Modulation of Immunity by Hormonal Contraceptives

Contraception Clinical Trial

Official title:

Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011711
• Other study ID #: 2013H0235
• Secondary ID: R01HD072663
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: January 12, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).

Description:

Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• not pregnant

• regular menstrual cycle

Exclusion Criteria:

• use of oral contraceptive or Mirena in 3 months prior to enrollment

• use of depot-medroxyprogesterone acetate in 6 months prior to enrollment

• diagnosis of sexually transmitted infection in 30 days prior to enrollment

• history of cervical malignancy

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
United States	Edwards Building	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Thomas L. Cherpes	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Quispe Calla NE, Ghonime MG, Cherpes TL, Vicetti Miguel RD. Medroxyprogesterone acetate impairs human dendritic cell activation and function. Hum Reprod. 2015 May;30(5):1169-77. doi: 10.1093/humrep/dev035. — View Citation

Quispe Calla NE, Vicetti Miguel RD, Boyaka PN, Hall-Stoodley L, Kaur B, Trout W, Pavelko SD, Cherpes TL. Medroxyprogesterone acetate and levonorgestrel increase genital mucosal permeability and enhance susceptibility to genital herpes simplex virus type 2 — View Citation

Quispe Calla NE, Vicetti Miguel RD, Mei A, Fan S, Gilmore JR, Cherpes TL. Dendritic cell function and pathogen-specific T cell immunity are inhibited in mice administered levonorgestrel prior to intranasal Chlamydia trachomatis infection. Sci Rep. 2016 Nov 28;6:37723. doi: 10.1038/srep37723. — View Citation

Quispe Calla NE, Vicetti Miguel RD, Trout W, Cherpes TL. HIV and Hormonal Contraception: Bench and Bedside. J Acquir Immune Defic Syndr. 2016 Sep 1. [Epub ahead of print] — View Citation

Vicetti Miguel RD, Hendricks RL, Aguirre AJ, Melan MA, Harvey SA, Terry-Allison T, St Leger AJ, Thomson AW, Cherpes TL. Dendritic cell activation and memory cell development are impaired among mice administered medroxyprogesterone acetate prior to mucosal herpes simplex virus type 1 infection. J Immunol. 2012 Oct 1;189(7):3449-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ectocervical permeability		Baseline and 1 month