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

NCT01448291 | Unknown Phase 4

• 2 other identifiers: CRC-NVR1111-01-FB-0003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.Determine changes in the integrity of cervicovaginal epithelium and leukocytic concentration before and after treatment with NuvaRing®
3. 3.Monitor for changes in the Nugent score before and after NuvaRing® use
4. 4.Assess the antimicrobial activity of vaginal fluid before and after NuvaRing® use
5. 5.Assess HIV infectivity ex vivo on biopsy specimens before and after NuvaRing® use

Conditions

Vaginosis, Bacterial

Keywords

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

Outcome Measures

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

  3 months

Secondary Outcomes (1)

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

  Baseline and 3 months

Study Arms (1)

Nuvaring

EXPERIMENTAL

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

Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring DRUG

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

Also known as: NuvaRing®

Nuvaring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Clinical Research Center at Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 18154595 BACKGROUND

• 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.

  PMID: 12237628 BACKGROUND

• 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.

  PMID: 18635180 BACKGROUND

• 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.

  PMID: 16235171 BACKGROUND

• 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.

  PMID: 17911138 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginitis

Interventions

etonogestrel; NuvaRing

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Thomas D Kimble, MD

  Eastern Virginia Medical School/CONRAD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Caul

CONTACT

7574465808

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: October 7, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: March 1, 2013
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

US (1)