Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
NCT ID: NCT01448291
Last Updated: 2012-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2011-10-31
2013-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring
Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months
Interventions
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Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring
Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Eastern Virginia Medical School
OTHER
Responsible Party
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Thomas Kimble
Assistant Professor
Principal Investigators
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Thomas D Kimble, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School/CONRAD
Locations
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Clinical Research Center at Eastern Virginia Medical School
Norfolk, Virginia, United States
Countries
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Central Contacts
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Julia Caul
Role: CONTACT
Facility Contacts
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Julia Caul
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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11-01-FB-0003
Identifier Type: OTHER
Identifier Source: secondary_id
CRC-NVR11
Identifier Type: -
Identifier Source: org_study_id
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