnancy
Current breastfeeding
Less than 6 weeks post partum
Current IUD or Implanon use
Depot Medroxyprogesterone Acetate use within the past 6 months
Current diagnosis of uterine infection
Use of hormonal contraception within the past 30 days
Current cervical dysplasia
Chronic immune suppression
Chronic use of immune suppressors such as steroids
Chronic antibiotic use
Diabetes or fasting blood glucose >105
Hysterectomy
Uncontrolled hypertension (systolic BP≥140/ diastolic BP≥ 90)
Migraine headaches complicated by aura or focal neurologic deficits
Menopause
Standard contraindications to combined oral contraceptive use (thrombophilia, active liver disease, active deep venous thrombosis, history of thrombosis)
Use of tobacco products ≥ 35 years of age
Two or more symptomatic genital herpes simplex virus (HSV) outbreaks in past 12 months
Human immunodeficiency virus
Vulvovaginal candidiasis
Trichamonas vaginalis
Neisseria gonorrhea
Chlamydia trachomatis
Bacterial vaginosis
Nugent scores of 4 or greater
Use of any other study medication within the past 30 days

Sites / Locations

Clinical Research Center at Eastern Virginia Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nuvaring

Arm Description

This is a single-group study in which data points after use of the etonogestrel/ethinyl estradiol vaginal ring will be compared to baseline.

Outcomes

Primary Outcome Measures

Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) after 3 months of NuvaRing® use

Secondary Outcome Measures

Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing®

Full Information

NCT ID

NCT01448291

First Posted

July 8, 2011

Last Updated

April 23, 2012

Sponsor

Eastern Virginia Medical School

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01448291

Brief Title

Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers

Official Title

The Effects of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) on Vaginal Innate and Inflammatory Biomarkers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

October 2012 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eastern Virginia Medical School

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

It is not known if the use of NuvaRing® alters these innate and inflammatory biomarkers of inflammation. Hypothesis: The hypothesis is that NuvaRing® will alter inflammatory biomarkers of inflammation, such as vaginal defensin and cytokine levels, resulting in an overall anti-inflammatory milieu in the vagina. Specific aims of this study are to: Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration before and after treatment with NuvaRing® Monitor for changes in the Nugent score before and after NuvaRing® use Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use Methods This is a prospective, open-label, nonrandomized study. Participants will serve as their own controls. The Clinical Research Center of Eastern Virginia Medical School, Norfolk, Virginia, U.S.A. will be the only study site.

Detailed Description

To complete specific aim #1, the investigators will use commercially available elisa kits to measure human defensins, inflammatory cytokines, and anti-inflammatory cytokines in vaginal fluid washings collected before and after use of NuvaRing. To complete specific aim #2, the investigators will collect biopsies of the uterine cervix before and after NuvaRing use. Specimens will undergo histopathological measures for overall appearance, epithelial integrity, epithelial thickness, leukocyte infiltration, congestion, and edema. The investigators will quantitate the number of CD45+ and NFkB+ cells using immunohistology in the cervical epithelium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginosis, Bacterial

Keywords

Contraception, Nuvaring, Vaginal inflammation, Bacterial vaginosis, Nugent score

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nuvaring

Arm Type

Experimental

Arm Description

This is a single-group study in which data points after use of the etonogestrel/ethinyl estradiol vaginal ring will be compared to baseline.

Intervention Type

Drug

Intervention Name(s)

Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring

Other Intervention Name(s)

NuvaRing®

Intervention Description

Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months

Primary Outcome Measure Information:

Title

Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) after 3 months of NuvaRing® use

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration after 3 months of treatment with NuvaRing®

Time Frame

Baseline and 3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women (age 18 - 45) interested in using NuvaRing® for contraception for 3 or more months, and women who are not at risk for pregnancy (i.e. abstinent, tubal sterilization, partner with vasectomy) Women with a normal menstrual cycle (21-35 days) for the past three cycles Women with normal pelvic anatomy (by physical exam) Negative urine pregnancy test Normal pap smear within the past 12 months Exclusion Criteria: Pregnancy Current breastfeeding Less than 6 weeks post partum Current IUD or Implanon use Depot Medroxyprogesterone Acetate use within the past 6 months Current diagnosis of uterine infection Use of hormonal contraception within the past 30 days Current cervical dysplasia Chronic immune suppression Chronic use of immune suppressors such as steroids Chronic antibiotic use Diabetes or fasting blood glucose >105 Hysterectomy Uncontrolled hypertension (systolic BP≥140/ diastolic BP≥ 90) Migraine headaches complicated by aura or focal neurologic deficits Menopause Standard contraindications to combined oral contraceptive use (thrombophilia, active liver disease, active deep venous thrombosis, history of thrombosis) Use of tobacco products ≥ 35 years of age Two or more symptomatic genital herpes simplex virus (HSV) outbreaks in past 12 months Human immunodeficiency virus Vulvovaginal candidiasis Trichamonas vaginalis Neisseria gonorrhea Chlamydia trachomatis Bacterial vaginosis Nugent scores of 4 or greater Use of any other study medication within the past 30 days

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julia Caul

Phone

7574465808

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas D Kimble, MD

Organizational Affiliation

Eastern Virginia Medical School/CONRAD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Center at Eastern Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julia Caul

Phone

757-446-5808

12. IPD Sharing Statement

Citations:

PubMed Identifier

18154595

Citation

Iqbal SM, Kaul R. Mucosal innate immunity as a determinant of HIV susceptibility. Am J Reprod Immunol. 2008 Jan;59(1):44-54. doi: 10.1111/j.1600-0897.2007.00563.x.

Results Reference

background

PubMed Identifier

12237628

Citation

Valore EV, Park CH, Igreti SL, Ganz T. Antimicrobial components of vaginal fluid. Am J Obstet Gynecol. 2002 Sep;187(3):561-8. doi: 10.1067/mob.2002.125280.

Results Reference

background

PubMed Identifier

18635180

Citation

Fan SR, Liu XP, Liao QP. Human defensins and cytokines in vaginal lavage fluid of women with bacterial vaginosis. Int J Gynaecol Obstet. 2008 Oct;103(1):50-4. doi: 10.1016/j.ijgo.2008.05.020. Epub 2008 Jul 16.

Results Reference

background

PubMed Identifier

16235171

Citation

John M, Keller MJ, Fam EH, Cheshenko N, Hogarty K, Kasowitz A, Wallenstein S, Carlucci MJ, Tuyama AC, Lu W, Klotman ME, Lehrer RI, Herold BC. Cervicovaginal secretions contribute to innate resistance to herpes simplex virus infection. J Infect Dis. 2005 Nov 15;192(10):1731-40. doi: 10.1086/497168. Epub 2005 Oct 13.

Results Reference

background

PubMed Identifier

17911138

Citation

Cherpes TL, Marrazzo JM, Cosentino LA, Meyn LA, Murray PJ, Hillier SL. Hormonal contraceptive use modulates the local inflammatory response to bacterial vaginosis. Sex Transm Infect. 2008 Feb;84(1):57-61. doi: 10.1136/sti.2007.026625. Epub 2007 Oct 2.

Results Reference

background

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Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers

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