CClinicalTrials.gg
Sign In
Status unknownNCT01448291Updated Apr 24, 2012

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

A Phase 4 interventional study of Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring in Vaginosis, Bacterial, sponsored by Eastern Virginia Medical School. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-24.

Sponsored by Eastern Virginia Medical School · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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:

  1. Determine biomarkers of inflammation, including defensins and cytokines, concentrations in women with normal vaginal flora (Nugent Score 0 - 3) before and after NuvaRing® use
  2. Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration before and after treatment with NuvaRing®
  3. Monitor for changes in the Nugent score before and after NuvaRing® use
  4. Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use
  5. 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.

Read the detailed description
  1. 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.
  2. 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.
02

Conditions studied

  • Vaginosis, Bacterial

Keywords

  • Contraception
  • Nuvaring
  • Vaginal inflammation
  • Bacterial vaginosis
  • Nugent score
03

In context

Vaginosis, Bacterial

220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.

Browse Vaginosis, Bacterial studies →

Lead sponsor

Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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)
  2. Women with a normal menstrual cycle (21-35 days) for the past three cycles
  3. Women with normal pelvic anatomy (by physical exam)
  4. Negative urine pregnancy test
  5. Normal pap smear within the past 12 months

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Current breastfeeding
  3. Less than 6 weeks post partum
  4. Current IUD or Implanon use
  5. Depot Medroxyprogesterone Acetate use within the past 6 months
  6. Current diagnosis of uterine infection
  7. Use of hormonal contraception within the past 30 days
  8. Current cervical dysplasia
  9. Chronic immune suppression
  10. Chronic use of immune suppressors such as steroids
  11. Chronic antibiotic use
  12. Diabetes or fasting blood glucose >105
  13. Hysterectomy
  14. Uncontrolled hypertension (systolic BP≥140/ diastolic BP≥ 90)
  15. Migraine headaches complicated by aura or focal neurologic deficits
  16. Menopause
  17. Standard contraindications to combined oral contraceptive use (thrombophilia, active liver disease, active deep venous thrombosis, history of thrombosis)
  18. Use of tobacco products ≥ 35 years of age
  19. Two or more symptomatic genital herpes simplex virus (HSV) outbreaks in past 12 months
  20. Human immunodeficiency virus
  21. Vulvovaginal candidiasis
  22. Trichamonas vaginalis
  23. Neisseria gonorrhea
  24. Chlamydia trachomatis
  25. Bacterial vaginosis
  26. Nugent scores of 4 or greater
  27. Use of any other study medication within the past 30 days
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Nuvaring

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

    Drug: Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring

Interventions

  • DrugEtonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring

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

    Also known as: NuvaRing®

06

What researchers measure

Primary outcomes

  1. 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 outcomes

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

    Time frame: Baseline and 3 months

07

Study locations

1 of 1 sites recruiting
  • Clinical Research Center at Eastern Virginia Medical School
    Norfolk, Virginia 23507, United States
    • Julia Caul · Contact · 757-446-5808
    Recruiting
08

References and documents

Publications

  • 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. PubMed 18154595 ↗
  • 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. PubMed 12237628 ↗
  • 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. PubMed 18635180 ↗
  • 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. PubMed 16235171 ↗
  • 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. PubMed 17911138 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01448291
Lead sponsor
Eastern Virginia Medical School
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Thomas Kimble (Assistant Professor, Eastern Virginia Medical School) — Principal investigator
First posted
Oct 7, 2011
Start date
Oct 2011
Primary completion
Oct 2012 (estimated)
Completion
Mar 2013 (estimated)
Last update
Apr 24, 2012

Study contacts

Julia Caul
Contact
7574465808
Thomas D Kimble, MD
principal investigator · Eastern Virginia Medical School/CONRAD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vaginosis, Bacterial→

Other studies from this sponsor

Eastern Virginia Medical School

Start the discussion